Biliary Cancer, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Prostate Cancer
Conditions
Keywords
Radiation, Cancer, HDR, Brachytherapy, Training
Brief summary
Background: * One standard way of giving radiation is to combine external beam treatments with internal brachytherapy treatments, which involve short-range radiation therapy that gives a high dose of radiation directly to a cancer or to the area where cancer cells were removed. * Brachytherapy is done by placing hollow implant device(s) into the area to be treated and then moving a radiation source into each. The type of device depends on the type of cancer and the site to be treated. These devices can range from hollow applicators and needles to balloon-like equipment. Objectives: * To evaluate the quality of the brachytherapy procedure at the National Institutes of Health Radiation Oncology Branch. Eligibility: * Patients with cancer who could potentially benefit from high-dose brachytherapy as part of their treatment. Design: * In conjunction with their existing treatment, patients will be treated with high-dose brachytherapy as determined appropriate for their particular type of cancer and cancer history. * Each treatment will take place in the Radiation Oncology Clinic. * If the patient does not have implant devices, the clinic staff will insert them and check their placement through a computed tomography (CT) scan. * The calculations to determine the appropriate brachytherapy dose will take a few hours; the brachytherapy treatment itself will take between 10 and 30 minutes. * The number of brachytherapy treatments will vary according to the individual needs and requirements of each type of cancer and each patient. * Patients will return to the Radiation Oncology Clinic for follow-up visits at 1, 3, 6, 9, and 12 months after the completion of radiation therapy. Follow-up evaluations will include a medical history and physical examination, assessment of any side effects of radiation therapy, and a repeat of any imaging (i.e., CT, magnetic resonance imaging (MRI), X-ray) that was done at baseline to evaluate the tumor response.
Detailed description
BACKGROUND: * High dose rate brachytherapy (HDR) is a challenging technique utilized in many malignancies in order to deliver a high dose of radiation therapy to a tumor in a conformal fashion with a rapid dose fall-off with the objective of sparing normal surrounding tissue * HDR therapy has been targeted to particular subsites as an integral part of either definitive management or palliation for malignancy-related symptoms. OBJECTIVES: * The primary objective is to determine the quality of high dose rate brachytherapy implants performed in the radiation oncology branch. An implant will be adequate if 90% of the GTV receives 90% of the dose prescribed and 80% of the Gross Tumor Volume (GTV) receives 85% of the prescribed dose. An implant will be inadequate if the above dose limitations are not met. * To evaluate local control and late toxicity rates following brachytherapy at the NCI ROB * To increase the flow of oncology participants requiring brachytherapy to the National Cancer Institute (NCI) Radiation Oncology Branch (ROB), as these participants lend themselves to special study and have unique educational value for the purpose of educating nurses, medical students, residents, physicists, clinical fellows, and physicians. ELIGIBILITY: -Participants with cancer who could potentially benefit from the use of high dose rate brachytherapy as a component of their treatment. DESIGN: * Participants will undergo appropriate work-up and clinical evaluation to determine if high-dose brachytherapy would be beneficial in either primary treatment or palliation of their disease. Participants will be treated with high-dose brachytherapy appropriately sequenced with other modalities in their treatment regimen. This treatment will be administered in accordance with standard radiation oncology practice and per the ABS (American Brachytherapy Society) guidelines. * The participants disease status and toxicity outcomes will be documented for a 12-month period at 3-months intervals.
Interventions
DIAGNOSTIC_TESTCT
Obtained based on the sites of target, as clinical situation dictates and at each follow-up to determine local control.
DIAGNOSTIC_TESTPET Scan
When deemed necessary.
RADIATIONHigh Dose Radiation (HDR) Brachytherapy
Brachytherapy, the placement of a radioactive source close to a tumor, is a well-established part of the treatment of many malignancies, both for palliative and definitive applications. High dose brachytherapy is useful in many malignancies in order to deliver a high dose of radiation therapy to tumor in a conformal fashion with a rapid dose fall-off with the objective of sparing normal surrounding tissue.
DIAGNOSTIC_TESTMRI
When deemed necessary.
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: 1. Pathologically confirmed malignancy for which high-dose rate brachytherapy is appropriate as a component of their therapeutic regimen. 2. Age greater than 18 years of age. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 4. Participant must have a primary medical or surgical oncologist in the community or at National Cancer Institute (NCI) who is willing to collaborate with the Radiation Oncology Branch (ROB) staff in the clinical management of the participant. 5. Participants of childbearing or child- fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study. 6. Site-specific inclusion criteria (any one or more of the following): Gynecologic Cancers: Endometrial cancer * Participants at a higher risk of recurrence (because of either grade, myometrial invasion, lymphatic vascular space invasion, tumor size, lymph node status, tumor extension, presence or absence of surgical staging) * Participants who have suffered a recurrence at the vaginal cuff * Participants who are unable to undergo surgery and must have treatment for an inoperable primary endometrial cancer. Cervical cancer * Participants who are unable to undergo surgery and must have treatment for an inoperable primary cervical cancer. * Participants with locally advanced cervical cancer in whom brachytherapy will be integrated as a boost to external beam radiation either in a palliative or curative setting (definitive or post-operative setting). Lung cancer * Participants with an endobronchial component causing symptoms * Participants who cannot undergo resection because of poor lung function or distant lung metastasis Breast cancer * Infiltrating ductal carcinoma or ductal carcinoma in-situ (DCIS), stage T0, T1, and T2 less than or equal to 3.0 cm, N0 and M0, * Participants benefiting from high dose radiation (HDR) as either as a boost or accelerated partial breast irradiation regimen. Prostate Cancer -Participants with localized prostate cancer (T1b-T3b) in whom brachytherapy will be integrated as a boost to external beam radiation or used as monotherapy for definitive management.
Exclusion criteria
1. Cognitively impaired participants who cannot give informed consent. 2. Participants currently receiving concurrent investigational chemotherapeutic agents. 3. Participants receiving concomitant chemotherapy administration in the 5 days preceding brachytherapy (except for gynecological cancer patients who may have received concurrent chemotherapy as a component of their treatment regimen) 4. Pregnant or breast-feeding females are excluded because of the potential mutagenic effects on a developing fetus or newborn. 5. Clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), which in the judgment of the Principal or Associate Investigator would compromise the participant s ability to tolerate this therapy or are likely to interfere with the study procedures or results. 6. Participants who are in the estimation of the PI, deemed unable or unlikely to adhere to protocol treatment. 7. Abnormal bleeding times or active anti-coagulation therapy. * platelets less than 100,000 per mm(3) * Prothrombin time (PT)/Partial thromboplastin time (PTT) greater than 1.5 the upper normal limit (UNL) 8. Any participant or tumor/anatomical factors that may prevent brachytherapy apparatus from being properly and safely inserted and positioned and from radiation therapy being administered per American Brachytherapy Society (ABS) guidelines. 9. Participants whose malignancy has one or more of the following site-specific criteria disqualifying them from the study: 1\. Breast cancer: * Participants inappropriate for standard breast conservation therapy (Multicentric disease, inability to achieve clear margins); * male participants with breast cancer * autoimmune disorders, including systemic lupus erythematosus (SLE), Scleroderma, etc. * distant metastases; 2\. Prostate cancer: * distant metastases * lymph node metastases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Adequate High-Quality Brachytherapy Implants Reported Per Strata (Four Body Sites) and Combined Overall | All participants were assessed 1 week after last dose of high dose radiation (HDR) brachytherapy, an average of 1 week (no range). | An implant is adequate if 90% of the Gross Tumor Volume (GTV) receives 90% of the dose prescribed and 80% of the Clinical Tumor Volume (CTV) receives 85% of the prescribed dose. An implant is inadequate if the above criteria is not met. A GTV only applies to certain disease sites such as gynecologic cancer that have not been removed by surgery and CTV applies to prostate or gynecologic cancer that have been removed surgically. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Prostate Participants With Local Control | Assessed at 12 months after radiation | Local control of the prostate is defined as Biochemical recurrence. Biochemical recurrence is a serum prostatic specific antigen (PSA) more than 2 ng/dL above the post brachytherapy nadir, measured by at least 2 PSA measurements separated by 1 month, and the National Comprehensive Cancer Network (NCCN) guidelines. |
| Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall | Assessed at 12 months after radiation | Local control is defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD) of the treated site. In diseases where targets can be imaged, response will be measured using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria only for local sites. Complete Response is disappearance of the target lesion. Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of the target lesion taking into account the baseline sum LD. Stable Disease does not qualify for CR, PR, or progression. Progression is interval increase in the maximal dimension of the target lesion. Scoring of local control at each treated site will be based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria. Each site will be scored separately (Only for local sites) and the number of participants with CR, PR, SD will be determined. |
| Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall | Date treatment consent signed to date off study, approximately 159 months and 21 days. | The Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) Radiation Morbidity Scoring Scheme was used to score late toxicity following brachytherapy. Late toxicities are graded 0-5. Grade 0 is no symptoms. Grade 1 is mild/slight symptoms. Grade 2 is moderate. Grade 3 is severe. Grade 4 is severe/life-threatening. And Grade 5 is toxicity related to death. |
| Number of Participants Accrued Who Received Brachytherapy Each Year | Approximately 16 years | To help understand and increase the flow of participants receiving brachytherapy, the number of participants who received brachytherapy each year are reported. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria (CTC) v3.0 | Assessed at 12 months after radiation | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria (CTC v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Radiation Therapy Oncology Group (RTOG) | Assessed at 12 months after radiation | Here is the number of participants with serious and/or non-serious adverse events assessed by the RTOG. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gynecologic (Endometrial & Cervical) Participants received brachytherapy to the vaginal cuff or to the cervical or uterine tumor. Brachytherapy, the placement of a radioactive source close to a tumor, is a well-established part of the treatment of many malignancies, both for palliative and definitive applications. Participants will be treated with high-dose brachytherapy according to standard oncology practice and the American Brachytherapy Society (ABS) guidelines. Treatment will vary depending on the site of disease treated. | 28 |
| Pulmonary No participants were accrued to this group. | 0 |
| Breast No participants were accrued to this group. | 0 |
| Prostate Participants received brachytherapy to the prostate. | 15 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Further Follow-Up | 4 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 1 |
| Overall Study | Withdrawal: Refused further follow-up | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal: Refused further treatment | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal: Refused to start treatment | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Gynecologic (Endometrial & Cervical) | Prostate | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 11 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 4 Participants | 18 Participants |
| Age, Continuous | 65.8 years STANDARD_DEVIATION 12.4 | 68.4 years STANDARD_DEVIATION 7.1 | 66.7 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 15 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 8 Participants | 27 Participants |
| Region of Enrollment United States | 28 participants | 15 participants | 43 participants |
| Sex: Female, Male Female | 28 Participants | 0 Participants | 28 Participants |
| Sex: Female, Male Male | 0 Participants | 15 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 0 | 0 / 0 | 0 / 14 |
| other Total, other adverse events | 22 / 27 | 0 / 0 | 0 / 0 | 11 / 14 |
| serious Total, serious adverse events | 0 / 27 | 0 / 0 | 0 / 0 | 0 / 14 |
Outcome results
Primary
Number of Participants Who Had Adequate High-Quality Brachytherapy Implants Reported Per Strata (Four Body Sites) and Combined Overall
An implant is adequate if 90% of the Gross Tumor Volume (GTV) receives 90% of the dose prescribed and 80% of the Clinical Tumor Volume (CTV) receives 85% of the prescribed dose. An implant is inadequate if the above criteria is not met. A GTV only applies to certain disease sites such as gynecologic cancer that have not been removed by surgery and CTV applies to prostate or gynecologic cancer that have been removed surgically.
Time frame: All participants were assessed 1 week after last dose of high dose radiation (HDR) brachytherapy, an average of 1 week (no range).
Population: As pre-specified by the protocol, this outcome measure is reported per strata (body sites). No participants were accrued to the pulmonary and breast body sites. 27/28 participants were analyzed in the gynecologic group and 14/15 participants were analyzed in the prostate group because one participant in each group withdrew and refused to start treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gynecologic (Endometrial & Cervical) | Number of Participants Who Had Adequate High-Quality Brachytherapy Implants Reported Per Strata (Four Body Sites) and Combined Overall | 27 Participants |
| Pulmonary | Number of Participants Who Had Adequate High-Quality Brachytherapy Implants Reported Per Strata (Four Body Sites) and Combined Overall | 0 Participants |
| Breast | Number of Participants Who Had Adequate High-Quality Brachytherapy Implants Reported Per Strata (Four Body Sites) and Combined Overall | 0 Participants |
| Prostate | Number of Participants Who Had Adequate High-Quality Brachytherapy Implants Reported Per Strata (Four Body Sites) and Combined Overall | 14 Participants |
| Overall | Number of Participants Who Had Adequate High-Quality Brachytherapy Implants Reported Per Strata (Four Body Sites) and Combined Overall | 41 Participants |
Secondary
Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall
The Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) Radiation Morbidity Scoring Scheme was used to score late toxicity following brachytherapy. Late toxicities are graded 0-5. Grade 0 is no symptoms. Grade 1 is mild/slight symptoms. Grade 2 is moderate. Grade 3 is severe. Grade 4 is severe/life-threatening. And Grade 5 is toxicity related to death.
Time frame: Date treatment consent signed to date off study, approximately 159 months and 21 days.
Population: As pre-specified by the protocol, this outcome measure is reported per strata (body sites). No participants were accrued to the pulmonary and breast body sites. 27/28 participants were analyzed in the gynecologic group and 14/15 participants were analyzed in the prostate group because one participant in each group withdrew and refused to start treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gynecologic (Endometrial & Cervical) | Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall | Grade 0 | 0 Toxicities |
| Gynecologic (Endometrial & Cervical) | Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall | Grade 1 | 8 Toxicities |
| Gynecologic (Endometrial & Cervical) | Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall | Grade 2 | 14 Toxicities |
| Gynecologic (Endometrial & Cervical) | Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall | Grade 3 | 1 Toxicities |
| Gynecologic (Endometrial & Cervical) | Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall | Grade 4 | 1 Toxicities |
| Gynecologic (Endometrial & Cervical) | Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall | Grade 5 | 0 Toxicities |
| Prostate | Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall | Grade 5 | 0 Toxicities |
| Prostate | Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall | Grade 0 | 0 Toxicities |
| Prostate | Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall | Grade 3 | 1 Toxicities |
| Prostate | Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall | Grade 4 | 0 Toxicities |
| Prostate | Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall | Grade 1 | 17 Toxicities |
| Prostate | Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall | Grade 2 | 15 Toxicities |
| Overall | Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall | Grade 1 | 25 Toxicities |
| Overall | Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall | Grade 2 | 29 Toxicities |
| Overall | Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall | Grade 5 | 0 Toxicities |
| Overall | Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall | Grade 3 | 2 Toxicities |
| Overall | Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall | Grade 0 | 0 Toxicities |
| Overall | Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall | Grade 4 | 1 Toxicities |
Secondary
Number of Participants Accrued Who Received Brachytherapy Each Year
To help understand and increase the flow of participants receiving brachytherapy, the number of participants who received brachytherapy each year are reported.
Time frame: Approximately 16 years
Population: No participants were accrued to the pulmonary and breast group. 27/28 participants were analyzed in the gynecologic group and 14/15 participants were analyzed in the prostate group because one participant in each group withdrew and refused to start treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gynecologic (Endometrial & Cervical) | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2010 | 2 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2019 | 0 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2015 | 1 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2009 | 3 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2018 | 0 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2016 | 1 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2022 | 0 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2017 | 0 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2011 | 2 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2024 | 0 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2021 | 0 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2012 | 12 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2013 | 4 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2023 | 0 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2020 | 0 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2014 | 2 Participants |
| Prostate | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2010 | 0 Participants |
| Prostate | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2009 | 0 Participants |
| Prostate | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2012 | 0 Participants |
| Prostate | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2011 | 0 Participants |
| Prostate | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2013 | 0 Participants |
| Prostate | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2014 | 0 Participants |
| Prostate | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2015 | 0 Participants |
| Prostate | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2016 | 3 Participants |
| Prostate | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2017 | 1 Participants |
| Prostate | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2018 | 7 Participants |
| Prostate | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2019 | 1 Participants |
| Prostate | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2020 | 0 Participants |
| Prostate | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2021 | 1 Participants |
| Prostate | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2022 | 0 Participants |
| Prostate | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2023 | 0 Participants |
| Prostate | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2024 | 1 Participants |
| Overall | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2019 | 1 Participants |
| Overall | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2013 | 4 Participants |
| Overall | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2024 | 1 Participants |
| Overall | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2020 | 0 Participants |
| Overall | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2011 | 2 Participants |
| Overall | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2023 | 0 Participants |
| Overall | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2021 | 1 Participants |
| Overall | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2010 | 2 Participants |
| Overall | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2016 | 4 Participants |
| Overall | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2012 | 12 Participants |
| Overall | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2017 | 1 Participants |
| Overall | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2015 | 1 Participants |
| Overall | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2022 | 0 Participants |
| Overall | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2018 | 7 Participants |
| Overall | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2014 | 2 Participants |
| Overall | Number of Participants Accrued Who Received Brachytherapy Each Year | Year 2009 | 3 Participants |
Secondary
Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall
Local control is defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD) of the treated site. In diseases where targets can be imaged, response will be measured using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria only for local sites. Complete Response is disappearance of the target lesion. Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of the target lesion taking into account the baseline sum LD. Stable Disease does not qualify for CR, PR, or progression. Progression is interval increase in the maximal dimension of the target lesion. Scoring of local control at each treated site will be based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria. Each site will be scored separately (Only for local sites) and the number of participants with CR, PR, SD will be determined.
Time frame: Assessed at 12 months after radiation
Population: As pre-specified by the protocol, this outcome measure is reported per strata (body sites). The prostate group were intentionally reported separately because the assessment for local control is different between the prostate (e.g., biochemical recurrence) group and gynecologic (e.g., imaging) group. No participants were accrued to the pulmonary and breast body sites. 27/28 participants were analyzed in the gynecologic group because one participant withdrew and refused to start treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gynecologic (Endometrial & Cervical) | Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall | Not Evaluable | 2 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall | Partial Response | 0 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall | Complete Response | 25 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall | Stable Disease | 0 Participants |
| Pulmonary | Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall | Partial Response | 0 Participants |
| Pulmonary | Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall | Stable Disease | 0 Participants |
| Pulmonary | Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall | Complete Response | 0 Participants |
| Pulmonary | Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall | Not Evaluable | 0 Participants |
| Breast | Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall | Complete Response | 0 Participants |
| Breast | Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall | Partial Response | 0 Participants |
| Breast | Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall | Stable Disease | 0 Participants |
| Breast | Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall | Not Evaluable | 0 Participants |
| Prostate | Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall | Partial Response | 0 Participants |
| Prostate | Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall | Complete Response | 25 Participants |
| Prostate | Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall | Not Evaluable | 2 Participants |
| Prostate | Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall | Stable Disease | 0 Participants |
Secondary
Number of Prostate Participants With Local Control
Local control of the prostate is defined as Biochemical recurrence. Biochemical recurrence is a serum prostatic specific antigen (PSA) more than 2 ng/dL above the post brachytherapy nadir, measured by at least 2 PSA measurements separated by 1 month, and the National Comprehensive Cancer Network (NCCN) guidelines.
Time frame: Assessed at 12 months after radiation
Population: As pre-specified by the protocol, this outcome measure is reported per strata (body sites). No participants were accrued to the pulmonary and breast body sites. 14/15 participants were analyzed in the prostate group because one participant withdrew and refused to start treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gynecologic (Endometrial & Cervical) | Number of Prostate Participants With Local Control | Biochemical recurrence | 0 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Prostate Participants With Local Control | No recurrence | 14 Participants |
| Gynecologic (Endometrial & Cervical) | Number of Prostate Participants With Local Control | Not evaluable | 0 Participants |
Other Pre-specified
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria (CTC) v3.0
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria (CTC v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Assessed at 12 months after radiation
Population: No participants were accrued to the pulmonary and breast group. And no participants were assessed for adverse events in the prostate group using the CTCv3.0. 26/28 participants were analyzed in the gynecologic group because one participant withdrew and refused to start treatment, and one participant did not complete brachytherapy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gynecologic (Endometrial & Cervical) | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria (CTC) v3.0 | 22 Participants |
| Pulmonary | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria (CTC) v3.0 | 0 Participants |
| Breast | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria (CTC) v3.0 | 0 Participants |
| Prostate | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria (CTC) v3.0 | 0 Participants |
| Overall | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria (CTC) v3.0 | 22 Participants |
Other Pre-specified
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Radiation Therapy Oncology Group (RTOG)
Here is the number of participants with serious and/or non-serious adverse events assessed by the RTOG. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Assessed at 12 months after radiation
Population: No participants were accrued to the pulmonary and breast group. 27/28 participants were analyzed in the gynecologic group and 4/15 participants were analyzed in the prostate group because one participant refused to start treatment in each group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gynecologic (Endometrial & Cervical) | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Radiation Therapy Oncology Group (RTOG) | 19 Participants |
| Pulmonary | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Radiation Therapy Oncology Group (RTOG) | 0 Participants |
| Breast | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Radiation Therapy Oncology Group (RTOG) | 0 Participants |
| Prostate | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Radiation Therapy Oncology Group (RTOG) | 11 Participants |
| Overall | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Radiation Therapy Oncology Group (RTOG) | 30 Participants |