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Conformal Radiation Therapy in Treating Patients With Metastatic Cancer Outside the Brain

A Phase II Study of Hypofractionated Highly Conformal Radiation With Helical Tomotherapy for Extra-Cranial Oligo

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00550654
Enrollment
1
Registered
2007-10-30
Start date
2007-10-31
Completion date
2010-05-31
Last updated
2017-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer, Melanoma (Skin), Metastatic Cancer, Ovarian Cancer, Sarcoma, Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific, recurrent adult soft tissue sarcoma, recurrent melanoma, recurrent osteosarcoma, recurrent renal cell cancer, recurrent uterine sarcoma, stage IV adult soft tissue sarcoma, stage IV melanoma, stage IV uterine sarcoma, ovarian sarcoma, chondrosarcoma, metastatic osteosarcoma, stage IV renal cell cancer, lung metastases, liver metastases, bone metastases

Brief summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase II trial is studying how well conformal radiation therapy works in treating patients with metastatic cancer outside the brain.

Detailed description

OBJECTIVES: Primary * To evaluate local control (defined as absence of local progression) at all treated sites of metastatic disease in patients with extracranial oligometastases treated with ablative doses of highly conformal radiotherapy delivered with helical tomotherapy. * To evaluate local control at each treated site of metastatic disease in these patients. Secondary * To determine median time to local progression in patients treated with this regimen. * To evaluate interfraction and intrafraction motion with megavoltage computed tomography (CT) imaging based on site of metastasis in these patients. * To compare tumor growth during systemic therapy in tumors treated with targeted radiotherapy vs newly developed tumors that have not been treated with radiotherapy. * To evaluate if treatment with hypofractionated highly conformal radiotherapy with helical tomotherapy can improve pain scores and decrease the need for analgesia in these patients. OUTLINE: Patients are stratified according to histology (renal cell carcinoma vs melanoma vs sarcoma vs other histologies). Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions. Patients undergo megavoltage imaging before and after each fraction to verify the positioning of each target lesion. Patients complete a pain assessment questionnaire at baseline and at 1 and 3 months after treatment. After completion of study therapy, patients are followed at 1 and 3 months and then every 3 months for up to 1 year.

Interventions

OTHERquestionnaire administration

Patients complete a pain assessment questionnaire, Brief Pain Inventory at baseline and at 1 and 3 months after treatment.

RADIATION3-dimensional conformal radiation therapy

Conformal radiation therapy improves the ability to spare normal tissues.

RADIATIONhypofractionated radiation therapy

Hypofractionated radiation therapy is delivered to maximize pain relief while minimizing patient impact if life expectancy is short.

Image guided radiation therapy targets the specific site of disease.

RADIATIONtomotherapy

Tomotherapy is a delivery method which provides megavoltage computed tomography (CT) localization and may provide superior conformality and localization compared to other dynamic intensity modulated radiation therapy techniques.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
National Institutes of Health Clinical Center (CC)
Lead SponsorNIH

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

DISEASE CHARACTERISTICS: * Pathologically confirmed cancer * No active disease at the primary site as assessed by physical examination, clinical evaluation, or site-specific imaging * Measurable metastatic disease meeting the following criteria: * Four or fewer sites of extracranial lesions \< 5 cm in size * If metastatic site(s) is within the lung, the following criteria must be met: * No more than two metastases in the proximal bronchial tree area (defined as 2 cm from the trachea or mainstem bronchi) * Carbon monoxide diffusing capacity (DLCO) \> 30% predicted and forced expiratory volume 1 (FEV1) \> 1.2 L (in patients with more than one metastatic site in the lungs) * If metastatic site(s) is within 2 cm of either kidney, creatinine level must be \< 1.5 times upper limit of normal (ULN) * If metastatic site(s) is within 2 cm of the liver, bilirubin level must be \< 1.5 times ULN * Patients with metastatic disease that meets any of the following criteria are excluded: * Proposed site(s) of treatment has been previously treated with radiotherapy * Metastatic site(s) requires emergent treatment (e.g., spinal cord compression, cauda equina, airway compromise, or life-threatening end-organ dysfunction) * Disease that is untreated or previously treated and progressive in the brain * Pathologic fracture or impending pathologic fracture at the metastatic site * Metastatic site(s) of a disease histology that is known to be sensitive to low doses of radiotherapy (e.g., pure seminoma, lymphoma, or small cell carcinoma) * Patients in whom surgery is deemed an appropriate option as standard of care (e.g., isolated lung metastasis from sarcoma or isolated liver metastasis from colon cancer) but who refuse surgical therapy are eligible PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Life expectancy \> 12 weeks as assessed by the consulting radiation oncologist * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of lupus erythematosus or scleroderma * No known hypersensitivity to therapeutic radiotherapy * No other malignancy within the past 2 years except nonmelanoma skin cancer or in situ malignancies of the cervix, bladder, or head and neck * No unrelated systemic illness that, in the judgment of the investigator, would compromise the patient's ability to tolerate study therapy or would likely interfere with study procedures or results * Able or likely to adhere to study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 2 weeks since prior and no concurrent chemotherapy * Prior or concurrent hormonal agents, including antiandrogens, gonadotropin-releasing hormone agonists, aromatase inhibitors, tamoxifen, or similar agents allowed * No change in systemic therapy for 6 weeks before or within 4 weeks after initiating study radiotherapy

Design outcomes

Primary

MeasureTime frameDescription
6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease6 monthsLocal control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a \>/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression.Progression is an interval increase in the maximal dimension of the target lesion.

Secondary

MeasureTime frameDescription
Number of Participants With Adverse Events9 months, 11 daysHere is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Median Time to Local Progression6-12 monthsInterval from initiation of treatment on protocol to symptomatic or radiographic progression.
Pain at Sites of MetastasesOne and three months of follow upImprovement in pain from baseline will be assessed by the Brief Inventory for Pain criteria.
Interfraction and Intrafraction Motion With Megavoltage Computed Tomography (CT) Based on Sites of MetastasisOne to three months of followupMegavoltage localization scans will be obtained and the physician and therapist will evaluate the cone beam image and compare this image to the expected image based on the patient's initial planning CT scan.
Tumor Doubling Times During Systemic Treatment Compared Between Tumors Untreated With Radiation (Newly Developed Tumors) and Tumors Which Have Received Radiation TherapyBaseline and prior to termination of systemic therapy or protocol withdrawalRate of growth of the composite (total) treated volume (up to four sites) compared to the composite volume of up to four newly identified and untreated prospectively-identified (at the time of systemic progression) metastatic sites. Volume doubling time will be calculated assuming an exponential growth pattern.
12 Month Local Control in All Sites of Treatment, and at Each Site of Treatment12 monthsLocal control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a \>/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression. Progression is an interval increase in the maximal dimension of the target lesion.

Countries

United States

Participant flow

Participants by arm

ArmCount
Radiation Therapy in Metastatic Cancer
Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
1
Total1

Baseline characteristics

CharacteristicRadiation Therapy in Metastatic Cancer
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
1 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous71.6 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Gender
Female
0 Participants
Gender
Male
1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
1 Participants
Region of Enrollment
United States
1 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
1 / 1
serious
Total, serious adverse events
0 / 1

Outcome results

Primary

6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease

Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a \>/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression.Progression is an interval increase in the maximal dimension of the target lesion.

Time frame: 6 months

Population: No data/specimens were collected. Study was terminated due to poor accrual.

Secondary

12 Month Local Control in All Sites of Treatment, and at Each Site of Treatment

Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a \>/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression. Progression is an interval increase in the maximal dimension of the target lesion.

Time frame: 12 months

Population: No data/specimens were collected. Study was terminated due to poor accrual.

Secondary

Interfraction and Intrafraction Motion With Megavoltage Computed Tomography (CT) Based on Sites of Metastasis

Megavoltage localization scans will be obtained and the physician and therapist will evaluate the cone beam image and compare this image to the expected image based on the patient's initial planning CT scan.

Time frame: One to three months of followup

Population: No data/specimens were collected. Study was terminated due to poor accrual.

Secondary

Median Time to Local Progression

Interval from initiation of treatment on protocol to symptomatic or radiographic progression.

Time frame: 6-12 months

Population: No data/specimens were collected. Study was terminated due to poor accrual.

Secondary

Number of Participants With Adverse Events

Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

Time frame: 9 months, 11 days

ArmMeasureValue (NUMBER)
Radiation Therapy in Metastatic CancerNumber of Participants With Adverse Events1 Participants
Secondary

Pain at Sites of Metastases

Improvement in pain from baseline will be assessed by the Brief Inventory for Pain criteria.

Time frame: One and three months of follow up

Population: No data/specimens were collected. Study was terminated due to poor accrual.

Secondary

Tumor Doubling Times During Systemic Treatment Compared Between Tumors Untreated With Radiation (Newly Developed Tumors) and Tumors Which Have Received Radiation Therapy

Rate of growth of the composite (total) treated volume (up to four sites) compared to the composite volume of up to four newly identified and untreated prospectively-identified (at the time of systemic progression) metastatic sites. Volume doubling time will be calculated assuming an exponential growth pattern.

Time frame: Baseline and prior to termination of systemic therapy or protocol withdrawal

Population: No data/specimens were collected. Study was terminated due to poor accrual.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026