Biopsy Proven Non Small Cell Lung Cancer, Colorectal Cancer, Gastrointestinal Cancer, Gynecological Malignancy Requiring Definitive Radiotherapy, Head and Neck Cancer, Rectal Cancers
Conditions
Keywords
Adult subjects, NSCLC
Brief summary
This pilot study will determine changes over time in tumor volume/motion & patient anatomy, as well as dose distributions to normal organs. The study will inform medical decision-making about need for (and timing of) re-calibration of radiation dosimetry plans. Weekly CT and/or serial MR scans will be employed for those patients receiving 7-8 wks of radiation therapy. The study will enroll 30 patients in each stratum: Non small cell lung cancer (NSCLC), Head & Neck, gastrointestinal (GI) and Gynecologic tumor.
Detailed description
This is a pilot study to estimate the degree of tumor volume, tumor motion and patient anatomy change during treatment with photon or proton beam radiotherapy. Patients will undergo simulation with an MR scan and/or CT scan per best clinical practices, and 4D imaging will be employed as indicated, at the discretion of the treating radiation oncologist. Photon beam treatment plans and Proton beam treatment plans will be generated from these images. Based on the location of the primary tumor, patients will undergo either up to weekly 3D or 4D CT and/or serial MR scans during treatment. These images will be compared to the initial CT/MR scans used for treatment planning and analyzed for changes in tumor volume and tumor anatomic location. At the end of treatment, the frequent 3D or 4D CT and/or serial MR images will be compared to the initial treatment planning images to quantify the changes in tumor volume and tumor motion during the course of radiation treatment. Each CT and/or MR Scan will also be used to evaluate the changes in dose distribution to the target volumes and normal tissues that occur with the initial photon treatment plan and initial proton treatment. The changes in tumor volume, tumor motion and dose distribution during the course of radiation treatment will be analyzed to determine the effect of tumor changes on radiation treatment efficacy.
Interventions
DIAGNOSTIC_TESTCT scan
Weekly 3D/4D CT scan
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 and above. * Biopsy proven diagnosis of non-small cell lung cancer, small cell lung cancer, head and neck, esophageal, gastric, pancreatic, anal, hepatic, biliary, colorectal, cervical, endometrial, vaginal, vulvar, ovarian cancer and any other gastrointestinal or gynecological cancers requiring definitive radiotherapy alone with or without concurrent chemotherapy. * Able to provide written informed consent and comply with all study procedures. * Entire course of radiotherapy will be delivered at the University of Pennsylvania Perelman Center for Advanced Medicine.
Exclusion criteria
\- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Volume | 9 weeks | The degree of tumor volume, tumor motion and patient anatomy change during treatment with photon beam radiotherapy using 4D or 3D CT Scans and/or a serial of MR Imaging. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Imaging Weekly 3D/4D CT scans; MRI scans used at the discretion of the treating physician when the location of the tumor requires it. | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Imaging results not interpretable | 30 |
Baseline characteristics
| Characteristic | Imaging |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age, Continuous | 60.3 years STANDARD_DEVIATION 11.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 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 | 32 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 14 Participants |
| Tumor volume | 141.3 cm^3 STANDARD_DEVIATION 158.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Tumor Volume
The degree of tumor volume, tumor motion and patient anatomy change during treatment with photon beam radiotherapy using 4D or 3D CT Scans and/or a serial of MR Imaging.
Time frame: 9 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Completed Imaging | Tumor Volume | 93.55 cm^3 | Standard Deviation 63.77 |