TriangleNCT02130427 · REGISTRY CONDITION SEARCH
A Volume, Motion, and Anatomically Adaptive Approach to Photon and Proton Beam Radiotherapy
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- NA
- Status at capture
- COMPLETED
- Registry last update
- 2022-07-22
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- 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.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Weekly 3D/4D CT scans during radiation therapy. MRI may be used in addition to or instead of CT depending on the location of the tumor and the decision of the treating physician.
- intervention Names
- Diagnostic Test: CT scan
- label
- Lung Imaging
- type
- OTHER
- interventions
- arm Group Labels
- Lung Imaging
- description
- Weekly 3D/4D CT scan
- name
- CT scan
- type
- DIAGNOSTIC_TEST
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- intervention Model Description
- Pilot study
- masking Info
- masking
- NONE
- primary Purpose
- OTHER
Enrollment
- count
- 74
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Tumor Volume
- time Frame
- 9 weeks
Full study description
- 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.
Source references
Source notices and limitations
Discovery and provenance
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- Small Intestine Cancer
- query disease state id
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- source file
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Preserved source evidence · Not medical advice