- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02130427
A Volume, Motion, and Anatomically Adaptive Approach to Photon and Proton Beam Radiotherapy
July 15, 2022 updated by: Abramson Cancer Center of the University of Pennsylvania
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Lung Imaging
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.
|
Weekly 3D/4D CT scan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor Volume
Time Frame: 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.
|
9 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jennifer Wei Zou, PhD, Abramson Cancer Center of the University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2010
Primary Completion (Actual)
October 1, 2019
Study Completion (Actual)
April 1, 2022
Study Registration Dates
First Submitted
May 1, 2014
First Submitted That Met QC Criteria
May 2, 2014
First Posted (Estimate)
May 5, 2014
Study Record Updates
Last Update Posted (Actual)
July 22, 2022
Last Update Submitted That Met QC Criteria
July 15, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPCC 08909
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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