Actively Recruiting
Adaptive Radiation Boost for Rectal Cancer
Led by Fox Chase Cancer Center · Updated on 2025-12-09
37
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
Sponsors
F
Fox Chase Cancer Center
Lead Sponsor
V
Varian Medical Systems
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to find out if giving extra adaptive radiation therapy after standard chemoradiation treatment is safe and helpful for people with rectal cancer. The main questions the study aims to answer are: * Can this approach help target the most aggressive cancer cells more accurately, while protecting nearby healthy tissue? * Can it reduce the side effects that people may experience during treatment? Participants will: * First receive standard treatment: radiation (45 Gy in 25 sessions) along with a chemotherapy pill called capecitabine. * Then get extra radiation using MRI scans every two weeks to adjust the treatment based on how the tumor responds. * Use a small balloon during treatment to help aim the radiation and protect healthy areas. * Finally, receive additional chemotherapy (such as FOLFOX) for four months.
CONDITIONS
Official Title
Adaptive Radiation Boost for Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed rectal adenocarcinoma
- Rectal cancer stage T2-3, N0-1, M0 confirmed by MRI pelvis and CT chest and abdomen or PET-CT
- Willingness to undergo MRI scans
- Age 18 years or older
- ECOG performance status of 0 or 1
- Estimated survival of 12 months or more
- Normal organ and marrow function including neutrophil count ≥1000/mcL, platelets ≥75,000/mcL, and total bilirubin <3 mg/dL
- Ability to tolerate chemotherapy before and after adaptive radiotherapy (Capecitabine before ART; FOLFOX, 5-FU, or capecitabine after ART)
- Ability and willingness to understand and sign informed consent and HIPAA documents
You will not qualify if you...
- Previous treatment for rectal cancer
- Rectal cancer involving the anal canal (except abutting the anal canal)
- Receiving other investigational agents
- Prior pelvic radiation
- Cancer actively treated within the last 3 years, excluding non-melanoma skin cancer
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting compliance
- Any condition or co-morbidity preventing safe delivery of adaptive radiotherapy
- Pregnancy or breastfeeding
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Trial Site Locations
Total: 1 location
1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
Research Team
J
Joshua Meyer, MD
CONTACT
J
Jianli Hu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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