Status:
RECRUITING
Adaptive Radiation Boost for Rectal Cancer
Lead Sponsor:
Fox Chase Cancer Center
Collaborating Sponsors:
Varian Medical Systems
Conditions:
Rectum Cancer, Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- Subjects must have histologically or cytologically confirmed rectal adenocarcinoma.
- Subjects must have T2-3, N0-1, M0 rectal cancer. Staging will be done by MRI pelvis and CT chest and abdomen with contrast. PET-CT will be an acceptable alternative for the CT chest and abdomen.
- Subjects must be willing to undergo MRI scans.
- Age ≥18 years.
- ECOG performance status 0 or 1.
- Estimated survival of ≥ 12 months.
- Subjects must have normal organ and marrow function as defined below
- Absolute neutrophil count \> =1,000/mcL
- Platelets \>= 75,000/mcL
- Total bilirubin \< 3 mg/dL
- Subjects must be able to tolerate the chemotherapy regimens outlined in the treatment plan (Section 5.0), both before and after ART.
- Before ART: Capecitabine at a dose of 825 mg/m²
- After ART: FOLFOX combination chemotherapy, or 5-FU, or capecitabine
- Subjects must possess the ability to understand and willingness to sign a written informed consent and HIPAA consent document. Translation services including translation of informed consent documents will be provided, as feasible, to encourage diversity of inclusion of eligible patients.
Exclusion
- Subjects who have been previously treated for rectal cancer are excluded.
- Subjects with rectal cancer involving the anal canal are excluded. (Rectal cancer abutting the anal canal will be allowed.)
- Subjects must not be receiving any other investigational agents.
- Subjects may not have had prior pelvic radiation.
- Subjects should not have had a cancer actively treated within the last 3 years, excluding non-melanoma skin cancer.
- Subjects must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Any condition or significant co-morbidity that prevents safe delivery of ART per the discretion of the treating physician(s).
- Subjects must not be pregnant or breast-feeding.
Key Trial Info
Start Date :
October 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT07221058
Start Date
October 24 2025
End Date
November 1 2029
Last Update
December 9 2025
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111