NCT07221058RecruitingPhase 1
Adaptive Radiation Boost for Rectal Cancer
Adaptive Radiation BOost for Rectal Cancer: a Phase I Dose Escalation Study (ARBOR)
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 37 (estimated)
- First submitted
- 22 Oct 2025
- Start date
- 24 Oct 2025
- Primary completion date
- 1 Nov 2028
- Lead sponsor
- Fox Chase Cancer Center
- Diseases
- Colorectal cancer
- NCT number
- NCT07221058
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 37
- From 24 Oct 2025 to the primary completion date, 1 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who have been previously treated for rectal cancer are excluded.
- Subjects must not be receiving any other investigational agents.
- Subjects may not have had prior pelvic radiation.
Other illness
- Subjects with rectal cancer involving the anal canal are excluded. (Rectal cancer abutting the anal canal will be allowed.)
- 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).
Other
- Subjects must not be pregnant or breast-feeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.