Adaptive Radiation Boost for Rectal Cancer
Adaptive Radiation BOost for Rectal Cancer: a Phase I Dose Escalation Study (ARBOR)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether extra radiation after standard radiation and chemotherapy is safe and helpful for adults with rectal cancer. MRI scans guide changes to the extra radiation as the tumor responds. Researchers want to better target aggressive cancer cells, protect healthy tissue, and reduce side effects.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older, with rectal adenocarcinoma confirmed by a tissue or cell test.
- Cancer must be stage T2–3, N0–1, M0, based on scans. This means certain levels of growth into or through the rectal wall, limited or no nearby lymph node spread, and no spread to distant parts of the body.
- Willing to have MRI scans.
- Fully active or able to do light work, even if hard physical activity is limited.
- Expected to live at least 12 months.
- Blood tests must show enough infection-fighting cells and platelets, which help blood clot. A liver-related blood test called bilirubin must be below 3 mg/dL.
- Able to receive the planned chemotherapy before and after the extra radiation.
- Able to understand the study and willing to sign study consent and health privacy forms.
Who can't join
- Past treatment for rectal cancer.
- Cancer growing into the anal canal, the passage where stool leaves the body. Cancer touching but not entering it is allowed.
- Currently receiving another experimental treatment.
- Past radiation to the pelvis, the lower belly area.
- Cancer actively treated within the past 3 years, except non-melanoma skin cancer.
- An uncontrolled illness, such as an active infection or serious heart problem, or a mental health or social situation that would prevent following study requirements.
- Any other condition that the treating doctor believes would make the extra radiation unsafe.
- Pregnant or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Subjects must have histologically or cytologically confirmed rectal adenocarcinoma. 2. 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. 3. Subjects must be willing to undergo MRI scans. 4. Age ≥18 years. 5. ECOG performance status 0 or 1. 6. Estimated survival of ≥ 12 months. 7. 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 8. 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 9. 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 Criteria: 1. Subjects who have been previously treated for rectal cancer are excluded. 2. Subjects with rectal cancer involving the anal canal are excluded. (Rectal cancer abutting the anal canal will be allowed.) 3. Subjects must not be receiving any other investigational agents. 4. Subjects may not have had prior pelvic radiation. 5. Subjects should not have had a cancer actively treated within the last 3 years, excluding non-melanoma skin cancer. 6. 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. 7. Any condition or significant co-morbidity that prevents safe delivery of ART per the discretion of the treating physician(s). 8. Subjects must not be pregnant or breast-feeding.
Study sites (1)
PA
- Fox Chase Cancer Center · Philadelphia, PA 19111Joshua Meyer, MD · Study contact · 267-449-1431 · Joshua.Meyer@fccc.eduJianli Hu, MD, PhD · Study contact · 2674491431 · Jianli.Hu@fccc.eduMore trials in Philadelphia