This phase I trial studies the safety, side effects, and best dose of adaptive radiation therapy boost in combination with standard radiation therapy and chemotherapy in treating patients with rectal cancer. Standard treatment usually includes surgery to remove the rectum, called total mesorectal excision (TME). In many cases, patients first receive neoadjuvant therapy—treatment given before surgery—which may include chemotherapy, radiation therapy, or both. These treatments help shrink the tumor and improve the chances of cure. However, to improve quality of life and reduce the need for major surgery, there is growing interest in organ-preserving strategies. Adaptive stereotactic body radiation therapy (SBRT) is a highly precise form of radiation that allows doctors to safely give a higher dose to the tumor. Radiation therapy is usually planned using images taken during a session called simulation. While the treatment is customized for each patient, both tumors and nearby healthy tissues can move from day to day. In the past, to make sure the tumor got the full dose of radiation, doctors had to include extra space around it in the treatment plan. This meant that more healthy tissue was treated than ideally necessary. Recent advancements have introduced onboard diagnostic-quality imaging in radiation treatment machines, enabling more precise techniques like SBRT. The development of real-time imaging has led to a new approach called adaptive radiation therapy (ART). ART allows radiation treatment plans to be adjusted in real-time based on the patient's anatomy on the day of treatment. This precision enables higher radiation doses to be delivered to the tumor while minimizing exposure to surrounding healthy tissues. Large doses of radiation can be given in just a few treatments, and this is strong enough to treat the tumor without needing extra chemotherapy. Standard chemotherapy drugs, such as the FOLFOX regimen (leucovorin calcium, fluorouracil, and oxaliplatin), as well as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ART in combination with standard radiation therapy and chemotherapy may be a safe treatment for patients with rectal cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT07221058.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
Fox Chase Cancer CenterStatus: Active
Contact: Joshua E. Meyer
Phone: 215-728-2667
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of the rectal tumor boost after induction chemoradiation with 45 Gy and capecitabine for patients with T2-T3, N0-N1, M0 rectal cancer.
II. To determine the feasibility of a rectal boost utilizing a computed tomography-magnetic resonance (CT-MR) fusion that targets at least 90% of the rectal planning tumor volume (PTV_Eval) with the 80% prescribed dose while limiting the outer 3 mm of the rectal wall to no more than 50% of the prescription dose delivered to 0.1cc.
SECONDARY OBJECTIVES:
I. To estimate the efficacy of bi-weekly adaptive radiotherapy boost fractions by complete response rate, near complete response rate, and incomplete response rate as per Memorial Sloan Kettering Cancer Center (MSKCC) criteria.
II. To estimate total mesorectal excision (TME) free survival following treatment with the study regimen.
III. To estimate overall survival (OS) following treatment with the study regimen.
IV. To estimate early and late toxicity following treatment with the study regimen.
EXPLORATORY OBJECTIVES:
I. Evaluate bowel function by calculating the low anterior resection syndrome (LARS) score at baseline, week 13, during safety follow-up, re-staging, and during the long-term at 6 months, 12 months and 24 months follow up visits.
II. Measuring quality of life using the European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L) index at the same time points as the bowel function assessments.
III. Early response prediction by performing a complete rectal cancer protocol magnetic resonance imaging (MRI) after two weeks of chemoradiation to assess early response to treatment as a predictor for complete response to the entire course of treatment.
OUTLINE: This is a dose-escalation study of ART.
Patients receive standard capecitabine in combination with standard radiation therapy over 25 treatment fractions on study. Patients then undergo one boost ART treatment fraction every 2 weeks for up to 3 boost ART fractions in the absence of disease progression or unacceptable toxicity. Patients then receive standard FOLFOX regimen or single agent fluorouracil or capecitabine for 4 months on study. Patients also undergo CT and MRI scans, and blood sample collection throughout the study. Patients may also undergo an optional biopsy on study.
After completion of study treatment, patients are followed up at 90 days, 8 weeks, and then every 3-6 months for 5 years.
Lead OrganizationFox Chase Cancer Center
Principal InvestigatorJoshua E. Meyer
