Trial Summary
What is the purpose of this trial?This trial is testing a combination of radiation therapy and chemotherapy for patients with rectal cancer that hasn't spread. The goal is to see if this treatment can effectively shrink and eliminate the cancer without surgery. This approach has shown potential benefits in treatment compliance and outcomes.
Eligibility Criteria
This trial is for adults with stage I-IIIB non-metastatic rectal adenocarcinoma, confirmed by biopsy and MRI. Participants must have an ECOG performance status of 0-2, adequate blood cell counts, a detectable tumor not more than 12 cm from the anal verge, and agree to use contraception if applicable. Exclusions include prior treatments for rectal cancer, other recent malignancies (except certain skin cancers), uncontrolled illnesses like heart failure or infection, HIV with low CD4+ count or recent opportunistic infections.Inclusion Criteria
Platelets >100,000 cells/mm3
I am able to care for myself and perform daily activities.
Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document.
+8 more
Exclusion Criteria
I have not had radiation therapy to my pelvic area.
I do not have any serious illnesses like heart failure or uncontrolled infections.
I have been treated with oxaliplatin or capecitabine for cancer.
+6 more
Participant Groups
The study tests short course radiation therapy followed by FOLFOX chemotherapy in patients with rectal cancer who are not undergoing surgery. The goal is to validate the complete clinical response rate observed in earlier research. Patients' responses will be monitored using biopsies, blood tests for circulating tumor DNA (ctDNA), and quality-of-life assessments through the FACT-C questionnaire.
1Treatment groups
Experimental Treatment
Group I: Radiation + FOLFOXExperimental Treatment5 Interventions
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* Alternatively CAPOX (capecitabine and oxaliplatin) may be given for 5 cycles over 15 weeks.
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
FOLFOX regimen is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as FOLFOX for:
- Colorectal cancer
🇺🇸 Approved in United States as FOLFOX for:
- Colorectal cancer
🇨🇦 Approved in Canada as FOLFOX for:
- Colorectal cancer
🇯🇵 Approved in Japan as FOLFOX for:
- Colorectal cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of ColoradoAurora, CO
Washington University School of MedicineSaint Louis, MO
Mayo ClinicRochester, MN
University of Vermont Medical CenterBurlington, VT
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Who Is Running the Clinical Trial?
Washington University School of MedicineLead Sponsor