Treatment of T2-T3/NO-N+ Adenocarcinoma of the Rectum by Neoadjuvant Chemotherapy (FOLFOX) Followed by Preoperative Chemo (Fluorouracil / Capecitabine)-Radio Therapy (CRT) With Watchful Waiting for Complete Responders
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this project is to determine if in a selected group of patients, at higher risk of wound dehiscence and other complications, treatment by local excision and management by a watchful waiting or an initial non-operative management approach, with an offer of radical resection only to those patients whose tumors demonstrate regrowth will maintain acceptable local control and overall survival rate for the whole cohort.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 95
Healthy Volunteers: f
View:
• Age ≥ 18 years
• Diagnosis of rectal invasive adenocarcinoma
• Tumor in the low rectum lying \< 4 cm from the anal verge
• Clinical stage T3/N0-N1M0.
• Patients with low T2 who will need abdominal perineal resection are also eligible.
Locations
United States
Michigan
Ascension St. John Hospital
RECRUITING
Detroit
Contact Information
Primary
Amr Aref, MD
amr.aref@ascension.org
(313) 647-3100
Time Frame
Start Date: 2018-07-10
Estimated Completion Date: 2029-07-09
Participants
Target number of participants: 30
Treatments
Experimental: Watchful Waiting
Six cycles of FOLFOX (infusional fluorouracil, leucovorin, and oxaliplatin) will be administered every two weeks according to protocol. After a 3 week recovery period, this will be followed by conventional concurrent radiation and 5FU/capecitabine.~Patients will be re-staged two to three weeks after completion of induction FOLFOX therapy to ensure no disease progression. The patients will be re-staged again at least 7-11 weeks post completion of nCRT. Patients with restaging results showing either complete or near complete response, will be allocated to watchful waiting.
Related Therapeutic Areas
Sponsors
Leads: Henry Ford Health System