Watchful Waiting for Complete Responders to Therapy in Rectal Cancer
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
Henry Ford Health System
30 participants
Jul 10, 2018
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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.
Exclusion Criteria4
- Age less than 18 years
- Other forms of cancer
- Tumors \>= 4 cm from the anal verge
- Tumors of other clinical stages than listed above
Interventions
Careful review of patient response with the hope of avoiding radical surgery.
Locations(1)
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NCT05526079