Watchful Waiting for Complete Responders to Therapy in Rectal Cancer
Recruiting
Phase 2
Interventional Study
Rectal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 95
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Henry Ford Health System · Other
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About This Trial
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 overa…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18 years
2. Diagnosis of rectal invasive adenocarcinoma
3. Tumor in the low rectum lying \< 4 cm from the anal verge
4. Clinical stage T3/N0-N1M0.
5. Patients with low T2 who will need abdominal perineal resection are also eligible.
Exclusion Criteria:
1. Age less tha…
Contacts