Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy
Recruiting
Phase 3
Interventional Study
Colon Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 232 (estimated)
- Sponsor
- University Hospital, Rouen · Other
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About This Trial
The aim of this study is to determine whether chemotherapy prior to tumor removal (neoadjuvant chemotherapy), in patients undergoing treatment for colon cancer in occlusion (CCO), would improve the rate of patients able to benefit from "optimal" treatment, i.e. complete treatment (including all neoadjuvant and adjuvant chemotherapy cures).
This new strategy, which would combine chemotherapy befor…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years
* ECOG performance status 0 or 1
* Patients with obstructive colon cancer treated by defunctioning stoma
* Pathologically confirmed adenocarcinoma (≥10 cm from the anal verge- left transverse colon) - MSS/pMMR (microsatellites stable primary tumor) status
* Pati…
Contacts