Neoadjuvant FOLFOXIRI Versus Immediate Surgery for Stage II and III Colon Cancers
Recruiting
Phase 3
Interventional Study
Colon Cancer Stage II
Colon Cancer Stage III
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 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 840 (estimated)
- Sponsor
- Sun Yat-sen University · Other
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About This Trial
BACKGROUND:
In patients with high risk stage II and stage III colon cancer (CC), curative surgery followed by adjuvant chemotherapy with FOLFOX or CAPOX regimens has become a standard treatment. However, 20 to 30 % of these patients will develop distant metastasis, which ultimately result in death. Perioperative chemotherapy is a promising strategy with potential benefits that could be more effec…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Histologically proven adenocarcinoma or high grade dysplasia on histology plus unequivocal radiological evidence of invasive cancer of the colon(≥ 12 cm from the anal verge).
* pMMR in immunohistochemical detection or MSI-H in MSI test.
* Determined preoperatively by either sp…
Contacts
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