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.
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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…
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