NCT05194878 Neoadjuvant FOLFOXIRI Versus Immediate Surgery for Stage II and III Colon Cancers
| NCT ID | NCT05194878 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Colon Cancer Stage II |
| Study Type | INTERVENTIONAL |
| Enrollment | 840 participants |
| Start Date | 2021-12-01 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 840 participants in total. It began in 2021-12-01 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 effective at eradicating micrometastases. Moreover, shrinking tumor before surgery not only facilitate removal of all the tumor by the surgeon but also reduce tumor cell spreading during the procedure. With recent advances in radiology, preoperative computed tomography allows a good prediction of tumor stage (wall penetration and nodal involvement) prior to surgery. The investigators conducted the present randomized study to explore whether perioperative chemotherapy with FOLFOXIRI regimen compared with postoperative chemotherapy could improve disease-free survival in patients with radiologically staged, High-risk, but resectable Stage II or III colon cancer. OBJECTIVE: The primary objective of this study is to evaluate the efficacy of perioperative chemotherapy with FOLFOXIRI regimen compared to postoperative chemotherapy in patients with High-risk Resectable Stage II and III colon cancer. Secondary objectives are efficacy in terms of R0 resection rate, overall survival (OS), relapse-free survival (RFS), down-staging of primary tumors, and tolerability of perioperative therapy and postoperative complications.
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 spiral or multidetector CT: high risk T3 (tumor disruption of muscle wall and extension into pericolic fat with more than 5 mm protrusion into adjacent mesenteric fat) or T4 (tumor penetrates to the surface of the visceral peritoneum or directly invades or is adherent to adjacent organs or structures). * Patients presenting with acute colonic obstruction may enter the trial only after obstruction is relieved by a successful defunctioning stoma, and when recovered to a fitness level consistent with the other eligibility criteria * Adequate full blood count: WBC \>3.0 x109/l; Plts \>100 x109/l. Anaemia (Hb \< 10.0 g/dl) is not an exclusion, but should be corrected by transfusion prior to surgery and chemotherapy. If Hb remains low despite transfusions, surgery and chemotherapy can be given at the decision of the surgical and oncology teams. * Adequate renal biochemistry: serum creatinine was less than 1.5 times the normal value. * Adequate hepatobiliary function: serum total bilirubin and ALT were less than 1.5 times the normal value. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Any patient for whom radiotherapy is advised by the MDT * Strong evidence of distant metastases or peritoneal nodules (M1) * dMMR in immunohistochemical detection or MSI-L/MS-S in MSI test. * Peritonitis (secondary to perforated tumour) * Colonic obstruction that has not been defunctioned * Serious medical comorbidity, eg uncontrolled inflammatory bowel disease, uncontrolled angina or recent (\<6 months) MI * Another serious medical condition judged to compromise ability to tolerate neoadjuvant therapy and/or surgery * Any other malignant disease within the preceding 5 years with the exception of non-melanomatous skin cancer, carcinoma in situ and early stage disease with a recurrence risk \<5%
Frequently Asked Questions
Who can join the NCT05194878 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Colon Cancer Stage II. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05194878 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 840 participants.
Is NCT05194878 currently recruiting?
Yes, NCT05194878 is actively recruiting participants. Visit ClinicalTrials.gov or contact Sun Yat-sen University to inquire about joining.
Where is the NCT05194878 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05194878 clinical trial?
NCT05194878 is sponsored by Sun Yat-sen University. The trial plans to enroll 840 participants.
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