Neoadjuvant chemotherapy versus immediate surgery for high-risk colon cancer
Phase III Study of Neoadjuvant FOLFOXIRI Chemotherapy Versus Immediate Surgery for High-risk Resectable Stage II and III Colon Cancers
This study is testing whether giving chemotherapy before surgery can help people with high-risk colon cancer live longer and healthier compared to having surgery right away.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 840 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05194878 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of neoadjuvant chemotherapy using the FOLFOXIRI regimen compared to immediate surgery followed by adjuvant chemotherapy in patients with high-risk stage II and III colon cancer. It is a multicenter, open-label, randomized phase III study where eligible patients will be assigned to one of the two treatment arms. The goal is to determine if administering chemotherapy before surgery can improve disease-free survival by potentially eradicating micrometastases and facilitating tumor removal. The study utilizes advanced imaging techniques to assess tumor staging prior to treatment.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed high-risk stage II or III colon cancer who meet specific radiological and health criteria.
Not a fit: Patients with low-risk colon cancer or those who cannot undergo surgery or chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved disease-free survival rates for patients with high-risk colon cancer.
How similar studies have performed: Other studies have shown promise with neoadjuvant chemotherapy approaches, suggesting potential benefits, although this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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%
Where this trial is running
Guangzhou, Guangdong
- 651 Dongfeng Road East — Guangzhou, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.