Neoadjuvant chemotherapy versus immediate surgery for high-risk colon cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 651 Dongfeng Road East
  Guangzhou, Guangdong, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.