Status:
RECRUITING
Neoadjuvant FOLFOXIRI Versus Immediate Surgery for Stage II and III Colon Cancers
Lead Sponsor:
Sun Yat-sen University
Conditions:
Colon Cancer Stage II
Colon Cancer Stage III
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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. Howe...
Detailed Description
This trial is a a two-arm, multicenter, open labelled, prospective, randomized phase III studies. Eligible patients with High-risk Resectable Stage II and III (T4 or T3 with extramural depth≧5 mm) col...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT05194878
Start Date
December 1 2021
End Date
December 1 2026
Last Update
January 18 2022
Active Locations (1)
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1
651 Dongfeng Road East
Guangzhou, Guangdong, China, 510060