Perioperative Versus Postoperative CapOX Chemotherapy for Locally Advanced Colon Cancer

Launched by FUDAN UNIVERSITY · Apr 19, 2017

Keywords

ClinConnect Summary

This clinical trial is studying two different approaches to chemotherapy for patients with locally advanced colon cancer: one that starts before surgery (called perioperative or neoadjuvant chemotherapy) and one that starts after surgery (called postoperative chemotherapy). The goal is to see which method is more effective and safer. Early studies have shown that starting chemotherapy before surgery may help shrink the tumor and make surgery easier, which could lead to faster recovery.

To participate in this trial, patients should be generally healthy enough to undergo surgery and meet certain medical criteria, such as having adequate blood counts and organ function. Participants will receive either the pre-surgery or post-surgery chemotherapy and will be monitored for their response to treatment and any side effects. The trial aims to enroll nearly 1,000 participants initially, and if the results indicate that one approach is significantly better, the study might conclude early. Overall, this research could provide valuable information on the best timing for chemotherapy in treating colon cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2;
• • Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: Neutrophil count≥1.5×109/L, Platelet count≥100×109/L, Hemoglobin≥80g/L, Serum bilirubin≤24umol/L, Alanine aminotransferase and aspartate aminotransferase ≤ 60×IU/L, Serum creatinine≤110 umol/L;
• • No current pregnancy or breast-feeding, and subjects at childbearing age shall take method of contraception ;
• • Be in a condition to receive a surgery/procedure;
• • No second tumor at present or in the past 5 years, except skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;
• • No previous systemic chemotherapy for treating colon cancer;
• • No other chemotherapy at the same time;
• • Expected lifetime longer than three months;
• • Be willing and able to understand the study and to provide written informed consent.
• Exclusion Criteria:
• • End-stage cachexia patients;
• • Cardiopulmonary dysfunction or liver and kidney dysfunction, and unable to tolerate CapeOX chemotherapy;
• • Metastatic carcinoma;
• • Moderate or above anemia caused by serious local tumor bleeding;
• • Incomplete or complete intestinal obstruction;
• • Known to be allergic to oxaliplatin or capecitabine;
• • Active hepatitis, severe coagulation disorder patients;
• • Pregnant or lactating women; or women who have fertility but have not taken at taken adequate contraceptive measures;
• • Known to have deficient dihydropyrimidine dehydrogenase (DPD)；
• • Have vital organ failure or other severe diseases, including but not limited to coronary heart disease, cardiovascular diseases, or myocardial infarction within 12 months before being included; severe neurological or psychiatric history；severe infection; active disseminated intravascular coagulation;
• • Unable or unwilling to abide by the study plan.