Comparing chemotherapy before and after surgery for advanced colon cancer
Perioperative CapeOX Chemotherapy Versus Postoperative Chemotherapy for Locally Advanced Resectable Colon Cancer: An Open Label Randomized Controlled Phase III Trial
This study is testing whether giving chemotherapy before or after surgery can help people with advanced colon cancer have better treatment results and recover faster.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1370 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT03125980 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of administering capecitabine plus oxaliplatin chemotherapy either before or after surgery in patients with locally advanced colon cancer. The study aims to determine if perioperative chemotherapy can enhance treatment outcomes by potentially shrinking tumors and eliminating microscopic metastases prior to surgical intervention. The trial builds on previous phase II results that showed promising responses to neoadjuvant chemotherapy, with no disease progression observed in participants. By accurately staging patients before surgery, the study seeks to optimize treatment strategies and improve recovery times.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with locally advanced colon cancer who are eligible for surgery and meet specific health criteria.
Not a fit: Patients with a history of systemic chemotherapy for colon cancer or those with other active tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and reduced recovery times for patients with locally advanced colon cancer.
How similar studies have performed: Previous studies have shown promising results with neoadjuvant chemotherapy approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Department of Colorectal Surgery Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Sanjun Cai, M.D
- Email: caisanjuncsj@163.com
- Phone: +86-21-64175590
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.