Evaluating the need for adjuvant chemotherapy in advanced colorectal cancer after preoperative treatment
Comparing the Treatment Efficacy in Clinical Local Advanced Colorectal Cancer (cTxN1/2M0) Following Preoperational Adjuvant Therapies and Pathologically Proved StageⅡ(pT0-3N0M0)With or Without Adjuvant Chemotherapy
This study is testing if patients with advanced colorectal cancer who have already had treatment before surgery really need more chemotherapy afterward to stay cancer-free.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 650 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT03748485 on ClinicalTrials.gov |
What this trial studies
This study investigates whether adjuvant chemotherapy is necessary for patients with locally advanced colorectal cancer who have undergone preoperative therapies and are diagnosed with pT0-3N0M0. Patients will be randomized into two groups: one receiving adjuvant chemotherapy and the other being monitored without additional treatment. The primary goal is to assess the three-year disease-free survival rate following surgery. Secondary outcomes will focus on long-term clinical results, including overall survival rates.
Who should consider this trial
Good fit: Ideal candidates include patients with preoperative clinical stage III colorectal cancer who have undergone initial treatment and are pathologically confirmed to have pT0-3N0M0.
Not a fit: Patients with other malignant tumors, severe complications requiring emergency surgery, or those with non-resectable lymph node metastasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients who may not need adjuvant chemotherapy, potentially reducing unnecessary treatment and its associated side effects.
How similar studies have performed: While the efficacy of adjuvant chemotherapy in similar contexts remains unclear, this study aims to clarify its necessity, making it a novel approach in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * preoperative clinical tumor stage III （TxN1-2M0）CRC * pathological proved CRC adenocarcinoma by endoscopic biopsy * Post operational pathological T0-3N0M0 without high risk factors of recurrence * Patient able to understand and sign written informed consent Exclusion Criteria: * Other malignant tumors history. * Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and abscesses). * Colorectal tumor extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately. * Non resectable lymph node metastasis. * American Society of Anesthesiologists (ASA) grading≥ IV and/or, Eastern Cooperative Oncology Group(ECOG) score≥ 2. * Physical or psychological dependence. * Pregnant or breast feeding women. * Not controlled pre-operational infection. * Enrolled in other clinical trials within 4 weeks. * Other clinical or laboratorial condition not recommended by investigators.
Where this trial is running
Guangzhou, Guangdong
- Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Jianping Wang, MD/PHD
- Email: wangjpgz@126.com
- Phone: +86 13808874808
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.