Evaluating the need for adjuvant chemotherapy in advanced colorectal cancer after preoperative treatment
Official title: 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
Run by Sixth Affiliated Hospital, Sun Yat-sen University · NCT03748485 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 650 (estimated) |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | April 30, 2019 |
| Main results expected | December 30, 2027 |
| Study ends | December 30, 2030 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT03748485 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.