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Clinical Trials in China / NCT03748485
Recruiting Not applicable

Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis

NCT03748485 · tracked via the Priya Life Science China tracker
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Phase
Not applicable
Started
2019-04-30
Last updated
2026-06-09

Condition(s) studied

Colorectal CancerAdjuvant Chemotherapy

Investigational drug(s) / intervention(s)

wait and watchadjuvant chemotherapy

wait and watch: clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0),without(wait and watch) adjuvant chemotherapy

adjuvant chemotherapy: clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0),with adjuvant chemotherapy

Study summary

Adjuvant chemotherapy was unnecessary in pathological stage Ⅱ colorectal cancer following initial treatment of surgery without high risk factors of recurrences. The treatment efficacy of adjuvant chemotherapy for pT1-3N0M0 colorectal cancer following preoperational chemotherapy or chemoradiotherapy remains unclear. Part of clinical local advanced colorectal cancer(cTxN1-2M0), which turn out to be pT0-3N0M0 after preoperational chemotherapy or chemoradiotherapy, might not really need adjuvant chemotherapy due to the down-stage efficacy of the preoperational treatments, or the misleading by lymph nodes false-positive imaging diagnosis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sixth Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03748485 on ClinicalTrials.gov ↗ ← All trials in China