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

NCT03748485 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2026-01-28

No results posted yet for this 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.

Conditions

Interventions

BEHAVIORAL

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

DRUG

adjuvant chemotherapy

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

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Jianping Wang, MD/PHD · sixth affiliate hospital of Sun yatsen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2027-12-30
Completion
2030-12-30

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03748485 on ClinicalTrials.gov