RecruitingNot ApplicableNCT03748485

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

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


Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

650 participants

Start Date

Apr 30, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether patients with locally advanced colorectal cancer who responded very well to pre-surgery treatment (reaching a near-complete response) actually benefit from additional chemotherapy after surgery, or whether it may be safely skipped. **You may be eligible if...** - You were diagnosed with Stage III colorectal cancer before surgery - You received treatment before surgery (neoadjuvant therapy) and your final surgical pathology showed no remaining cancer in lymph nodes (pathological stage T0–T3N0M0) without high-risk features - Your cancer was confirmed as adenocarcinoma (the most common type) by biopsy - You are able to understand and sign a consent form **You may NOT be eligible if...** - You have had other cancers in the past - You needed emergency surgery for complications - Your cancer had spread to distant organs - You had high-risk features (such as lymph node involvement) on final pathology Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALwait 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

DRUGadjuvant chemotherapy

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


Locations(1)

Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT03748485


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