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
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
- Colorectal Cancer
- Adjuvant Chemotherapy
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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