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Recruiting NCT03748485

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

No phase Interventional Colorectal Cancer Adjuvant Chemotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: wait and watch, adjuvant chemotherapy.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Adjuvant Chemotherapy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Detailed description

Colorectal cancer(CRC) nowadays rank the 3rd incidence and the 4th mortality in all cancers worldwide(ref). Although the coloscopy or liquid biopsy screen has improved the early diagnosis of CRC, about 26.5-36.0% of the patients were diagnosed local advanced CRC at the first visit. Part of clinical local advanced colorectal cancer(cTxN1-2M0), which turn out to be pT1-3N0M0 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. Adjuvant chemotherapy was been admitted unnecessary in the pathological stage ⅡA (pT0-3N0M0) CRC following initial treatment of surgery without high risk factors of recurrences. The treatment efficacy of adjuvant chemotherapy for pT1-3N0M0 CRC following preoperational chemotherapy or chemoradiotherapy remains unclear. The aim of this study is to evaluate the efficacy/safety of adjuvant chemotherapy in clinical local advanced CRC (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved pT0-3N0M0 CRC. Patients are randomized to control group(down-staged pT0-3N0M0 CRC with 6 to 8 periods adjuvant chemotherapy) and experimental group(watch group, down-staged pT0-3N0M0 CRC without adjuvant chemotherapy). The primary endpoint is the 3-years disease-free survival after surgery. Secondary endpoints evaluate long-term clinical outcomes, in particular overall survival and side effect of 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

Primary outcome measures

  • disease free survival [Time frame: 3years]
Secondary outcome measures (5)
  • overall survival [Time frame: 5years]
  • adverse reaction of adjuvant therapies [Time frame: 3years]
  • remission rate of adjuvant therapies [Time frame: 1year]
  • death rate within 30 days post surgery [Time frame: 30days]
  • complication in 30 days post surgery [Time frame: 30days]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT03748485 · L2018ZSLYEC-162

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗