NCT03748485

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
57mo left

Started Apr 2019

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Apr 2019Dec 2030

First Submitted

Initial submission to the registry

November 15, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

April 30, 2019

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

8.7 years

First QC Date

November 15, 2018

Last Update Submit

January 26, 2026

Conditions

Colorectal CancerAdjuvant Chemotherapy

Keywords

local advanced colorectal canceradjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • disease free survival

    3years disease-free survival rate

    3years

Secondary Outcomes (5)

  • overall survival

    5years

  • adverse reaction of adjuvant therapies

    3years

  • remission rate of adjuvant therapies

    1year

  • death rate within 30 days post surgery

    30days

  • complication in 30 days post surgery

    30days

Study Arms (2)

wait and watch group

EXPERIMENTAL

clinical local advanced colorectal cancer (cTxN1/2M0) following pre-operational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0) without adjuvant chemotherapy

Behavioral: wait and watch

adjuvant chemotherapy group

ACTIVE COMPARATOR

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

Drug: adjuvant chemotherapy

Interventions

wait and watchBEHAVIORAL

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

wait and watch group
adjuvant chemotherapyDRUG

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

Also known as: mFOLFOX6
adjuvant chemotherapy group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Jianping Wang, MD/PHD

    sixth affiliate hospital of Sun yatsen Hospital

    STUDY CHAIR

Central Study Contacts

Jianping Wang, MD/PHD

CONTACT

+86 13808874808wangjpgz@126.com

Jun Huang, MD/PHD

CONTACT

+86 13926451242haungj97@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 15, 2018

First Posted

November 21, 2018

Study Start

April 30, 2019

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2030

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)