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

ConditionsColorectal CancerAdjuvant Chemotherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSixth Affiliated Hospital, Sun Yat-sen University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • wait and watch

    Behavioral

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

  • adjuvant chemotherapy

    Drug

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

Treatment groups

650 Participants
are divided into 2 treatment groups
Group A: wait and watch groupExperimental treatment 1 intervention
Group B: adjuvant chemotherapy groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

disease free survival

3years disease-free survival rate

Time frame
3years

Secondary outcomes

1

overall survival

5years overall survival rate

Time frame
5years
2

adverse reaction of adjuvant therapies

Rate of participants with myelosuppression, gastrointestinal reaction, infection, lose hair

Time frame
3years
3

remission rate of adjuvant therapies

CRC remission evaluation using RECIST after adjuvant therapies

Time frame
1year
4

death rate within 30 days post surgery

death related directly with operation within 30 days

Time frame
30days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sixth Affiliated Hospital, Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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