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
Sixth Affiliated Hospital, Sun Yat-sen University
650 participants
Apr 30, 2019
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
Inclusion Criteria4
- 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 Criteria10
- 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.
Interventions
clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0),without(wait and watch) adjuvant chemotherapy
clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0),with adjuvant chemotherapy
Locations(1)
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NCT03748485