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

• Status: Recruiting
• Trial end date: 2026-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

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.