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

Recruiting now · Not applicable

Conditions studied: Colorectal Cancer, Adjuvant Chemotherapy

In brief

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.

Key facts

Study ID

NCT03748485

Run by

Sixth Affiliated Hospital, Sun Yat-sen University

People needed

650

Starts

2019-04-30

Expected to finish

2030-12-30

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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