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Recruiting
NCT03748485
Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis
Conditions: Colorectal Cancer, Adjuvant Chemotherapy
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 650
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Location: Sixth Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong
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 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.
Source: ClinicalTrials.gov (NCT03748485). StuddyBuddy aggregates publicly available trial information.