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

RECRUITINGN/ASponsored by Sixth Affiliated Hospital, Sun Yat-sen University
Actively Recruiting
PhaseN/A
SponsorSixth Affiliated Hospital, Sun Yat-sen University
Started2019-04-30
Est. completion2027-12-30
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted

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

Age: 18 Years – 75 YearsHealthy volunteers accepted
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.

Conditions3

Adjuvant ChemotherapyCancerColorectal Cancer

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