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A Prospective,Single-center,Randomized,Controlled Phase III Clinical Study Comparing Efficacy and Safety of Intraoperative Chemotherapy With 5-Fluorouracil Plus Curative Resection Versus Surgery Alone for Patients With Colorectal Cancer


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

A Prospective,Single-center,Randomized,Controlled Phase III Clinical Study Comparing Efficacy and Safety of Intraoperative Chemotherapy With 5-Fluorouracil Plus Curative Resection Versus Surgery Alone for Patients With Colorectal Cancer


nil.


Inclusion Criteria:



- histologically confirmed as adenocarcinoma of colon and rectum

- age 18-75 years

- eligible for curative surgical resection

- performance score: ECOG 0-1

- normal blood cells counts: WBC ≥ 4.0×10*9/L，PLT ≥ 100×10*9/L

- normal blood chemistry test: ALT/AST ≤ 2.5 ULN, TBil ≤ 1.5 ULN, BUN ≤ 1.5 ULN,Cr ≤
1.5 ULN

- normal ECG

- no history of other malignant tumors

- no concomitant anti-cancer therapy

Exclusion Criteria:

- clinical bowel obstruction

- anticipated into another clinical trial within three months

- uncontrolled infection, serious internal medical diseases

- Pregnant or lactating women

- mentally abnormal patients

- patients known allergic to 5-FU

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

disease-free survival

Outcome Description:

3 years survival of recurrence-free, metastasisi-free, death-free after randomization.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

zhizhong pan, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Ethics Committee

Study ID:

SYSU 5010-2010016 IOCCRC

NCT ID:

NCT01465451

Start Date:

March 2011

Completion Date:

December 2019

Related Keywords:

  • Colorectal Cancer
  • colorectal cancer
  • curative resection
  • intra-operative chemotherapy
  • 5-fluorouracil
  • chemotherapy
  • Colorectal Neoplasms

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