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Phase 2
18 Years
75 Years
Open (Enrolling)
Colorectal Cancer

Thank you

Trial Information

Inclusion Criteria:

- Informed consent

- Pathologically confirmed adenocarcinoma

- Pre-surgery image staging as (CT/MRI):T2-3,N0-2,M0,(TNM stage,AJCC,version of 2003)

- Single tumor locating at cecum, ascending colon, descending colon, sigmoid colon,
rectosigmoid junction, rectum(distance from anal verge more than 7cm)

- Tumor diameter less than 6cm

- Age 18-75 year

- ECOG 0-2

- Predicted survival longer than 6 months

- Normal liver, renal, bone marrow function: (GPT less than 2 ULN,total bilirubin less
than 1.5mg/dl,Cr less than 1.5 ULN,WBC more than 4×109/L,PLT more than 100×109/L)

- No previous history of gastrointestinal surgery

- No previous history of chemotherapy or radiotherapy

Exclusion criteria

- Severe and uncontrolled medical disease including unstable angina pectoris, cardiac
infarction and cerebral attack in 6 months

- Could not tolerant general anesthesia or surgery for other organ dis-function

- Allergy to chemotherapeutical agents in the protocol

- History of other malignant tumor within 5 years

- Severe mental disorder

- Continued systematic steroid therapy

- Woman during pregnancy or lactation

- Under study of other clinical trial

- No compliance of the protocol

- Discovery of distant metastasis during surgery

- Postsurgery stage of I or IV tumors

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease free survival rate

Outcome Time Frame:

3 year

Safety Issue:


Principal Investigator

zhongtao zhang, doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

beijing friendship hospital, department of general surgery


China: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

April 2016

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms