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Randomized Controlled Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer（JCOG 0404,CRC Surg-LAP/OPEN)


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

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Trial Information

Randomized Controlled Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer（JCOG 0404,CRC Surg-LAP/OPEN)


The benefits of laparoscopic surgery (LAP) in comparison to open surgery (OPEN) have been
suggested with respect to decreased morbidity, decreased pain, faster recovery, and shorter
hospital stay.1-4 However, the long-term survival of LAP for colorectal cancer is still
unclear, especially for advanced colorectal cancer requiring extended lymphadenectomy.
Thus, the investigators designed a study which investigates whether LAP is suitable for
advanced colorectal cancer with respect to survival and post-operative morbidity.


Inclusion Criteria:



1. Histologically proven colorectal carcinoma

2. Tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon

3. T3 or deeper lesion without involvement of other organs

4. Without multiple lesion other than carcinoma in situ

5. Cancer classified as N0-2 and M0, according to the TNM classification system

6. Tumor size < 8 cm

7. No bowel obstruction

8. Age 20 < and > 75 years

9. Sufficient organ function

10. No history of gastrointestinal surgery

11. No history of chemotherapy or radiotherapy

12. Provided written informed consent

Exclusion Criteria:

1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ

2. Severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease

3. Pregnant or lactating women

4. Severe mental disease

5. Continuous systemic steroid therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival

Outcome Time Frame:

During the study conduct

Safety Issue:

No

Principal Investigator

Seigo Kitano, MD, PhD,FACS

Investigator Role:

Study Chair

Investigator Affiliation:

Oita University

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

JCOG0404

NCT ID:

NCT00147134

Start Date:

November 2004

Completion Date:

March 2014

Related Keywords:

  • Colorectal Cancer
  • colorectal cancer
  • laparoscopic surgery
  • randomized controlled trial
  • oncological outcome
  • Colorectal Neoplasms

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