Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma
20 Years
75 Years
Both
Rectal Cancer
Trial Information
Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma
Recently reported randomized controlled trials demonstrated that laparoscopic surgery was
comparable or superior to open surgery regarding the long-term outcome for colon and
rectosigmoidal carcinoma; however, controversy persists regarding the appropriateness of
laparoscopic surgery for patients with rectal carcinoma because of the uncertainty of the
long-term outcome, and of concerns over the safety of the procedure. In Japan, lateral lymph
node dissection combined with total mesorectal excision remains the standard surgical
procedure for patients with advanced lower rectal carcinoma, and lateral lymph node
dissection by laparoscopy is still an unexplored frontier. To examine the technical and
oncological feasibility of laparoscopic surgery for rectal carcinoma, a phase II trial will
be conducted in patients with a preoperative diagnosis of stage 0/I rectal carcinoma, under
the direction of the Japan Society of Laparoscopic Colorectal Surgery, to which leading
hospitals in laparoscopic surgery for colorectal carcinoma in Japan are members.
Inclusion Criteria:
1. Histologically proven rectal carcinoma.
2. Tumor located in the rectum.
3. Clinical Tis, T1, T2 N0 M0
4. Without multiple lesions other than carcinoma in situ
5. Tumor size <8 cm.
6. Sufficient organ function.
7. No bowel obstruction.
8. No history of major colorectal surgery.
9. No history of chemotherapy or radiotherapy.
10. Provide written informed consent.
Exclusion Criteria:
1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
2. Pregnant or lactating women.
3. Severe mental disease.
4. Severe pulmonary emphysema, interstitial pneumonitis or ischemic heart disease.
5. Continuous systemic steroid therapy.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
overall survival
Outcome Time Frame:
5 year
Safety Issue:
Yes
Principal Investigator
Masahiko Watanabe, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Kitasato University Hospital
Authority:
Japan: Japan Clinical Oncology Group
Study ID:
Lap RC
NCT ID:
NCT00635466
Start Date:
February 2008
Completion Date:
September 2015
Related Keywords:
- Rectal Cancer
- laparoscopic surgery, rectal carcinoma, phase II trial
- Carcinoma
- Rectal Neoplasms
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