Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma

Rectal Cancer Clinical Trial

— Lap RC  

Official title:

Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00635466
• Other study ID #: Lap RC
• Secondary ID: NCCHCT19-49
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 6, 2008
• Last updated: June 15, 2011
• Start date: February 2008
• Est. completion date: September 2015

Study information

• Verified date: June 2011
• Source: Japan Society of Laparoscopic Colorectal Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Japan Clinical Oncology Group
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 495
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer

Intervention

Procedure:
• laparoscopic surgery for rectal carcinoma
Laparoscopic resection of the rectum with adequate lymphadenectomy is performed according to the General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus edited by the Japanese Society for Cancer of the Colon and Rectum. The extent of lymphadenectomy and site of ligation and division of the inferior mesenteric vessels were decided by the surgeon in charge. Pneumoperitoneal approaches are used to explore the abdomen, mobilize the left side colon, identify critical structures and ligate the vascular pedicle. Mobilization of the rectum, excision of the mesorectum, rectal transection, removal of the specimen, and reconstruction are performed by the pneumoperitoneal approach or the extracorporeal approach via a small incision (<8 cm).

Locations

Country	Name	City	State
Japan	Kitasato University Hospital	Sagamihara	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Japan Society of Laparoscopic Colorectal Surgery

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Yamamoto S, Yoshimura K, Konishi F, Watanabe M. Phase II trial to evaluate laparoscopic surgery for Stage 0/I rectal carcinoma. Jpn J Clin Oncol. 2008 Jul;38(7):497-500. doi: 10.1093/jjco/hyn054. Epub 2008 Jun 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		5 year	Yes
Secondary	anastomotic leakage rate		1 month	Yes

External Links

•   Click here for the information regarding the Japanese Society for Cancer of the Colon and Rectum (JSCCR).