Rectal Reconstruction in Treating Patients Who Are Undergoing Surgery for Rectal Cancer - Full Text View

Sponsored by:	Swiss Group for Clinical Cancer Research
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00238381

Purpose

RATIONALE: Rectal reconstruction after surgery to treat rectal cancer may help patients keep some of their bowel function. It is not yet known which method of rectal reconstruction is most effective after surgery.

PURPOSE: This randomized phase III trial is studying three different methods of rectal reconstruction to compare how well they work in treating patients who are undergoing surgery for rectal cancer.

Condition	Intervention	Phase
Colorectal Cancer	Procedure: conventional surgery Procedure: laparoscopic surgery	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized
Official Title:	Clinical Function After Total Mesorectal Excision and Rectal Replacement. A Prospective Randomized Trial Comparing Side-to-End Anastomosis, Colon-J-Pouch and Straight Coloanal Anastomosis

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Composite evacuation score at 12 months after total mesorectal excision [ Designated as safety issue: No ]

Secondary Outcome Measures:

Composite evacuation score at 6, 18, and 24 months after total mesorectal excision [ Designated as safety issue: No ]
Composite incontinence score at 6, 12, 18, and 24 months after total mesorectal excision [ Designated as safety issue: No ]
Quality of life by Functional Assessment of Cancer Therapy-Colorectal scale at 6, 12, 18, and 24 months after total mesorectal excision [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Estimated Enrollment:	282
Study Start Date:	July 2005
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Compare side-to-end anastomosis vs colon-J-pouch anastomosis vs straight coloanal anastomosis as rectal reconstruction techniques after total mesorectal excision, in terms of defecation quality (i.e., evacuation problems/fragmentation of stools) and frequency, in patients with rectal cancer.
Compare surgery-related mortality and morbidity in patients undergoing these procedures.

Secondary

Compare short- and mid-term quality of life in patients undergoing these procedures.
Compare clinical outcomes in patients undergoing these procedures.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, gender, distance of the distal tumor margin from the dentate line (> 5 cm vs ≤ 5 cm), age (< 70 vs ≥ 70), neoadjuvant chemoradiotherapy (yes vs no), and distant metastasis (M0 vs M1). Patients are randomized to 1 of 3 treatment arms.

Arm I: Patients undergo total mesorectal excision (TME) by standard methods or laparoscopically and side-to-end anastomosis rectal reconstruction.
Arm II: Patients undergo TME and colon-J-pouch anastomosis rectal reconstruction.
Arm III: Patients undergo TME and straight coloanal anastomosis rectal reconstruction.

Quality of life is assessed at baseline and at 6, 12, 18, and 24 months after surgery.

After completion of study treatment, patients are followed at 6, 12, 18, and 24 months.

PROJECTED ACCRUAL: A total of 282 patients (94 per treatment arm) will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma or adenoma of the rectum
- Any T, any N, any M
Planning to undergo mesorectal excision with an expected R0 resection
- Simultaneous resection of liver metastases allowed
Must have clinically normal function of the rectal sphincter muscles (i.e., no history of frequent fecal incontinence for liquid or solid stools)

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Able to read and speak German, French, or Italian
No histologically confirmed chronic inflammatory bowel disease
No contraindication to study surgery
Body mass index ≤ 35
No psychiatric, addictive, or other disorder that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Prior neoadjuvant chemoradiotherapy for this cancer allowed

Endocrine therapy

Not specified

Radiotherapy

See Chemotherapy
No concurrent postoperative adjuvant radiotherapy

Surgery

No prior surgery for rectal cancer
- Local excision within the past 2 months allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238381

Locations

Switzerland
Kantonsspital - Abteilung Onkologie	Recruiting
Basel, Switzerland, 4031
Contact: Christian T. Hamel 41-61-265-5075

Sponsors and Collaborators

Swiss Group for Clinical Cancer Research

Investigators

Study Chair:	Christian T. Hamel	Kantonsspital - Abteilung Onkologie
Investigator:	Walter R. Marti, MD	Universitaetsspital-Basel
Investigator:	Markus Zuber, MD	Kantonsspital Olten

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000446077, SWS-SAKK-40/04, EU-20528
Study First Received:	October 12, 2005
Last Updated:	July 21, 2009
ClinicalTrials.gov Identifier:	NCT00238381 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the rectum
stage 0 rectal cancer
stage I rectal cancer
stage II rectal cancer

stage III rectal cancer
stage IV rectal cancer
recurrent rectal cancer

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Rectal Neoplasm
Intestinal Diseases
Rectal Diseases

Recurrence
Intestinal Neoplasms
Digestive System Diseases
Rectal Cancer
Gastrointestinal Neoplasms
Adenocarcinoma
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms

Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009