NCT00070005

Brief Summary

RATIONALE: A coloanal anastomosis may be effective in restoring bowel function after radiation therapy and surgery to remove the rectum. It is not yet known whether a J-pouch coloanal anastomosis is more effective than a side-to-end coloanal anastomosis in restoring bowel function in patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum. PURPOSE: This randomized phase III trial is studying how well J-pouch coloanal anastomosis works compared to side-to-end coloanal anastomosis in treating patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at below P25 for phase_3 colorectal-cancer

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2003

Completed
Last Updated

August 7, 2013

Status Verified

April 1, 2007

First QC Date

October 3, 2003

Last Update Submit

August 6, 2013

Conditions

Colorectal CancerPerioperative/Postoperative Complications

Keywords

perioperative/postoperative complicationsstage I rectal cancerstage II rectal cancerstage III rectal canceradenocarcinoma of the rectum

Outcome Measures

Primary Outcomes (1)

  • Functional outcome as measured by a validated questionnaire

Secondary Outcomes (2)

  • Quality life as measured by a validated questionnaire

  • Anorectal function as assessed by anorectal manometry and barostat measurements

Interventions

conventional surgeryPROCEDURE
management of therapy complicationsPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the rectum * T2 or T3 disease * Disease located in the mid- or distal rectum * No evidence of metastatic disease * No preexisting grade III or IV incontinence * Completed preoperative radiotherapy (5 x 5 Gy) before study entry PATIENT CHARACTERISTICS: Age * Over 18 Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Working knowledge of the Dutch language PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * No prior radiotherapy to the pelvis Surgery * No prior colon resection * No prior anorectal surgery * No concurrent abdominoperineal resection

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

St. Lucas - Andreas Ziekenhuis

Amsterdam, 1091 AE, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Gelre Ziekenhuizen - Lokatie Lukas

Apeldoorn, 7300 DS, Netherlands

Location

Reinier de Graaf Group - Delft

Delft, 2625 AD, Netherlands

Location

Albert Schweitzerziekenhuis - Locatie Amstelwijck

Dordrecht NM, NL-3317, Netherlands

Location

Isala Klinieken - locatie Sophia

Zwolle, 8000 GK, Netherlands

Location

Isala Klinieken - locatie Weezenlanden

Zwolle, 8000 GK, Netherlands

Location

MeSH Terms

Conditions

Colorectal NeoplasmsPostoperative ComplicationsRectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Roel Bakx, MD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2003

First Posted

October 7, 2003

Study Start

June 1, 2002

Last Updated

August 7, 2013

Record last verified: 2007-04

Locations

NL(9)