Colorectal CancerPhase 3NCT00070005
J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma
A Phase 3 study testing conventional surgery and management of therapy complications in people with Colorectal Cancer and Perioperative/Postoperative Complications, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 9 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Perioperative/Postoperative Complications
- What is being tested?
- conventional surgery and management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 9 sitesNetherlands
- Study dates
- Jun 2002to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Netherlands9 sites
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, 1066 CX
St. Lucas - Andreas Ziekenhuis
Amsterdam, 1091 AE
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 HA
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, 1105 AZ
Gelre Ziekenhuizen - Lokatie Lukas
Apeldoorn, 7300 DS
Reinier de Graaf Group - Delft
Delft, 2625 AD
Albert Schweitzerziekenhuis - Locatie Amstelwijck
Dordrecht NM, NL-3317
Isala Klinieken - locatie Sophia
Zwolle, 8000 GK
Isala Klinieken - locatie Weezenlanden
Zwolle, 8000 GK
About this study
Official title: A Phase III Randomised Study Of J-Pouch Coloanal Anastomosis Versus Side-To-End Coloanal Anastomosis After Preoperative Radiotherapy And Total Mesorectal Excision In Patients With Mid And Distal Rectal Cancer
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.
Read the detailed description
OBJECTIVES:
Primary
- Compare functional outcome in patients with mid- or distal rectal adenocarcinoma when treated with J-pouch coloanal anastomosis vs side-to-end coloanal anastomosis after preoperative radiotherapy and total mesorectal excision.
Secondary
- Compare the quality of life of patients treated with these procedures.
- Compare anorectal function in patients treated with these procedures.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and gender. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo total mesorectal excision followed by a J-pouch coloanal anastomosis.
- Arm II: Patients undergo total mesorectal excision followed by a side-to-end coloanal anastomosis.
In both arms, patients receive a temporary ileostomy. The ileostomy is closed after 1 week provided recovery is uneventful and no radiological signs of anastomotic leakage are detected. If early closure is not possible, the ileostomy is closed after 6-8 weeks.
Functional outcome, quality of life, and anorectal function are assessed before surgery and at 4 and 12 months after surgery.
PROJECTED ACCRUAL: A minimum of 100 patients (50 per treatment arm) will be accrued for this study.
- Being tested
- conventional surgery, management of therapy complications
- Keywords
- perioperative/postoperative complications, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, adenocarcinoma of the rectum
- Medical subject headings
- Colorectal Neoplasms, Postoperative Complications, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional surgeryProcedure or surgery
management of therapy complicationsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2003 (estimated)
- Study startJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Roel Bakx, MD, Study chair, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070005
- Sponsor's protocol ID
- CKTO-2002-02-POCASTER
- Other IDs
- CDR0000328269, EU-20247
- Status last verified
- Apr 2007
- First submitted
- 3 Oct 2003
- Last updated
- 7 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomised Study Of J-Pouch Coloanal Anastomosis Versus Side-To-End Coloanal Anastomosis After Preoperative Radiotherapy And Total Mesorectal Excision In Patients With Mid And Distal Rectal Cancer
- ClinicalTrials.gov ID
- NCT00070005
- Acronym / sponsor ID
- CKTO-2002-02-POCASTER
- Keywords
- perioperative/postoperative complications, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, adenocarcinoma of the rectum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Jun 2002
- First posted
- 7 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- Compare functional outcome in patients with mid- or distal rectal adenocarcinoma when treated with J-pouch coloanal anastomosis vs side-to-end coloanal anastomosis after preoperative radiotherapy and total mesorectal excision.
Secondary
- Compare the quality of life of patients treated with these procedures.
- Compare anorectal function in patients treated with these procedures.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and gender. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo total mesorectal excision followed by a J-pouch coloanal anastomosis.
- Arm II: Patients undergo total mesorectal excision followed by a side-to-end coloanal anastomosis.
In both arms, patients receive a temporary ileostomy. The ileostomy is closed after 1 week provided recovery is uneventful and no radiological signs of anastomotic leakage are detected. If early closure is not possible, the ileostomy is closed after 6-8 weeks.
Functional outcome, quality of life, and anorectal function are assessed before surgery and at 4 and 12 months after surgery.
PROJECTED ACCRUAL: A minimum of 100 patients (50 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional surgery | Procedure or surgery | – |
| management of therapy complications | Procedure or surgery | – |
Primary outcome
Functional outcome as measured by a validated questionnaire
2 secondary outcomes
Quality life as measured by a validated questionnaire
Anorectal function as assessed by anorectal manometry and barostat measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roel Bakx, MD study chair
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing conventional surgery and management of therapy complications in people with Colorectal Cancer and Perioperative/Postoperative Complications, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 9 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome as measured by a validated questionnaire. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.