Colorectal CancerPhase 3NCT00238381
Rectal Reconstruction in Treating Patients Who Are Undergoing Surgery for Rectal Cancer
A Phase 3 study testing 5 cm colon-J-pouch, side-to-end anastomosis and straight coloanal anastomosis in people with Colorectal Cancer, run by Swiss Cancer Institute at 18 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- 5 cm colon-J-pouch, side-to-end anastomosis and straight coloanal anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Jul 2005to Aug 2016
- 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
Who may be able to join
None listed.
Who cannot join
- Rectal tumor other than adenocarcinoma or adenoma
- Previous rectal cancer surgery, other than local excision within the last 2 months
- Histologically proven chronic inflammatory bowel disease
- Contraindications to any of the 3 surgical techniques
- BMI > 35
- Patients with psychiatric, addictive or any disorder that would prohibit the understanding and giving of informed consent, completing the QL questionnaires and/or following the structured interview
- Inability to read and understand any of the languages available on the QL questionnaires,and spoken during the interview (German, French, Italian)
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
Switzerland17 sites
Kantonsspital Aarau
Aarau, CH-5001
Zuger Kantonsspital AG
Baar, 6340
Universitaetsspital-Basel
Basel, CH-4031
Inselspital Bern
Bern, CH-3010
Kantonsspital Bruderholz
Bruderholz, CH-4101
Bezirksspital Dornach
Dornach, CH-4143
Hopitaux Universitaires de Geneve
Geneva, CH-1226
Hopital de La Chaux-de-Fonds
La Chaux-de-Fonds, CH 2300
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
Kantonsspital Luzern
Luzerne, CH-6000
Ospedale Beata Vergine
Mendrisio, CH-6850
Kantonsspital Olten
Olten, CH-4600
GZO Spital Wetzikon
Wetzikon, 8620
Kantonsspital Winterthur
Winterthur, CH-8400
Klinik Hirslanden
Zurich, CH-8032
City Hospital Triemli
Zurich, CH-8063
UniversitaetsSpital Zuerich
Zurich, CH-8091
About this study
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
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.
Read the detailed description
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.
- Conditions
- Colorectal Cancer
- Being tested
- 5 cm colon-J-pouch, side-to-end anastomosis, straight coloanal anastomosis
- Keywords
- 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
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 cm colon-J-pouchProcedure or surgery
5 cm colon-J-pouch with/without temporary protective ileostomy
side-to-end anastomosisProcedure or surgery
side-to-end anastomosis with/without temporary protective ileostomy
straight coloanal anastomosisProcedure or surgery
straight coloanal anastomosis with/without temporary protective ileostomy
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Other | Patients undergo total mesorectal excision (TME) by standard methods or laparoscopically and side-to-end anastomosis rectal reconstruction. Receives: Procedure: side-to-end anastomosis |
| Arm II | Other | Patients undergo TME and colon-J-pouch anastomosis rectal reconstruction. Receives: Procedure: 5 cm colon-J-pouch |
| Arm III | Other | Patients undergo straight coloanal anastomosis with/without temporary protective ileostomy Receives: Procedure: straight coloanal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite evacuation score after total mesorectal excision
Measured: 12 months after surgery
Secondary outcomes (5)
Composite evacuation score at 6, 18, and 24 months after total mesorectal excision
Measured: 6, 18 and 24 months after surgery
Composite incontinence score after total mesorectal excision
Measured: 6, 12, 18 and 24 months
Quality of life after total mesorectal excision
Measured: 6, 12m 18 and 24 months
Overall survival
Measured: 2 years follow-up
Morbidity
Measured: 2 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study startJul 2005
- Primary completionMay 2014
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian T. Hamel, MD, Study chair, Kantonsspital - Abteilung OnkologieWalter R. Marti, Prof., Study chair, Kantonsspital AarauMarkus Zuber, MD, Study chair, Kantonsspital Olten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238381
- Sponsor's protocol ID
- SAKK 40/04
- Other IDs
- EU-20528
- Status last verified
- May 2019
- First submitted
- 12 Oct 2005
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marti WR, Curti G, Wehrli H, Grieder F, Graf M, Gloor B, Zuber M, Demartines N, Fasolini F, Lerf B, Kettelhack C, Andrieu C, Bigler M, Hayoz S, Ribi K, Hamel C; Swiss Group for Clinical Cancer Research (SAKK), Section Surgery. Clinical Outcome After Rectal Replacement With Side-to-End, Colon-J-Pouch, or Straight Colorectal Anastomosis Following Total Mesorectal Excision: A Swiss Prospective, Randomized, Multicenter Trial (SAKK 40/04). Ann Surg. 2019 May;269(5):827-835. doi: 10.1097/SLA.0000000000003057.
PubMed 30252681
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00238381
- Acronym / sponsor ID
- SAKK 40/04
- Conditions
- Colorectal Cancer
- Keywords
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 Oct 2005 (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: 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I | Other | Procedure: side-to-end anastomosisPatients undergo total mesorectal excision (TME) by standard methods or laparoscopically and side-to-end anastomosis rectal reconstruction. |
| Arm II | Other | Procedure: 5 cm colon-J-pouchPatients undergo TME and colon-J-pouch anastomosis rectal reconstruction. |
| Arm III | Other | Procedure: straight coloanal anastomosisPatients undergo straight coloanal anastomosis with/without temporary protective ileostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Rectal tumor other than adenocarcinoma or adenoma
- Previous rectal cancer surgery, other than local excision within the last 2 months
- Histologically proven chronic inflammatory bowel disease
- Contraindications to any of the 3 surgical techniques
- BMI > 35
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 |
|---|---|---|
| 5 cm colon-J-pouch5 cm colon-J-pouch with/without temporary protective ileostomy | Procedure or surgery | Arm II |
| side-to-end anastomosisside-to-end anastomosis with/without temporary protective ileostomy | Procedure or surgery | Arm I |
| straight coloanal anastomosisstraight coloanal anastomosis with/without temporary protective ileostomy | Procedure or surgery | Arm III |
Primary outcome
Composite evacuation score after total mesorectal excision
Time frame: 12 months after surgery
5 secondary outcomes
Composite evacuation score at 6, 18, and 24 months after total mesorectal excision
Time frame: 6, 18 and 24 months after surgery
Composite incontinence score after total mesorectal excision
Time frame: 6, 12, 18 and 24 months
Quality of life after total mesorectal excision
Time frame: 6, 12m 18 and 24 months
Overall survival
Time frame: 2 years follow-up
Morbidity
Time frame: 2 years follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Results publication: PubMed 30252681Marti WR, Curti G, Wehrli H, Grieder F, Graf M, Gloor B, Zuber M, Demartines N, Fasolini F, Lerf B, Kettelhack C, Andrieu C, Bigler M, Hayoz S, Ribi K, Hamel C; Swiss Group for Clinical Cancer Research (SAKK), Section Surgery. Clinical Outcome After Rectal Replacement With Side-to-End, Colon-J-Pouch, or Straight Colorectal Anastomosis Following Total Mesorectal Excision: A Swiss Prospective, Randomized, Multicenter Trial (SAKK 40/04). Ann Surg. 2019 May;269(5):827-835. doi: 10.1097/SLA.0000000000003057.
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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.
Christian T. Hamel, MD study chair
Kantonsspital - Abteilung Onkologie
Walter R. Marti, Prof. study chair
Kantonsspital Aarau
Markus Zuber, MD study chair
Kantonsspital Olten
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5 cm colon-J-pouch, side-to-end anastomosis and straight coloanal anastomosis in people with Colorectal Cancer, run by Swiss Cancer Institute at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. 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: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Switzerland, Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite evacuation score after total mesorectal excision (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00238381, which also lists 1 linked publication.
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 15 May 2019.