Colorectal CancerPhase 3NCT00007930
Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer
A Phase 3 study testing conventional surgery and laparoscopic surgery in people with Colorectal Cancer, run by National Medical Research Council (NMRC), Singapore at 3 sites in 2 countries.
Trial summary
RATIONALE: Surgery to remove the tumor may be an effective treatment for rectal cancer. It is not yet known whether one type of surgery is more effective than another for rectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two types of surgery in treating patients who have rectal cancer. 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?
- conventional surgery and laparoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 1999to 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:
- Clinical diagnosis of rectal cancer by colonoscopy or barium enema
- Distal margin of tumor arises within 9-15 cm from the anal verge as measured by rigid sigmoidoscopy
- No synchronous multiple adenocarcinomas
- Candidate for low anterior surgical resection by laparoscopy or conventional open method
- No evidence of gross metastatic disease
- No evidence of peritoneal or pelvic metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Not specified
Life expectancy:
- At least 6 months
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other malignancy within the past 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Neoadjuvant or adjuvant chemoradiotherapy allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- See Chemotherapy
Surgery:
- See Disease Characteristics
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
China2 sites, 2 recruiting
- Recruiting
Hong Kong Sanatorium & Hospital
Hong Kong
Samuel P.Y. Kwok, MD, 852-2899-2217, samuelpykwok@gmail.com
- Recruiting
Pamela Youde Nethersole Eastern Hospital
Hong Kong
Michael K.W. Li, FRCS, FHKAM, 852-2595-6389, mkwli@ha.org.hk
Singapore1 site, 1 recruiting
- Recruiting
National Cancer Centre - Singapore
Singapore, 169608
Heah Sieu Min, MD, 65-6526-5247
About this study
Official title: Randomized Trial of Wide Mesorectal Excision Versus Total Mesorectal Excision for Mid Rectal Cancer
RATIONALE: Surgery to remove the tumor may be an effective treatment for rectal cancer. It is not yet known whether one type of surgery is more effective than another for rectal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two types of surgery in treating patients who have rectal cancer.
Read the detailed description
OBJECTIVES:
- Compare local and distant recurrences in patients with mid-rectal cancer treated with wide mesorectal surgical excision with straight colorectal anastomosis versus total mesorectal surgical excision with colonic J pouch coloanal anastomosis.
- Compare the functional, physiological, and anatomical outcomes in these patients treated with these two surgical procedures.
- Compare disease-free survival and overall survival in these patients treated with these two surgical procedures.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to treatment center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo surgical resection with a wide mesorectal excision followed by a straight colorectal anastomosis.
- Arm II: Patients undergo surgical resection with a total mesorectal excision followed by a colonic J pouch coloanal anastomosis. Patients then receive a temporary ileostomy which is closed 6 weeks later.
Patients are followed at 6 weeks, every 4-6 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A minimum of 800 patients (400 per arm) will be accrued for this study.
- Conditions
- Colorectal Cancer
- Being tested
- conventional surgery, laparoscopic surgery
- Keywords
- stage I rectal cancer, stage II rectal cancer, stage III 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.
conventional surgeryProcedure or surgery
laparoscopic surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence at 3 years
Secondary outcomes (1)
Disease-free and overall survival at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 1999
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.
- 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
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Council (NMRC), Singapore
- Sponsor type
- Other government
- Investigators
- Heah Sieu Min, MD, Study chair, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00007930
- Sponsor's protocol ID
- CDR0000068354
- Other IDs
- NMRC-ICR01, EU-99019
- Status last verified
- Dec 2006
- First submitted
- 6 Jan 2001
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Wide Mesorectal Excision Versus Total Mesorectal Excision for Mid Rectal Cancer
- ClinicalTrials.gov ID
- NCT00007930
- Acronym / sponsor ID
- CDR0000068354
- Conditions
- Colorectal Cancer
- Keywords
- stage I rectal cancer, stage II rectal cancer, stage III rectal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- National Medical Research Council (NMRC), SingaporeOther government
- Study start
- Aug 1999
- First posted
- 27 Jan 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: Surgery to remove the tumor may be an effective treatment for rectal cancer. It is not yet known whether one type of surgery is more effective than another for rectal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two types of surgery in treating patients who have rectal cancer.
Detailed description
OBJECTIVES:
- Compare local and distant recurrences in patients with mid-rectal cancer treated with wide mesorectal surgical excision with straight colorectal anastomosis versus total mesorectal surgical excision with colonic J pouch coloanal anastomosis.
- Compare the functional, physiological, and anatomical outcomes in these patients treated with these two surgical procedures.
- Compare disease-free survival and overall survival in these patients treated with these two surgical procedures.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to treatment center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo surgical resection with a wide mesorectal excision followed by a straight colorectal anastomosis.
- Arm II: Patients undergo surgical resection with a total mesorectal excision followed by a colonic J pouch coloanal anastomosis. Patients then receive a temporary ileostomy which is closed 6 weeks later.
Patients are followed at 6 weeks, every 4-6 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A minimum of 800 patients (400 per arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
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 | – |
| laparoscopic surgery | Procedure or surgery | – |
Primary outcome
Local recurrence at 3 years
1 secondary outcome
Disease-free and overall survival at 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 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.
Heah Sieu Min, MD study chair
National Cancer Centre, Singapore
3 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 conventional surgery and laparoscopic surgery in people with Colorectal Cancer, run by National Medical Research Council (NMRC), Singapore at 3 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?
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 26 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 3 sites in China, Singapore. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence at 3 years. 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 26 Aug 2013.