COLOR II: Laparoscopic Versus Open Rectal Cancer Removal (COLORII)
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| ClinicalTrials.gov Identifier: NCT00297791 |
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Recruitment Status : Unknown
Verified July 2013 by Jaap Bonjer, Nova Scotia Health Authority.
Recruitment status was: Active, not recruiting
First Posted : March 1, 2006
Last Update Posted : July 30, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rectal Cancer | Procedure: surgery | Phase 3 |
The design involves allocation of all suitable consecutive patients with rectal carcinoma to either of the two procedures at a randomization ratio of 2:1 in favor of the laparoscopic procedure. Excluded are patients with a carcinoma treated by local resection and palliative resections. The trial will be stratified according to participating centre, resection type, and preoperative radiotherapy.
If the 95% CI for the difference of the 3-year locoregional recurrence rates excludes a difference greater than 5% in favor of the conventional procedure, non-inferiority of the laparoscopic procedure will be concluded. Assuming both rates are 10%, 1000 evaluable cases are required in total for a power of 80%.
Analysis will be primarily on an intention to treat basis. Definition of conversion is defined by protocol.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer. |
| Study Start Date : | June 2004 |
| Actual Primary Completion Date : | April 2013 |
| Estimated Study Completion Date : | October 2017 |
| Arm | Intervention/treatment |
|---|---|
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1
surgery (open or laparoscopic) and observation
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Procedure: surgery
randomized to open or laparoscopic technique
Other Name: observation following intervention |
- locoregional recurrence rate [ Time Frame: 3 years post operatively ]
- survival free of cancer recurrence [ Time Frame: three, five and seven years post-operatively ]
- overall survival [ Time Frame: three, five and seven years post-operatively ]
- port-site and wound-site recurrences [ Time Frame: annually for seven years ]
- distant metastases rate [ Time Frame: annually for seven years ]
- operative mortality and morbidity [ Time Frame: 8 week or in-hospital ]
- macroscopic evaluation of the resected specimen [ Time Frame: post-operative ]
- duration of in-hospital stay [ Time Frame: post-operative ]
- duration of absence of work [ Time Frame: 8 weeks and 6 months post-operatively ]
- postoperative health related quality of life,including standardized questionnaires on sexual and bladder function [ Time Frame: weekly for 8 weeks ]
- in-hospital direct and indirect costs [ Time Frame: seven years ]
- out-of-hospital postoperative costs [ Time Frame: seven years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- solitary rectal cancer observed at colonoscopy or on barium X-ray
- no evidence of distant metastases
- distal border of the tumor within 15 cm of the anal verge at rigid rectoscopy or under linea conjugata at lateral barium enema radiography
- suitable for elective surgical resection
- informed consent
Exclusion Criteria:
- T1 tumors treated by locl excision
- T4 tumors
- patients under 18 years of age
- signs of acute intestinal obstruction
- more than one colorectal tumor
- Familial Adenomatosis Polyposis, Hereditary Non-Polyposis Colorectal Cancer
- active crohn's or active ulcerative colitis
- scheduled need for other synchronous colon surgery
- preoperative indication of invasion of adjacent organs, immobile at palpation or CT showing invasion
- preoperative evidence of metastases (at least chest X-ray and liver ultrasound)
- other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
- absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class > III)
- pregnancy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00297791
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| Principal Investigator: | Jaap Bonjer, MD, PhD | Dalhousie University, and VUMC, the Netherlands | |
| Principal Investigator: | Marius Hoogerboord | Nova Scotia Health Authority |
| Responsible Party: | Jaap Bonjer, MD, PhD, Nova Scotia Health Authority |
| ClinicalTrials.gov Identifier: | NCT00297791 |
| Other Study ID Numbers: |
CDHA007 |
| First Posted: | March 1, 2006 Key Record Dates |
| Last Update Posted: | July 30, 2013 |
| Last Verified: | July 2013 |
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rectal cancer laparoscopic technique open technique clinical trial multicenter study |
randomized controlled trial Tumor Below 15cm curative surgical resection no evidence for distant metastases |
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Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |