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Rectal CancerPhase 3COLORIINCT00297791

COLOR II: Laparoscopic Versus Open Rectal Cancer Removal

A Phase 3 study testing surgery in people with Rectal Cancer, run by Nova Scotia Health Authority at 35 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

COLOR II is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of rectal carcinoma below 15 cm with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Halifax, Canada. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer
What is being tested?
surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,044 participants
Where
35 sitesin 9 countries
Study dates
Jun 2004to Sep 2015
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

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

35 sites in 9 countries.

35 sites in 9 countries

Denmark7 sites

  • Aalborg Hospital

    Aalborg

  • SVS Esbjerg

    Esbjerg

  • Amtssygehus i Gentofte

    Gentofte Municipality

  • Hilleröd Hospital

    Hilleröd

  • Odense Universitetshospital

    Odense

  • Roskilde Hospital

    Roskilde

  • Viborg

    Viborg

Other trials in Denmark

Netherlands7 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch

  • Academisch Medisch Centrum

    Amsterdam

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam

  • VU Medisch Centrum

    Amsterdam

  • Rijnland Ziekenhuis

    Leiderdorp

  • Erasmus Medical Centre

    Rotterdam

  • Medisch Centrum Rijnmond-Zuid

    Rotterdam

Other trials in Netherlands

Germany5 sites

  • Ludwig-Maximilians Universität Klinikum Großhadern

    München

  • Caritas-Krankenhaus St. Josef

    Regensburg

  • University Hospital Regensburg

    Regensburg

  • Marienhospital

    Stuttgart

  • Wuerzburg University

    Würzburg

Other trials in Germany

Spain5 sites

  • Hospital Clinic i Provencial de Barcelona

    Barcelona

  • Hospital de Sant Pau

    Barcelona

  • Hospital S.A.S. de Jerez

    Cadiz

  • Hospital del Sureste de Madrid

    Madrid

  • Arrixaca Hospital Universitario

    Murcia

Other trials in Spain

Sweden5 sites

  • Sahlgrenska University Hospital

    Gothenburg

  • Örebro Hospital

    Örebro

  • Kärnsjukhuset

    Skvöde

  • Ersta Hospital

    Stockholm

  • Uddevalla Hospital

    Uddevalla

Other trials in Sweden

Canada3 sites

  • Royal Alexandra Hospital, University of Alberta

    Edmonton, Alberta

  • CDHA/ Dalhousie University

    Halifax, Nova Scotia, B3H 2Y9

  • University of Western Ontario

    London, Ontario

Other trials in Canada

Belgium1 site

  • Universitair Ziekenjuis Leuven

    Leuven

Other trials in Belgium

Poland1 site

  • Jagiellonian University

    Krakow

Other trials in Poland

South Korea1 site

  • Korea University Anam Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.

COLOR II is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of rectal carcinoma below 15 cm with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Halifax, Canada. Quality of life and costs will be assessed on a national basis.

Read the detailed description

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.

Conditions
Rectal Cancer
Being tested
surgery
Keywords
rectal cancer, laparoscopic technique, open technique, clinical trial, multicenter study, randomized controlled trial, Tumor Below 15cm, curative surgical resection, no evidence for distant metastases
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • surgeryProcedure or surgery

    Also called observation following intervention

    randomized to open or laparoscopic technique

Study groups in NCT00297791
Study groupRoleWhat they receive
1Othersurgery (open or laparoscopic) and observation
Receives: Procedure: surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. locoregional recurrence rate

    Measured: 3 years post operatively

Secondary outcomes (11)

  1. survival free of cancer recurrence

    Measured: three, five and seven years post-operatively

  2. overall survival

    Measured: three, five and seven years post-operatively

  3. port-site and wound-site recurrences

    Measured: annually for seven years

  4. distant metastases rate

    Measured: annually for seven years

  5. operative mortality and morbidity

    Measured: 8 week or in-hospital

  6. macroscopic evaluation of the resected specimen

    Measured: post-operative

  7. duration of in-hospital stay

    Measured: post-operative

  8. duration of absence of work

    Measured: 8 weeks and 6 months post-operatively

  9. postoperative health related quality of life,including standardized questionnaires on sexual and bladder function

    Measured: weekly for 8 weeks

  10. in-hospital direct and indirect costs

    Measured: seven years

  11. out-of-hospital postoperative costs

    Measured: seven years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2006 (estimated)
  2. Study startJun 2004
  3. Primary completionApr 2013
  4. Study completionSep 2015

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,044 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00297791
Sponsor's protocol ID
CDHA007
Acronym
COLORII
Status last verified
Jul 2013
First submitted
27 Feb 2006
Last updated
21 Aug 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Andersson J, Angenete E, Gellerstedt M, Haglind E. Developing a multivariable prediction model of global health-related quality of life in patients treated for rectal cancer: a prospective study in five countries. Int J Colorectal Dis. 2024 Mar 5;39(1):35. doi: 10.1007/s00384-024-04605-y.

    PubMed 38441657

  • Koedam TWA, Bootsma BT, Deijen CL, van de Brug T, Kazemier G, Cuesta MA, Furst A, Lacy AM, Haglind E, Tuynman JB, Daams F, Bonjer HJ; on behalf of the COLOR COLOR II study group. Oncological Outcomes After Anastomotic Leakage After Surgery for Colon or Rectal Cancer: Increased Risk of Local Recurrence. Ann Surg. 2022 Feb 1;275(2):e420-e427. doi: 10.1097/SLA.0000000000003889.

    PubMed 32224742

  • Petersson J, Koedam TW, Bonjer HJ, Andersson J, Angenete E, Bock D, Cuesta MA, Deijen CL, Furst A, Lacy AM, Rosenberg J, Haglind E; COlorectal cancer Laparoscopic or Open Resection (COLOR) II Study Group. Bowel Obstruction and Ventral Hernia After Laparoscopic Versus Open Surgery for Rectal Cancer in A Randomized Trial (COLOR II). Ann Surg. 2019 Jan;269(1):53-57. doi: 10.1097/SLA.0000000000002790.

    PubMed 29746337

  • Bonjer HJ, Deijen CL, Abis GA, Cuesta MA, van der Pas MH, de Lange-de Klerk ES, Lacy AM, Bemelman WA, Andersson J, Angenete E, Rosenberg J, Fuerst A, Haglind E; COLOR II Study Group. A randomized trial of laparoscopic versus open surgery for rectal cancer. N Engl J Med. 2015 Apr 2;372(14):1324-32. doi: 10.1056/NEJMoa1414882.

    PubMed 25830422

  • Andersson J, Abis G, Gellerstedt M, Angenete E, Angeras U, Cuesta MA, Jess P, Rosenberg J, Bonjer HJ, Haglind E. Patient-reported genitourinary dysfunction after laparoscopic and open rectal cancer surgery in a randomized trial (COLOR II). Br J Surg. 2014 Sep;101(10):1272-9. doi: 10.1002/bjs.9550. Epub 2014 Jun 12.

    PubMed 24924798

  • Andersson J, Angenete E, Gellerstedt M, Angeras U, Jess P, Rosenberg J, Furst A, Bonjer J, Haglind E. Health-related quality of life after laparoscopic and open surgery for rectal cancer in a randomized trial. Br J Surg. 2013 Jun;100(7):941-9. doi: 10.1002/bjs.9144.

    PubMed 23640671

  • van der Pas MH, Haglind E, Cuesta MA, Furst A, Lacy AM, Hop WC, Bonjer HJ; COlorectal cancer Laparoscopic or Open Resection II (COLOR II) Study Group. Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncol. 2013 Mar;14(3):210-8. doi: 10.1016/S1470-2045(13)70016-0. Epub 2013 Feb 6.

    PubMed 23395398

  • Color II Study Group; Buunen M, Bonjer HJ, Hop WC, Haglind E, Kurlberg G, Rosenberg J, Lacy AM, Cuesta MA, D'Hoore A, Furst A, Lange JF, Jess P, Bulut O, Poornoroozy P, Jensen KJ, Christensen MM, Lundhus E, Ovesen H, Birch D, Iesalnieks I, Jager C, Kreis M, van riet Y, van der Harst E, Gerhards MF, Bemelman WA, Hansson BM, Neijenhuis PA, Prins HA, Balague C, Targarona E, Lujan Mompean JA, Franco Osorio JD, Garcia Molina FJ, Skullman S, Lackberg Z, Kressner U, Matthiessen P, Kim SH, Poza AA. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer. Dan Med Bull. 2009 May;56(2):89-91.

    PubMed 19486621

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing surgery in people with Rectal Cancer, run by Nova Scotia Health Authority at 35 sites in 9 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 5 inclusion and 13 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 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Denmark, Netherlands, Germany, Spain, Sweden and 4 more countries. 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?

locoregional recurrence rate (time frame: 3 years post operatively). 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 NCT00297791, which also lists 8 linked publications.

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 21 Aug 2024.

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