COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

M Buunen; H J Bonjer; W C J Hop; E Haglind; G Kurlberg; J Rosenberg; A M Lacy; M A Cuesta; A D'Hoore; A Fürst; J F Lange; P Jess; O Bulut; P Poornoroozy; K Juul Jensen; M Mark Christensen; E Lundhus; H Ovesen; D Birch; I Iesalnieks; C Jäger; M Kreis; Y van riet; E van der Harst; M F Gerhards; W A Bemelman; B M E Hansson; P A Neijenhuis; H A Prins; C Balague; E Targarona; J A Luján Mompeán; J D Franco Osorio; F J Garcia Molina; S Skullman; Z Läckberg; U Kressner; P Matthiessen; S H Kim; A Alfredo Poza; M Buunen; H J Bonjer; W C J Hop; E Haglind; G Kurlberg; J Rosenberg; A M Lacy; M A Cuesta; A D'Hoore; A Fürst; Color II Study Group

COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

M Buunen, H J Bonjer, W C J Hop, E Haglind, G Kurlberg, J Rosenberg, A M Lacy, M A Cuesta, A D'Hoore, A Fürst, J F Lange, P Jess, O Bulut, P Poornoroozy, K Juul Jensen, M Mark Christensen, E Lundhus, H Ovesen, D Birch, I IesalnieksC Jäger, M Kreis, Y van riet, E van der Harst, M F Gerhards, W A Bemelman, B M E Hansson, P A Neijenhuis, H A Prins, C Balague, E Targarona, J A Luján Mompeán, J D Franco Osorio, F J Garcia Molina, S Skullman, Z Läckberg, U Kressner, P Matthiessen, S H Kim, A Alfredo Poza, M Buunen, H J Bonjer, W C J Hop, E Haglind, G Kurlberg, J Rosenberg, A M Lacy, M A Cuesta, A D'Hoore, A Fürst, Color II Study Group

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Abstract

INTRODUCTION: Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial. Trial design: Non-inferiority randomized clinical trial. METHODS: The COLOR II trial is an ongoing international randomized clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy analysis. RESULTS: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal in both treatment groups. Most tumors are located in the mid-rectum (41%). CONCLUSION: Laparoscopic surgery in the treatment of rectal cancer is feasible. The results and safety of laparoscopic surgery in the treatment of rectal cancer remain unknown, but are subject of interim analysis within the COLOR II trial. Completion of inclusion is expected by the end of 2009. Trial registration: Clinicaltrials.gov, identifier: NCT00297791 (www.clinicaltrials.gov).

Original language	English
Journal	Danish Medical Bulletin
Volume	56
Issue number	2
Pages (from-to)	89-91
Number of pages	2
ISSN	0907-8916
Publication status	Published - 2009

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Buunen, M., Bonjer, H. J., Hop, W. C. J., Haglind, E., Kurlberg, G., Rosenberg, J., Lacy, A. M., Cuesta, M. A., D'Hoore, A., Fürst, A., Lange, J. F., Jess, P., Bulut, O., Poornoroozy, P., Jensen, K. J., Christensen, M. M., Lundhus, E., Ovesen, H., Birch, D., ... Color II Study Group (2009). COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer. Danish Medical Bulletin, 56(2), 89-91.

Buunen, M, Bonjer, HJ, Hop, WCJ, Haglind, E, Kurlberg, G, Rosenberg, J, Lacy, AM, Cuesta, MA, D'Hoore, A, Fürst, A, Lange, JF, Jess, P, Bulut, O, Poornoroozy, P, Jensen, KJ, Christensen, MM, Lundhus, E, Ovesen, H, Birch, D, Iesalnieks, I, Jäger, C, Kreis, M, van riet, Y, van der Harst, E, Gerhards, MF, Bemelman, WA, Hansson, BME, Neijenhuis, PA, Prins, HA, Balague, C, Targarona, E, Luján Mompeán, JA, Franco Osorio, JD, Garcia Molina, FJ, Skullman, S, Läckberg, Z, Kressner, U, Matthiessen, P, Kim, SH, Poza, AA, Buunen, M, Bonjer, HJ, Hop, WCJ, Haglind, E, Kurlberg, G, Rosenberg, J, Lacy, AM, Cuesta, MA, D'Hoore, A, Fürst, A & Color II Study Group 2009, 'COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer', Danish Medical Bulletin, vol. 56, no. 2, pp. 89-91.

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title = "COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer",

abstract = "INTRODUCTION: Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial. Trial design: Non-inferiority randomized clinical trial. METHODS: The COLOR II trial is an ongoing international randomized clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy analysis. RESULTS: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal in both treatment groups. Most tumors are located in the mid-rectum (41%). CONCLUSION: Laparoscopic surgery in the treatment of rectal cancer is feasible. The results and safety of laparoscopic surgery in the treatment of rectal cancer remain unknown, but are subject of interim analysis within the COLOR II trial. Completion of inclusion is expected by the end of 2009. Trial registration: Clinicaltrials.gov, identifier: NCT00297791 (www.clinicaltrials.gov).",

author = "M Buunen and Bonjer, {H J} and Hop, {W C J} and E Haglind and G Kurlberg and J Rosenberg and Lacy, {A M} and Cuesta, {M A} and A D'Hoore and A F{\"u}rst and Lange, {J F} and P Jess and O Bulut and P Poornoroozy and Jensen, {K Juul} and Christensen, {M Mark} and E Lundhus and H Ovesen and D Birch and I Iesalnieks and C J{\"a}ger and M Kreis and {van riet}, Y and {van der Harst}, E and Gerhards, {M F} and Bemelman, {W A} and Hansson, {B M E} and Neijenhuis, {P A} and Prins, {H A} and C Balague and E Targarona and {Luj{\'a}n Mompe{\'a}n}, {J A} and {Franco Osorio}, {J D} and {Garcia Molina}, {F J} and S Skullman and Z L{\"a}ckberg and U Kressner and P Matthiessen and Kim, {S H} and Poza, {A Alfredo} and M Buunen and Bonjer, {H J} and Hop, {W C J} and E Haglind and G Kurlberg and J Rosenberg and Lacy, {A M} and Cuesta, {M A} and A D'Hoore and A F{\"u}rst and {Color II Study Group}",

note = "Keywords: Adult; Aged; Aged, 80 and over; Digestive System Surgical Procedures; Female; Humans; Laparoscopy; Male; Middle Aged; Neoplasm Recurrence, Local; Patient Selection; Rectal Neoplasms; Research Design",

year = "2009",

language = "English",

volume = "56",

pages = "89--91",

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AU - Buunen, M

AU - Bonjer, H J

AU - Hop, W C J

AU - Haglind, E

AU - Kurlberg, G

AU - Rosenberg, J

AU - Lacy, A M

AU - Cuesta, M A

AU - D'Hoore, A

AU - Fürst, A

AU - Lange, J F

AU - Jess, P

AU - Bulut, O

AU - Poornoroozy, P

AU - Jensen, K Juul

AU - Christensen, M Mark

AU - Lundhus, E

AU - Ovesen, H

AU - Birch, D

AU - Iesalnieks, I

AU - Jäger, C

AU - Kreis, M

AU - van riet, Y

AU - van der Harst, E

AU - Gerhards, M F

AU - Bemelman, W A

AU - Hansson, B M E

AU - Neijenhuis, P A

AU - Prins, H A

AU - Balague, C

AU - Targarona, E

AU - Luján Mompeán, J A

AU - Franco Osorio, J D

AU - Garcia Molina, F J

AU - Skullman, S

AU - Läckberg, Z

AU - Kressner, U

AU - Matthiessen, P

AU - Kim, S H

AU - Poza, A Alfredo

AU - Buunen, M

AU - Bonjer, H J

AU - Hop, W C J

AU - Haglind, E

AU - Kurlberg, G

AU - Rosenberg, J

AU - Lacy, A M

AU - Cuesta, M A

AU - D'Hoore, A

AU - Fürst, A

AU - Color II Study Group

N1 - Keywords: Adult; Aged; Aged, 80 and over; Digestive System Surgical Procedures; Female; Humans; Laparoscopy; Male; Middle Aged; Neoplasm Recurrence, Local; Patient Selection; Rectal Neoplasms; Research Design

PY - 2009

Y1 - 2009

N2 - INTRODUCTION: Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial. Trial design: Non-inferiority randomized clinical trial. METHODS: The COLOR II trial is an ongoing international randomized clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy analysis. RESULTS: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal in both treatment groups. Most tumors are located in the mid-rectum (41%). CONCLUSION: Laparoscopic surgery in the treatment of rectal cancer is feasible. The results and safety of laparoscopic surgery in the treatment of rectal cancer remain unknown, but are subject of interim analysis within the COLOR II trial. Completion of inclusion is expected by the end of 2009. Trial registration: Clinicaltrials.gov, identifier: NCT00297791 (www.clinicaltrials.gov).

AB - INTRODUCTION: Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial. Trial design: Non-inferiority randomized clinical trial. METHODS: The COLOR II trial is an ongoing international randomized clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy analysis. RESULTS: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal in both treatment groups. Most tumors are located in the mid-rectum (41%). CONCLUSION: Laparoscopic surgery in the treatment of rectal cancer is feasible. The results and safety of laparoscopic surgery in the treatment of rectal cancer remain unknown, but are subject of interim analysis within the COLOR II trial. Completion of inclusion is expected by the end of 2009. Trial registration: Clinicaltrials.gov, identifier: NCT00297791 (www.clinicaltrials.gov).

M3 - Journal article

SN - 2245-1919

VL - 56

SP - 89

EP - 91

JO - Danish Medical Journal

JF - Danish Medical Journal

IS - 2

ER -

COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

Abstract

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