Difficulties surrounding recruiting patients
CCRe-IV
Multicenter Randomized Study in Patients With Colorectal Cancer With Unresectable Metastases. Impact of Resection vs no Resection of the Primary Tumour as a Survival Factor
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
107
1 country
22
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2019
Actual (reported)Study Completion
February 2020
Actual (reported)Main outcome: Assess the impact of cancer-related survival at 2 years in patients with unresectable metastatic colorectal cancer treated with chemotherapy alone versus surgery followed by chemotherapy. To assess overall survival. To evaluate postoperative morbidity and mortality in patients treated with resection of the primary tumor. Assess complications and meed for surgery in patients treated with systemic chemotherapy only during the course of the disease. Identify and describe the complications related to chemotherapy and toxicity in the short and medium term systemic treatment. Assessing the quality of life questionnaire QLQ-C30 and QLQ-CR29. To study prognostic survival factors. Method: multicenter randomized clinical trail (22 hospitals). Two parallel group in which to evaluate two therapeutic strategies for colorectal cancer metastasis unresectable stage IV: chemotherapy alone versus primary tumor resection plus chemotherapy. Subjects: patients with unresectable nonmetastatic colorectal cancer. Hypothesis:Surgical resection of the primary tumor in stage IV colorectal patients with unresectable synchronous metastases increases by 14% overall survival compared to patients receiving systemic treatment with chemotherapy without resection of the primary tumor (survival of 34% vs 20%).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 28, 2013
Actual (reported)December 2013
Date type not reportedThis date has not been verified as actual or estimated.
December 19, 2013
Actual (reported)June 2019
Actual (reported)February 2020
Actual (reported)Assess the impact of overall survival in patients with unresectable metastatic colorectal cancer treated with chemotherapy alone vs surgery followed by chemotherapy.
The percentage of patients who are still alive for follow-up at 2 years after randomization.
up to 2 years
Postoperative morbidity and mortality.
30 days postoperatively
Complications in patients treated with systemic chemotherapy
up to 2 years
Questionnaire Quality of life CR29
up to 2 years
Study of possible survival factors
up to 2 years
Arm A (experimental): surgery (complete tumoral resection; R0) followed by chemotherapy, regimen according to each center.
Arm B (control): chemotherapy alone, regimen according to each center
Colonic cancer resection, R0 No surgical intervention on metastasis
Chemotherapy, specified in each center with or without biological drugs
Hospital Universitario Araba
Vitoria-Gasteiz, Araba, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08709, Spain
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain
Hospital Moisès Broggi
Sant Joan Despí, Barcelona, Spain
Complejo Hospitalario La Mancha Centro
Alcázar de San Juan, Ciudad Real, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Rahbari NN, Biondo S, Frago R, Feisst M, Kreisler E, Rossion I, Serrano M, Jager D, Lehmann M, Sommer F, Dignass A, Bolling C, Vogel I, Bork U, Buchler MW, Folprecht G, Kieser M, Lordick F, Weitz J; SYNCHRONOUS and CCRe-IV Trial Groups. Primary Tumor Resection Before Systemic Therapy in Patients With Colon Cancer and Unresectable Metastases: Combined Results of the SYNCHRONOUS and CCRe-IV Trials. J Clin Oncol. 2024 May 1;42(13):1531-1541. doi: 10.1200/JCO.23.01540. Epub 2024 Feb 27.
Biondo S, Frago R, Kreisler E, Espin-Basany E; Spanish CR4 Group. Impact of resection versus no resection of the primary tumor on survival in patients with colorectal cancer and synchronous unresectable metastases: protocol for a randomized multicenter study (CR4). Int J Colorectal Dis. 2017 Jul;32(7):1085-1090. doi: 10.1007/s00384-017-2827-3. Epub 2017 May 11.
Sebastiano Biondo, Sponsor
Hospital Universitari de Bellvitge
Javier Vaqué
Hospital Universitario La Fe
Juan García Armengol
Hospital General Universitario de Valencia
Laura Mora
Corporacion Parc Tauli
107 participants (actual enrollment reported by the registry).
First Submitted
November 28, 2013
First Posted
December 19, 2013
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Clinical Trial on HIPEC With Mitomycin C in Colon Cancer Peritoneal Metastases (GECOP-MMC)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Complejo Hospitalario Universitario de Vigo
Vigo, Pontevedra, Spain
Complejo Hospitalario Torrecárdenas
Almería, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Univesitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Spain
Hospital Universitari de Girona DrJosep Trueta
Girona, Spain
Hospital Univerisitario La Paz
Madrid, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
Complejo Hospitalario Universitario de Orense
Ourense, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Hospital General de Valencia
Valencia, Spain
Hospital Universitari i Politècnic la Fe
Valencia, Spain
Hospital Clínico Univeristario "Lozano Blesa"
Zaragoza, Spain
Ignasi Camps Ausàs
Hospital Universitari Gemans Tiras i Pujol
Miguel Pera Román
Hospital Univesitari del Mar
Eduardo Targarona Soler
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lorenzo Viso Pons
Hospital de Sant Joan Despí Moisès Broggi
José Manuel Ramírez Rodríguez
Hospital Clínico Univeristario "Lozano Blesa"
David Julià Bergkvist
Hospital Universitari de Girona DrJosep Trueta
Teresa García Martínez
Complejo Hospitalario Universitario de Vigo
Mario Álvarez Gallego
Hospital Univerisitario La Paz
José María Enríquez Navascués
Hospital Donostia
Fernando de la Portilla de Juan
Hospitales Universitarios Virgen del Rocío
Miguel Angel Ciga
Complejo Hospitalario de Navarra
Eloy Espín Basany
hospital Universitari de la Vall D'Hebron
Manuel Ferrer Márquez
Complejo Hospitalario Torrecárdenas
Jesús Abrisqueta Carrión
Hospital Universitario Virgen de la Arrixaca
José Errasti Alustiza
Hospital Universitario Araba
Alberto Parajó Calvo
Complejo Hospitalario Universitario de Orense
Carlos Moreno Sanz
Complejo Hospitalario La Mancha Centro
Alejando Espí Macías
Hospital Clínico Universitario de Valencia
Ricard Frago Montanuy
Hospital Universitari de Bellvitge
Primary Completion
June 2019
Actual (reported)Study Completion
February 2020
Actual (reported)Last Updated
March 16, 2021
Record last verified: 2021-03
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Source: ClinicalTrials.gov.
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