Resection vs no Resection of the Primary in Colorectal Cancer With Unresectable Metastases
NCT ID: NCT02015923
Last Updated: 2021-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
107 participants
INTERVENTIONAL
2013-12-31
2020-02-29
Brief Summary
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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%).
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Detailed Description
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Differences between groups will be analyzed by t, U, X2, exact test and survival will be assessed according to Kaplan and Meier method. Evaluation of safety of the trial will be made in the middle of the study statistically
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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colonic resection
Arm A (experimental): surgery (complete tumoral resection; R0) followed by chemotherapy, regimen according to each center.
Colonic resection
Colonic cancer resection, R0 No surgical intervention on metastasis
Chemotherapy- scheme
Chemotherapy, specified in each center with or without biological drugs
Chemotherapy
Arm B (control): chemotherapy alone, regimen according to each center
Colonic resection
Colonic cancer resection, R0 No surgical intervention on metastasis
Chemotherapy- scheme
Chemotherapy, specified in each center with or without biological drugs
Interventions
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Colonic resection
Colonic cancer resection, R0 No surgical intervention on metastasis
Chemotherapy- scheme
Chemotherapy, specified in each center with or without biological drugs
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* unresectable synchronous metastases
* no contraindications for chemotherapy
* absence of peritoneal carcinomatosis, central nervous system o bone metastasis.
* performance status ECOG ≤ 2 (Eastern Cooperative Oncology Group)
* uncontrolled concomitant medical conditions that may compromise to chemotherapy
* significant symptomatic cardiac disease
* not pregnancy or breastfeeding
Exclusion Criteria
* Multiple bone metastasis or central nervous system metastasis
* Other neoplastic disease in the 5 previous years, except squamous or basal cell skin carcinoma or cervical "in situ" carcinoma
* Significant heart disease (chronic congestive heart failure, symptomatic coronary disease) or myocardial infarction in the previous 6 months
* Peripheral neuropathy
* Patients who do not give informed consent
18 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Hospital Universitari de Bellvitge
OTHER
Responsible Party
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Sebastiano Biondo
Phd, MD
Principal Investigators
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Sebastiano Biondo, Sponsor
Role: STUDY_CHAIR
Hospital Universitari de Bellvitge
Javier Vaqué
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario La Fe
Juan García Armengol
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario de Valencia
Laura Mora
Role: PRINCIPAL_INVESTIGATOR
Corporacion Parc Tauli
Ignasi Camps Ausàs
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari Gemans Tiras i Pujol
Miguel Pera Román
Role: PRINCIPAL_INVESTIGATOR
Hospital Univesitari del Mar
Eduardo Targarona Soler
Role: PRINCIPAL_INVESTIGATOR
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lorenzo Viso Pons
Role: PRINCIPAL_INVESTIGATOR
Hospital de Sant Joan Despí Moisès Broggi
José Manuel Ramírez Rodríguez
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínico Univeristario "Lozano Blesa"
David Julià Bergkvist
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari de Girona DrJosep Trueta
Teresa García Martínez
Role: PRINCIPAL_INVESTIGATOR
Complejo Hospitalario Universitario de Vigo
Mario Álvarez Gallego
Role: PRINCIPAL_INVESTIGATOR
Hospital Univerisitario La Paz
José María Enríquez Navascués
Role: PRINCIPAL_INVESTIGATOR
Hospital Donostia
Fernando de la Portilla de Juan
Role: PRINCIPAL_INVESTIGATOR
Hospitales Universitarios Virgen del Rocío
Miguel Angel Ciga
Role: PRINCIPAL_INVESTIGATOR
Complejo Hospitalario de Navarra
Eloy Espín Basany
Role: PRINCIPAL_INVESTIGATOR
hospital Universitari de la Vall D'Hebron
Manuel Ferrer Márquez
Role: PRINCIPAL_INVESTIGATOR
Complejo Hospitalario Torrecárdenas
Jesús Abrisqueta Carrión
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Virgen de la Arrixaca
José Errasti Alustiza
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Araba
Alberto Parajó Calvo
Role: PRINCIPAL_INVESTIGATOR
Complejo Hospitalario Universitario de Orense
Carlos Moreno Sanz
Role: PRINCIPAL_INVESTIGATOR
Complejo Hospitalario La Mancha Centro
Alejando Espí Macías
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínico Universitario de Valencia
Ricard Frago Montanuy
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari de Bellvitge
Locations
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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, 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
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
Countries
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References
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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.
Other Identifiers
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2013-001688-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
01CCRe-IV
Identifier Type: -
Identifier Source: org_study_id
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