Spots Global Cancer Trial Database for Resection vs no Resection of the Primary in Colorectal Cancer With Unresectable Metastases
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Trial Identification
Brief Title: Resection vs no Resection of the Primary in Colorectal Cancer With Unresectable Metastases
Official Title: 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
Study ID: NCT02015923
Study Description
Brief Summary: 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%).
Detailed Description: Intervention: Arm B (control): chemotherapy alone, regimen according to each center. Arm A (experimental): surgery (complete tumoral resection; R0) followed by chemotherapy, regimen according to each center. Statistical Analysis: A power analysis showed that to assure a significance level of 0,05 and a beta error 0.20. 168 patients are necessary in each arm. It has been estimated a loss rate of up to 10%. 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
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Alcazar de San Juan, Ciudad Real, Spain
Complejo Hospitalario de Navarra, Pamplona, Navarra, 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, , 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, Sevilla, , 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
Contact Details
Name: Sebastiano Biondo, Sponsor
Affiliation: Hospital Universitari de Bellvitge
Role: STUDY_CHAIR
Name: Javier Vaqué
Affiliation: Hospital Universitario La Fe
Role: PRINCIPAL_INVESTIGATOR
Name: Juan García Armengol
Affiliation: Hospital General Universitario de Valencia
Role: PRINCIPAL_INVESTIGATOR
Name: Laura Mora
Affiliation: Corporacion Parc Tauli
Role: PRINCIPAL_INVESTIGATOR
Name: Ignasi Camps Ausàs
Affiliation: Hospital Universitari Gemans Tiras i Pujol
Role: PRINCIPAL_INVESTIGATOR
Name: Miguel Pera Román
Affiliation: Hospital Univesitari del Mar
Role: PRINCIPAL_INVESTIGATOR
Name: Eduardo Targarona Soler
Affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Role: PRINCIPAL_INVESTIGATOR
Name: Lorenzo Viso Pons
Affiliation: Hospital de Sant Joan Despí Moisès Broggi
Role: PRINCIPAL_INVESTIGATOR
Name: José Manuel Ramírez Rodríguez
Affiliation: Hospital Clínico Univeristario "Lozano Blesa"
Role: PRINCIPAL_INVESTIGATOR
Name: David Julià Bergkvist
Affiliation: Hospital Universitari de Girona DrJosep Trueta
Role: PRINCIPAL_INVESTIGATOR
Name: Teresa García Martínez
Affiliation: Complejo Hospitalario Universitario de Vigo
Role: PRINCIPAL_INVESTIGATOR
Name: Mario Álvarez Gallego
Affiliation: Hospital Univerisitario La Paz
Role: PRINCIPAL_INVESTIGATOR
Name: José María Enríquez Navascués
Affiliation: Hospital Universitario Donostia
Role: PRINCIPAL_INVESTIGATOR
Name: Fernando de la Portilla de Juan
Affiliation: Hospitales Universitarios Virgen del Rocío
Role: PRINCIPAL_INVESTIGATOR
Name: Miguel Angel Ciga
Affiliation: Complejo Hospitalario de Navarra
Role: PRINCIPAL_INVESTIGATOR
Name: Eloy Espín Basany
Affiliation: hospital Universitari de la Vall D'Hebron
Role: PRINCIPAL_INVESTIGATOR
Name: Manuel Ferrer Márquez
Affiliation: Complejo Hospitalario Torrecárdenas
Role: PRINCIPAL_INVESTIGATOR
Name: Jesús Abrisqueta Carrión
Affiliation: Hospital Clínico Universitario Virgen de la Arrixaca
Role: PRINCIPAL_INVESTIGATOR
Name: José Errasti Alustiza
Affiliation: Hospital Universitario Araba
Role: PRINCIPAL_INVESTIGATOR
Name: Alberto Parajó Calvo
Affiliation: Complejo Hospitalario Universitario de Orense
Role: PRINCIPAL_INVESTIGATOR
Name: Carlos Moreno Sanz
Affiliation: Complejo Hospitalario La Mancha Centro
Role: PRINCIPAL_INVESTIGATOR
Name: Alejando Espí Macías
Affiliation: Hospital Clínico Universitario de Valencia
Role: PRINCIPAL_INVESTIGATOR
Name: Ricard Frago Montanuy
Affiliation: Hospital Universitari de Bellvitge
Role: PRINCIPAL_INVESTIGATOR
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