Resection vs no Resection of the Primary in Colorectal Cancer With Unresectable Metastases

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%).

Conditions

• Colonic Cancer
• Unresectable Metastasis Originating in Colonic Cancer

Interventions

PROCEDURE

Colonic resection

Colonic cancer resection, R0 No surgical intervention on metastasis

DRUG

Chemotherapy- scheme

Chemotherapy, specified in each center with or without biological drugs

Sponsors & Collaborators

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• Hospital Universitari de Bellvitge

  lead OTHER

Principal Investigators

• 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

• 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

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-12-31

Primary Completion

2019-06-30

Completion

2020-02-29

Countries

• Spain

Study Locations