Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Bevacizumab

Panitumumab

Antineoplastic Agents, Immunological

Cola

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

Colonic resection

Chemotherapy, specified in each center with or without biological drugs

Chemotherapy- scheme

Sebastiano Biondo, Sponsor

Javier Vaqué

Juan García Armengol

Laura Mora

Ignasi Camps Ausàs

Miguel Pera Román

Eduardo Targarona Soler

Lorenzo Viso Pons

José Manuel Ramírez Rodríguez

David Julià Bergkvist

Teresa García Martínez

Mario Álvarez Gallego

José María Enríquez Navascués

Fernando de la Portilla de Juan

Miguel Angel Ciga

Eloy Espín Basany

Manuel Ferrer Márquez

Jesús Abrisqueta Carrión

José Errasti Alustiza

Alberto Parajó Calvo

Carlos Moreno Sanz

Alejando Espí Macías

Ricard Frago Montanuy

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%).

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

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

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

The percentage of patients who are still alive for follow-up at 2 years after randomization.

Postoperative complications were classified according to the Dindo-Clavien classification.

Mortality within 30 days after surgery

The toxicity will be evaluated and documented according to the CTCAE version 4.0.

Identify factors that may influence patient survival before applying any treatment (demographics, clinicals and analitycal factors, tumor characteristics; ...)

Instituto de Salud Carlos III

Hospital Universitari de Bellvitge

Phd, MD

Spots Global Cancer Trial Database for unresectable metastasis originating in colonic cancer