Resection vs no Resection of the Primary in Colorectal Cancer With Unresectable Metastases
- Conditions
- Colonic CancerUnresectable Metastasis Originating in Colonic Cancer
- Interventions
- Procedure: Colonic resectionDrug: Chemotherapy- scheme
- Registration Number
- NCT02015923
- Lead Sponsor
- Hospital Universitari de Bellvitge
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 107
- colorectal cancer above to 12 cm from the anal verge
- 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
- Cases of rectal tumours below 12cm from anal verge, or locally advanced tumours invading blood vessels, nerves or bone.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description colonic resection Colonic resection Arm A (experimental): surgery (complete tumoral resection; R0) followed by chemotherapy, regimen according to each center. colonic resection Chemotherapy- scheme Arm A (experimental): surgery (complete tumoral resection; R0) followed by chemotherapy, regimen according to each center. Chemotherapy Colonic resection Arm B (control): chemotherapy alone, regimen according to each center Chemotherapy Chemotherapy- scheme Arm B (control): chemotherapy alone, regimen according to each center
- Primary Outcome Measures
Name Time Method Assess the impact of overall survival in patients with unresectable metastatic colorectal cancer treated with chemotherapy alone vs surgery followed by chemotherapy. up to 2 years The percentage of patients who are still alive for follow-up at 2 years after randomization.
- Secondary Outcome Measures
Name Time Method Postoperative morbidity and mortality. 30 days postoperatively Postoperative complications were classified according to the Dindo-Clavien classification.
Mortality within 30 days after surgeryQuestionnaire Quality of life CR29 up to 2 years Specific questionnaire for colon cancer
Study of possible survival factors up to 2 years Identify factors that may influence patient survival before applying any treatment (demographics, clinicals and analitycal factors, tumor characteristics; ...)
Complications in patients treated with systemic chemotherapy up to 2 years The toxicity will be evaluated and documented according to the CTCAE version 4.0.
Trial Locations
- Locations (22)
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Moisès Broggi
🇪🇸Sant Joan Despí, Barcelona, Spain
Corporació Sanitària Parc Taulí
🇪🇸Sabadell, Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Univesitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Donostia
🇪🇸Donostia, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Complejo Hospitalario Universitario de Orense
🇪🇸Ourense, Spain
Hospital Universitari i Politècnic la Fe
🇪🇸Valencia, Spain
Hospital General de Valencia
🇪🇸Valencia, Spain
Hospital Univerisitario La Paz
🇪🇸Madrid, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Complejo Hospitalario Torrecárdenas
🇪🇸Almería, Spain
Hospital Clínico Univeristario "Lozano Blesa"
🇪🇸Zaragoza, Spain
Hospital Universitari de Girona DrJosep Trueta
🇪🇸Girona, Spain
Hospital Universitario Araba
🇪🇸Vitoria/Gasteiz, Araba, Spain
Hospital Universitari de Bellvitge
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Complejo Hospitalario La Mancha Centro
🇪🇸Alcazar de San Juan, Ciudad Real, Spain
Complejo Hospitalario Universitario de Vigo
🇪🇸Vigo, Pontevedra, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Spain