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

Colonic Cancer Clinical Trial

— CCRe-IV  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02015923
• Other study ID #: 01CCRe-IV
• Secondary ID: 2013-001688-22
• Status: Terminated
• Phase: Phase 4
• Start date: December 2013
• Est. completion date: February 2020

Study information

• Verified date: March 2021
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%).

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 information / eligibility

• Status: Terminated
• Enrollment: 107
• Est. completion date: February 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Colonic Cancer
• Colonic Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Unresectable Metastasis Originating in Colonic Cancer

Intervention

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

Locations

Country	Name	City	State
Spain	Complejo Hospitalario La Mancha Centro	Alcazar de San Juan	Ciudad Real
Spain	Complejo Hospitalario Torrecárdenas	Almería
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
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 Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Univerisitario La Paz	Madrid
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia
Spain	Complejo Hospitalario Universitario de Orense	Ourense
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Corporació Sanitària Parc Taulí	Sabadell	Barcelona
Spain	Hospital Moisès Broggi	Sant Joan Despí	Barcelona
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	Complejo Hospitalario Universitario de Vigo	Vigo	Pontevedra
Spain	Hospital Universitario Araba	Vitoria/Gasteiz	Araba
Spain	Hospital Clínico Univeristario "Lozano Blesa"	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the impact of overall survival in patients with unresectable metastatic colorectal cancer treated with chemotherapy alone vs surgery followed by chemotherapy.	The percentage of patients who are still alive for follow-up at 2 years after randomization.	up to 2 years
Secondary	Postoperative morbidity and mortality.	Postoperative complications were classified according to the Dindo-Clavien classification.; Mortality within 30 days after surgery	30 days postoperatively
Secondary	Complications in patients treated with systemic chemotherapy	The toxicity will be evaluated and documented according to the CTCAE version 4.0.	up to 2 years
Secondary	Questionnaire Quality of life CR29	Specific questionnaire for colon cancer	up to 2 years
Secondary	Study of possible survival factors	Identify factors that may influence patient survival before applying any treatment (demographics, clinicals and analitycal factors, tumor characteristics; ...)	up to 2 years