Study Stopped
Difficulties surrounding recruiting patients
Resection vs no Resection of the Primary in Colorectal Cancer With Unresectable Metastases
CCRe-IV
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
2 other identifiers
interventional
107
1 country
22
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%).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2013
Longer than P75 for phase_4
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedFirst Posted
Study publicly available on registry
December 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedMarch 16, 2021
March 1, 2021
5.5 years
November 28, 2013
March 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Postoperative morbidity and mortality.
30 days postoperatively
Complications in patients treated with systemic chemotherapy
up to 2 years
Questionnaire Quality of life CR29
up to 2 years
Study of possible survival factors
up to 2 years
Study Arms (2)
colonic resection
EXPERIMENTALArm A (experimental): surgery (complete tumoral resection; R0) followed by chemotherapy, regimen according to each center.
Chemotherapy
ACTIVE COMPARATORArm B (control): chemotherapy alone, regimen according to each center
Interventions
Colonic cancer resection, R0 No surgical intervention on metastasis
Chemotherapy, specified in each center with or without biological drugs
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Universitari de Bellvitgelead
- Instituto de Salud Carlos IIIcollaborator
Study Sites (22)
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, 08709, Spain
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain
Hospital Moisès Broggi
Sant Joan Despí, Barcelona, Spain
Complejo Hospitalario La Mancha Centro
Alcázar de San Juan, Ciudad Real, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, 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 / San Sebastian, 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
Seville, 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
Related Publications (2)
Rahbari NN, Biondo S, Frago R, Feisst M, Kreisler E, Rossion I, Serrano M, Jager D, Lehmann M, Sommer F, Dignass A, Bolling C, Vogel I, Bork U, Buchler MW, Folprecht G, Kieser M, Lordick F, Weitz J; SYNCHRONOUS and CCRe-IV Trial Groups. Primary Tumor Resection Before Systemic Therapy in Patients With Colon Cancer and Unresectable Metastases: Combined Results of the SYNCHRONOUS and CCRe-IV Trials. J Clin Oncol. 2024 May 1;42(13):1531-1541. doi: 10.1200/JCO.23.01540. Epub 2024 Feb 27.
PMID: 38412408DERIVEDBiondo S, Frago R, Kreisler E, Espin-Basany E; Spanish CR4 Group. Impact of resection versus no resection of the primary tumor on survival in patients with colorectal cancer and synchronous unresectable metastases: protocol for a randomized multicenter study (CR4). Int J Colorectal Dis. 2017 Jul;32(7):1085-1090. doi: 10.1007/s00384-017-2827-3. Epub 2017 May 11.
PMID: 28497402DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sebastiano Biondo, Sponsor
Hospital Universitari de Bellvitge
- PRINCIPAL INVESTIGATOR
Javier Vaqué
Hospital Universitario La Fe
- PRINCIPAL INVESTIGATOR
Juan García Armengol
Hospital General Universitario de Valencia
- PRINCIPAL INVESTIGATOR
Laura Mora
Corporacion Parc Tauli
- PRINCIPAL INVESTIGATOR
Ignasi Camps Ausàs
Hospital Universitari Gemans Tiras i Pujol
- PRINCIPAL INVESTIGATOR
Miguel Pera Román
Hospital Univesitari del Mar
- PRINCIPAL INVESTIGATOR
Eduardo Targarona Soler
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- PRINCIPAL INVESTIGATOR
Lorenzo Viso Pons
Hospital de Sant Joan Despí Moisès Broggi
- PRINCIPAL INVESTIGATOR
José Manuel Ramírez Rodríguez
Hospital Clínico Univeristario "Lozano Blesa"
- PRINCIPAL INVESTIGATOR
David Julià Bergkvist
Hospital Universitari de Girona DrJosep Trueta
- PRINCIPAL INVESTIGATOR
Teresa García Martínez
Complejo Hospitalario Universitario de Vigo
- PRINCIPAL INVESTIGATOR
Mario Álvarez Gallego
Hospital Univerisitario La Paz
- PRINCIPAL INVESTIGATOR
José María Enríquez Navascués
Hospital Donostia
- PRINCIPAL INVESTIGATOR
Fernando de la Portilla de Juan
Hospitales Universitarios Virgen del Rocío
- PRINCIPAL INVESTIGATOR
Miguel Angel Ciga
Complejo Hospitalario de Navarra
- PRINCIPAL INVESTIGATOR
Eloy Espín Basany
hospital Universitari de la Vall D'Hebron
- PRINCIPAL INVESTIGATOR
Manuel Ferrer Márquez
Complejo Hospitalario Torrecárdenas
- PRINCIPAL INVESTIGATOR
Jesús Abrisqueta Carrión
Hospital Universitario Virgen de la Arrixaca
- PRINCIPAL INVESTIGATOR
José Errasti Alustiza
Hospital Universitario Araba
- PRINCIPAL INVESTIGATOR
Alberto Parajó Calvo
Complejo Hospitalario Universitario de Orense
- PRINCIPAL INVESTIGATOR
Carlos Moreno Sanz
Complejo Hospitalario La Mancha Centro
- PRINCIPAL INVESTIGATOR
Alejando Espí Macías
Hospital Clínico Universitario de Valencia
- PRINCIPAL INVESTIGATOR
Ricard Frago Montanuy
Hospital Universitari de Bellvitge
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Phd, MD
Study Record Dates
First Submitted
November 28, 2013
First Posted
December 19, 2013
Study Start
December 1, 2013
Primary Completion
June 1, 2019
Study Completion
February 1, 2020
Last Updated
March 16, 2021
Record last verified: 2021-03