Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Resection vs no Resection of the Primary in Colorectal Cancer With Unresectable Metastases (CCRe-IV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02015923
Recruitment Status : Active, not recruiting
First Posted : December 19, 2013
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Sebastiano Biondo, Hospital Universitari de Bellvitge

Tracking Information
First Submitted Date  ICMJE November 28, 2013
First Posted Date  ICMJE December 19, 2013
Last Update Posted Date September 17, 2019
Study Start Date  ICMJE December 2013
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2013)
Assess the impact of overall survival in patients with unresectable metastatic colorectal cancer treated with chemotherapy alone vs surgery followed by chemotherapy. [ Time Frame: up to 2 years ]
The percentage of patients who are still alive for follow-up at 2 years after randomization.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2013)
  • Postoperative morbidity and mortality. [ Time Frame: 30 days postoperatively ]
    Postoperative complications were classified according to the Dindo-Clavien classification. Mortality within 30 days after surgery
  • Complications in patients treated with systemic chemotherapy [ Time Frame: up to 2 years ]
    The toxicity will be evaluated and documented according to the CTCAE version 4.0.
  • Quality of life [ Time Frame: up to 2 years ]
    Questionnaire QLQ-C30 (Quality of life) and QLQ-CR29
  • Study of possible survival factors [ Time Frame: up to 2 years ]
    Identify factors that may influence patient survival before applying any treatment (demographics, clinicals and analitycal factors, tumor characteristics; ...)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Resection vs no Resection of the Primary in Colorectal Cancer With Unresectable Metastases
Official Title  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Colonic Cancer
  • Unresectable Metastasis Originating in Colonic Cancer
Intervention  ICMJE
  • 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
    Other Names:
    • FOLFOX-4
    • FOLFOX-6
    • FOLFIRI
    • FOLFOXIRI
    • CAPOX
    • CETUXIMAX / BEVACIZUMAB/PANITUMUMAB
Study Arms  ICMJE
  • Experimental: colonic resection
    Arm A (experimental): surgery (complete tumoral resection; R0) followed by chemotherapy, regimen according to each center.
    Interventions:
    • Procedure: Colonic resection
    • Drug: Chemotherapy- scheme
  • Active Comparator: Chemotherapy
    Arm B (control): chemotherapy alone, regimen according to each center
    Interventions:
    • Procedure: Colonic resection
    • Drug: Chemotherapy- scheme
Publications * Biondo 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 13, 2013)
336
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02015923
Other Study ID Numbers  ICMJE 01CCRe-IV
2013-001688-22 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sebastiano Biondo, Hospital Universitari de Bellvitge
Study Sponsor  ICMJE Hospital Universitari de Bellvitge
Collaborators  ICMJE Instituto de Salud Carlos III
Investigators  ICMJE
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 Universitario 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 Clínico 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
PRS Account Hospital Universitari de Bellvitge
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP