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

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ClinicalTrials.gov Identifier: NCT02015923
Recruitment Status : Recruiting
First Posted : December 19, 2013
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Sebastiano Biondo, 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%).


Condition or disease Intervention/treatment Phase
Colonic Cancer Unresectable Metastasis Originating in Colonic Cancer Procedure: Colonic resection Drug: Chemotherapy- scheme Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Study Start Date : December 2013
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: colonic resection
Arm A (experimental): surgery (complete tumoral resection; R0) followed by chemotherapy, regimen according to each center.
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

Active Comparator: Chemotherapy
Arm B (control): chemotherapy alone, regimen according to each center
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


  2. 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.

  3. Quality of life [ Time Frame: up to 2 years ]
    Questionnaire QLQ-C30 (Quality of life) and QLQ-CR29

  4. 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; ...)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02015923


Contacts
Contact: Sebastiano Biondo, Principal investigator 0034932607485 sbn.biondo@gmail.com
Contact: Ricardo Frago, associate investigator 0034932607485 rfrago@bellvitgehospital.cat

Locations
Spain
Hospital Universitario Araba Active, not recruiting
Vitoria/Gasteiz, Araba, Spain
Hospital Universitari Germans Trias i Pujol Active, not recruiting
Badalona, Barcelona, Spain
Hospital Universitari de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08709
Contact: Sebastiano Biondo, Principal investigator    0034932607485    sbn.biondo@gmail.com   
Contact: Ricardo Frago, associate investigator    0034932607485    rfrago@bellvitgehospital.cat   
Principal Investigator: Sebastiano Biondo         
Sub-Investigator: Ricardo Frago         
Corporació Sanitària Parc Taulí Active, not recruiting
Sabadell, Barcelona, Spain
Hospital Moisès Broggi Active, not recruiting
Sant Joan Despí, Barcelona, Spain
Complejo Hospitalario La Mancha Centro Not yet recruiting
Alcazar de San Juan, Ciudad Real, Spain
Contact: Carlos Moreno Sanz         
Principal Investigator: Carlos Moreno Sanz         
Complejo Hospitalario de Navarra Not yet recruiting
Pamplona, Navarra, Spain
Contact: Miguel Ángel Ciga         
Principal Investigator: Miguel Ángel Ciga         
Complejo Hospitalario Universitario de Vigo Not yet recruiting
Vigo, Pontevedra, Spain
Contact: Teresa García Martínez         
Principal Investigator: Teresa García Martínez         
Complejo Hospitalario Torrecárdenas Not yet recruiting
Almería, Spain
Contact: Manuel Ferrer Márquez         
Principal Investigator: Manuel Ferrer Márquez         
Hospital de la Santa Creu i Sant Pau Not yet recruiting
Barcelona, Spain
Contact: Eduardo Targarona Soler         
Principal Investigator: Eduardo Targarona Soler         
Hospital del Mar Active, not recruiting
Barcelona, Spain
Hospital Univesitari Vall d'Hebron Active, not recruiting
Barcelona, Spain
Hospital Universitario Donostia Not yet recruiting
Donostia, Spain
Contact: José Máría Enríquez Navascués         
Principal Investigator: José Máría Enríquez Navascués         
Hospital Universitari de Girona DrJosep Trueta Not yet recruiting
Girona, Spain
Contact: David Julià Bergkvist         
Principal Investigator: David Julià Bergkvist         
Hospital Univerisitario La Paz Not yet recruiting
Madrid, Spain
Contact: Marío Álvarez Gallego         
Principal Investigator: Mario Álvarez Gallego         
Hospital Clínico Universitario Virgen de la Arrixaca Active, not recruiting
Murcia, Spain
Complejo Hospitalario Universitario de Orense Recruiting
Ourense, Spain
Contact: Alberto Parajó Calvo         
Principal Investigator: Alberto Parajo Calvo         
Hospital Universitario Virgen del Rocío Not yet recruiting
Sevilla, Spain
Contact: Fernando de la Portilla de Juan         
Principal Investigator: Fernando de la Portilla de Juan         
Hospital Clínico Universitario de Valencia Not yet recruiting
Valencia, Spain
Contact: Alejandro Espí Macias         
Principal Investigator: Alejandro Espí Macias         
Hospital General de Valencia Not yet recruiting
Valencia, Spain
Contact: Juan García Armengol         
Principal Investigator: Juan García Armengol         
Hospital Universitari i Politècnic la Fe Not yet recruiting
Valencia, Spain
Contact: Javier Vaqué         
Principal Investigator: Javier Vaqué         
Hospital Clínico Univeristario "Lozano Blesa" Not yet recruiting
Zaragoza, Spain
Contact: José Manuel Ramírez Rodríguez         
Principal Investigator: José Manuel Ramírez Rodríguez         
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Instituto de Salud Carlos III
Investigators
Study Chair: Sebastiano Biondo, Sponsor Hospital Universitari de Bellvitge
Principal Investigator: Javier Vaqué Hospital Universitario La Fe
Principal Investigator: Juan García Armengol Hospital General 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sebastiano Biondo, Phd, MD, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT02015923     History of Changes
Other Study ID Numbers: 01CCRe-IV
2013-001688-22 ( EudraCT Number )
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

Keywords provided by Sebastiano Biondo, Hospital Universitari de Bellvitge:
Colonic cancer
Metastasis

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes