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Trial record 4 of 1009 for:    colon cancer AND resection

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 : 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

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


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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
Actual Primary Completion Date : June 2017
Estimated Study Completion Date : February 2020

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; ...)



Information from the National Library of Medicine

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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


Locations
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Spain
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, Spain, 08709
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain
Hospital Moisès Broggi
Sant Joan Despí, Barcelona, Spain
Complejo Hospitalario La Mancha Centro
Alcazar de San Juan, Ciudad Real, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarra, 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, 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
Sevilla, 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
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Instituto de Salud Carlos III
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: September 17, 2019
Last Verified: September 2019
Keywords provided by Sebastiano Biondo, Hospital Universitari de Bellvitge:
Colonic cancer
Metastasis
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Neoplastic Processes
Pathologic Processes