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Trial record 66 of 4084 for:    colon cancer AND Intestinal Neoplasms

Colectomy in Patients With Asymptomatic and Unresectable Stage IV Colon Cancer (CLIMAT)

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ClinicalTrials.gov Identifier: NCT02363049
Recruitment Status : Unknown
Verified February 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : February 13, 2015
Last Update Posted : February 23, 2017
Sponsor:
Collaborators:
UNICANCER
Federation Francophone de Cancerologie Digestive
GERCOR - Multidisciplinary Oncology Cooperative Group
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The present study is a multicentric randomized phase III trial designed to assess whether overall survival and quality of life are improved in patients with asymptomatic colon cancer and unresectable SLM treated with resection of the PT followed by chemotherapy versus chemotherapy alone.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm of Large Intestine Colon Cancer Liver Metastasis Procedure: Colectomy Drug: Chemotherapy Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase III Study Assessing the Interest of Primary Tumor Resection in Patients With Asymptomatic Colon Cancer and Unresectable Synchronous Liver Metastases.
Study Start Date : July 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: colectomy
surgery followed by chemotherapy +/- targeted therapy regime according to each centre
Procedure: Colectomy
Drug: Chemotherapy
Active Comparator: no colectomy
Chemotherapy +/- targeted therapy alone, regime according to each centre.
Drug: Chemotherapy



Primary Outcome Measures :
  1. overall survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. quality of life [ Time Frame: 2 years ]
    Questionnaire QLQ-C30 et QLQ-CR29 in both treatment arms Time frame : one month after surgery in arm A, one month after the beginning of chemotherapy in arm B and then each 3 months in both treatment arms up to 2 years

  2. Post-operative complications [ Time Frame: 30 days ]
    Post-operative complications (surgical or medical) will be graded according to the Clavien-Dindo system

  3. Progression free survival (PFS) [ Time Frame: 2 years ]

    PFS is defined as the time interval between the date of randomization and the first date of progression of the metastatic disease or death in both treatment arms.

    Time frame: each 3 months up to 2 years.


  4. Time to metastatic progression (TTP) [ Time Frame: 2 years ]
    TTP is defined as the time interval between the date of randomization and the first date of progression of the metastatic disease or death in both treatment arms in both treatment arms Time frame: each 3 months up to 2 years.

  5. Rate of secondary curative resection (R0) [ Time Frame: 1 year ]
    The rate of secondary curative resection will be assessed in both treatment arms and will concern resection of both the PT and the metastatic disease Time frame: each 3 months up to 12 months



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Pathologically confirmed colon adenocarcinoma (≥ 15 cm from the anal verge)
  • Uncomplicated PT (obstruction, bleeding, abcess, perforation)
  • No known unresectable PT on CT/MRI scan.
  • Unresectable synchronous liver metastases
  • No extra-hepatic metastatic disease
  • Age ≥ 18 years et ≤ 75 years
  • ECOG performance status 0-1
  • Life expectancy without cancer >2 years
  • No prior chemotherapy in the past 5 years
  • No prior abdominal or pelvic irradiation
  • No history of colorectal cancer in the past 5years
  • Patients with childbearing potential should use effective contraception during the study and the following 6 months
  • White blood cell count ≥ 3 x 109/L with neutrophils ≥ 1.5 x 109/L, platelet count ≥ 100 x109/L, hemoglobin ≥ 9 g/dL (5,6 mmol/l)
  • Total bilirubin <1.5 x ULN (upper limit of normal), ASAT and ALAT<2.5 x ULN, Alkaline phosphatase<1.5 x ULN, Serum creatinine < 1.5 x ULN
  • Signed written informed consent obtained prior to any study specific screening procedures

Exclusion criteria :

  • Resectable or potentially resectable liver metastases
  • Complicated (obstruction, bleeding, abcess, perforation) or non resectable PT
  • Rectal cancer located within 15 cm from the anal verge by endoscopy or under the peritoneal reflection at surgery or having received radiation therapy prior to surgery
  • Age > 75 years
  • ECOG performance status > 2
  • Denutrition (albumin < 30 g/l)
  • Synchronous colorectal cancer
  • Extrahepatic metastatic disease
  • Known hypersensitivity reaction or specific contraindications to any of the components of study treatments
  • History of anti-EGFR or anti-VEGF treatment within the past 5 years
  • History or current evidence on physical examination of central nervous system disease or
  • peripheral neuropathy ≥ grade 1 Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0
  • Presence of inflammatory bowel disease
  • HNPCC syndrome or polyposis
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start. Incompletely healed wounds or anticipation of the need for major surgical procedure during the course of the study
  • Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
  • Pregnancy (absence to be confirmed by ß-hCG test) or breast-feeding period
  • Previous malignancy in the last 5 years
  • Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
  • Any significant disease which, in the investigator's opinion, would exclude the patient from the study

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): NCT02363049


Contacts
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Contact: Mehdi Karoui, MD, PhD +331-42-17-56-51

Locations
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France
Groupe hospitalier Pitié Salpetriere Recruiting
Paris, France, 75013
Contact: Mehdi Karoui, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
UNICANCER
Federation Francophone de Cancerologie Digestive
GERCOR - Multidisciplinary Oncology Cooperative Group
Investigators
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Principal Investigator: Mehdi Karoui, MD, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02363049     History of Changes
Other Study ID Numbers: 2013-A00685-40
First Posted: February 13, 2015    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Colectomy
primary tumor resection
Asymptomatic primary colon cancer
Unresectable synchronous liver metastasis
TNM Staging Primary Tumor (T)
Unresectable

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