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Trial record 1 of 1 for:    CELL (Colectomy for cancer in the Elderly by Laparoscopy or Laparotomy)
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Colectomy for Cancer in the Elderly by Laparoscopy or Laparotomy (CELL)

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ClinicalTrials.gov Identifier: NCT03033719
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The purpose of this study is to compare the postoperative global morbidity between patients who have been operated on for a colon cancer by laparotomy and those operated on by laparoscopy

Condition or disease Intervention/treatment Phase
Colonic Cancer Procedure: Laparotomy Procedure: Laparoscopy Not Applicable

Detailed Description:
The present study is a national, multicenter, open-label randomized, 2-arm superiority trial. Patients aged 75 years or older with uncomplicated colonic cancer or precancerous colonic lesion non-endoscopically resectable, will be randomized to either colectomy by laparoscopy or laparotomy. All patients that might be included will have a comprehensive geriatric assessment performed within the 30 days before randomization with the following scores: MMS (Mini Mental Score), ADL scale (Activities of Daily Living), IADL scale (Instrumental Activities of Daily Living), GDS (Geriatric Depression Scale) and TGUG test ("Timed Get-Up-and-Go" test).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Trial Comparing Laparoscopy and Laparotomy for Colon Cancer Surgery in Patients Older Than 75 Years
Actual Study Start Date : July 4, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Active Comparator: Laparotomy
Open surgery
Procedure: Laparotomy
Open surgery
Other Name: Open surgery

Experimental: Laparoscopy
Minimally invasive surgery
Procedure: Laparoscopy
Minimally invasive surgery
Other Name: Minimally invasive surgery




Primary Outcome Measures :
  1. Global postoperative morbidity in both arms [ Time Frame: At 30 days after the surgery ]
    Postoperative morbidity is defined as any surgical or medical complications occurring up to 30 days after surgery. It will be collected using a standardized collection form during hospitalization and eventual subsequent consultations in case of patient discharge before then


Secondary Outcome Measures :
  1. Postoperative mortality [ Time Frame: Evaluated at 30 days and at 90 days after the surgery ]
    Death from any cause

  2. Rate of readmission [ Time Frame: Within the 30 days after discharge of the patient ]
    Defined as any rehospitalization whatever the cause

  3. Number of examined lymph nodes [ Time Frame: At surgery ]
    Quality of surgical resection : Number of examined lymph nodes

  4. Type of resection (R0 or R1) [ Time Frame: At surgery ]
    Quality of surgical resection : Type of resection (R0 or R1)

  5. Pathological evaluation of mesocolic resection quality [ Time Frame: At surgery ]
    Quality of surgical resection : Pathological evaluation of mesocolic resection quality

  6. Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30) [ Time Frame: At randomization and three months postoperatively ]
    Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30)

  7. Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29) [ Time Frame: At randomization and three months postoperatively ]
    Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)

  8. Mini Mental State (MMS) Examination or Folstein test [ Time Frame: Before randomization and three months postoperatively ]
    Evolution of geriatric scores : The Mini Mental State (MMS) Examination or Folstein test; (Comprehensive geriatric assessment performed by a geriatrician on each site)

  9. Katz Activities of Daily Living (ADL) scale [ Time Frame: Before randomization and three months postoperatively ]
    Evolution of geriatric scores :The Katz Activities of Daily Living (ADL) scale (Comprehensive geriatric assessment performed by a geriatrician on each site)

  10. Geriatric Depression Scale (GDS) [ Time Frame: Before randomization and three months postoperatively ]
    Evolution of geriatric scores :The Geriatric Depression Scale (GDS) (Comprehensive geriatric assessment performed by a geriatrician on each site)

  11. Timed Get-up-and-go (TGUG) [ Time Frame: Before randomization and three months postoperatively ]
    Evolution of geriatric scores :The Timed Get-up-and-go (TGUG) test (Comprehensive geriatric assessment performed by a geriatrician on each site)


Other Outcome Measures:
  1. To establish a specific molecular classification of colon cancer in the elderly from expression chips [ Time Frame: within the 15 years after the tumor sampling ]
    To establish a specific molecular classification of colon cancer in the elderly from expression chips (Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort)

  2. To establish associations between molecular subtypes, the clinical and histological factors and relevant genetic alterations [ Time Frame: within the 15 years after the tumor sampling ]
    To establish associations between molecular subtypes, the clinical and histological factors and relevant genetic alterations (Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort)

  3. To establish a possible link between these molecular subtypes and overall survival of patients [ Time Frame: within the 15 years after the tumor sampling ]

    To establish a possible link between these molecular subtypes and overall survival of patients.

    (Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort)


  4. To compare our molecular classification with the different classifications already published in the literature on colorectal cance [ Time Frame: within the 15 years after the tumor sampling ]
    To compare our molecular classification with the different classifications already published in the literature on colorectal cancer (Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort)



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 75 years
  2. Histologically proven colonic adenocarcinoma (> 15 cm from the anal margin) or precancerous colonic lesion non endoscopically resectable
  3. Uncomplicated colonic tumor (no preoperative suspicion of invasion of adjacent structures as assessed by CT-scan (cT4), no tumoral perforation, or tumoral obstruction, or abscess, or hemorrhage)
  4. No previous colonic cancer within the 5 last years
  5. No peritoneal carcinosis on CT-scan
  6. Patient able to fill in an auto-questionnaire alone or with some help
  7. MMS (Mini Mental Score) ≥ 15
  8. Given oral consent (formal informed consent is not required by French law for accepted procedures)

Exclusion Criteria:

  1. Rectal cancer (≤ 15 cm from the anal margin)
  2. Locally advanced (cT4) or complicated tumor requiring extended resection or emergency surgery
  3. Synchronous colonic cancer
  4. - Scheduled need for synchronous intra-abdominal surgery, including surgery for liver metastases
  5. Absolute contraindications to general anesthesia or prolonged pneumoperitoneum
  6. Patient not able to tolerate colon surgery according to the global comprehensive geriatric assessment
  7. Estimated life expectancy less than 6 months
  8. Patient under guardianship
  9. Other known active cancer (except nonmelanomatous skin cancer)
  10. Patient not affiliated to the social security system
  11. Previous colonic resection

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): NCT03033719


Contacts
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Contact: Gilles MANCEAU, M.D., PhD., 00331 42 17 56 51 gilles.manceau@aphp.fr

Locations
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France
Groupe Hospitalier Pitié Salpêtrière Recruiting
Paris, France, 75013
Contact: Gilles MANCEAU, MD       gilles.manceau@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Gilles MANCEAU, M.D., PhD., Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03033719     History of Changes
Other Study ID Numbers: K130901
2016-A00312-49 ( Other Identifier: ID RCB )
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Colorectal Surgery
Geriatrics
Digestive Oncology
Colon cancer
Elderly patients
Laparoscopy
Laparotomy
Morbidity
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases