Colectomy for Cancer in the Elderly by Laparoscopy or Laparotomy

Colonic Cancer Clinical Trial

— CELL  

Official title:

Multicenter Randomized Trial Comparing Laparoscopy and Laparotomy for Colon Cancer Surgery in Patients Older Than 75 Years

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03033719
• Other study ID #: K130901
• Secondary ID: 2016-A00312-49
• Status: Recruiting
• Phase: N/A
• First received: January 10, 2017
• Last updated: January 11, 2018
• Start date: July 4, 2017
• Est. completion date: June 2020

Study information

• Verified date: January 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Gilles MANCEAU, M.D., PhD.,
• Phone: 00331 42 17 56 51
• Email: gilles.manceau[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 276
• Est. completion date: June 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Cancer
• Colonic Neoplasms

Intervention

Procedure:
• Laparotomy
Open surgery
• Laparoscopy
Minimally invasive surgery

Locations

Country	Name	City	State
France	Groupe Hospitalier Pitié Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To establish a specific molecular classification of colon cancer in the elderly from expression chips	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)	within the 15 years after the tumor sampling
Other	To establish associations between molecular subtypes, the clinical and histological factors and relevant genetic alterations	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)	within the 15 years after the tumor sampling
Other	To establish a possible link between these molecular subtypes and overall survival of patients	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)	within the 15 years after the tumor sampling
Other	To compare our molecular classification with the different classifications already published in the literature on colorectal cance	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)	within the 15 years after the tumor sampling
Primary	Global postoperative morbidity in both arms	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	At 30 days after the surgery
Secondary	Postoperative mortality	Death from any cause	Evaluated at 30 days and at 90 days after the surgery
Secondary	Rate of readmission	Defined as any rehospitalization whatever the cause	Within the 30 days after discharge of the patient
Secondary	Number of examined lymph nodes	Quality of surgical resection : Number of examined lymph nodes	At surgery
Secondary	Type of resection (R0 or R1)	Quality of surgical resection : Type of resection (R0 or R1)	At surgery
Secondary	Pathological evaluation of mesocolic resection quality	Quality of surgical resection : Pathological evaluation of mesocolic resection quality	At surgery
Secondary	Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30)	Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30)	At randomization and three months postoperatively
Secondary	Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)	Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)	At randomization and three months postoperatively
Secondary	Mini Mental State (MMS) Examination or Folstein test	Evolution of geriatric scores : The Mini Mental State (MMS) Examination or Folstein test; (Comprehensive geriatric assessment performed by a geriatrician on each site)	Before randomization and three months postoperatively
Secondary	Katz Activities of Daily Living (ADL) scale	Evolution of geriatric scores :The Katz Activities of Daily Living (ADL) scale (Comprehensive geriatric assessment performed by a geriatrician on each site)	Before randomization and three months postoperatively
Secondary	Geriatric Depression Scale (GDS)	Evolution of geriatric scores :The Geriatric Depression Scale (GDS) (Comprehensive geriatric assessment performed by a geriatrician on each site)	Before randomization and three months postoperatively
Secondary	Timed Get-up-and-go (TGUG)	Evolution of geriatric scores :The Timed Get-up-and-go (TGUG) test (Comprehensive geriatric assessment performed by a geriatrician on each site)	Before randomization and three months postoperatively