Clinical trial NCT03033719: Colectomy for Cancer in the Elderly by Laparoscopy or Laparotomy
Official title: Multicenter Randomized Trial Comparing Laparoscopy and Laparotomy for Colon Cancer Surgery in Patients Older Than 75 Years
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Cancer
Keywords: Colorectal Surgery
Geriatrics
Digestive Oncology
Colon cancer
Elderly patients
Laparoscopy
Laparotomy
Morbidity
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 276
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Eligibility 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

Primary outcomes:
measure: Global postoperative morbidity in both arms
timeFrame: At 30 days after the surgery
Secondary outcomes:
measure: Postoperative mortality
timeFrame: Evaluated at 30 days and at 90 days after the surgery
measure: Rate of readmission
timeFrame: Within the 30 days after discharge of the patient
measure: Number of examined lymph nodes
timeFrame: At surgery
measure: Type of resection (R0 or R1)
timeFrame: At surgery
measure: Pathological evaluation of mesocolic resection quality
timeFrame: At surgery
measure: Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30)
timeFrame: At randomization and three months postoperatively
measure: Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)
timeFrame: At randomization and three months postoperatively
measure: Mini Mental State (MMS) Examination or Folstein test
timeFrame: Before randomization and three months postoperatively
measure: Katz Activities of Daily Living (ADL) scale
timeFrame: Before randomization and three months postoperatively
measure: Geriatric Depression Scale (GDS)
timeFrame: Before randomization and three months postoperatively
measure: Timed Get-up-and-go (TGUG)
timeFrame: Before randomization and three months postoperatively
Other outcomes:
measure: To establish a specific molecular classification of colon cancer in the elderly from expression chips
timeFrame: within the 15 years after the tumor sampling
measure: To establish associations between molecular subtypes, the clinical and histological factors and relevant genetic alterations
timeFrame: within the 15 years after the tumor sampling
measure: To establish a possible link between these molecular subtypes and overall survival of patients
timeFrame: within the 15 years after the tumor sampling
measure: To compare our molecular classification with the different classifications already published in the literature on colorectal cance
timeFrame: within the 15 years after the tumor sampling
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Gilles MANCEAU, M.D., PhD.,
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manceau G, Brouquet A, Chaibi P, Passot G, Bouche O, Mathonnet M, Regimbeau JM, Lo Dico R, Lefevre JH, Peschaud F, Facy O, Volpin E, Chouillard E, Beyert-Berjot L, Verny M, Karoui M, Benoist S. Multicenter phase III randomized trial comparing laparoscopy and laparotomy for colon cancer surgery in patients older than 75 years: the CELL study, a Federation de Recherche en Chirurgie (FRENCH) trial. BMC Cancer. 2019 Dec 4;19(1):1185. doi: 10.1186/s12885-019-6376-8.