Colonic CancerCELLNCT03033719
Colectomy for Cancer in the Elderly by Laparoscopy or Laparotomy
A study testing Laparotomy and Laparoscopy in people with Colonic Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Colonic Cancer
- What is being tested?
- Laparotomy and Laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jul 2017to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 75 years
- Histologically proven colonic adenocarcinoma (> 15 cm from the anal margin) or precancerous colonic lesion non endoscopically resectable
- 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)
- No previous colonic cancer within the 5 last years
- No peritoneal carcinosis on CT-scan
- Patient able to fill in an auto-questionnaire alone or with some help
- MMS (Mini Mental Score) ≥ 15
- Given oral consent (formal informed consent is not required by French law for accepted procedures)
Who cannot join
- Rectal cancer (≤ 15 cm from the anal margin)
- Locally advanced (cT4) or complicated tumor requiring extended resection or emergency surgery
- Synchronous colonic cancer
- - Scheduled need for synchronous intra-abdominal surgery, including surgery for liver metastases
- Absolute contraindications to general anesthesia or prolonged pneumoperitoneum
- Patient not able to tolerate colon surgery according to the global comprehensive geriatric assessment
Show all 11Show fewer
- Estimated life expectancy less than 6 months
- Patient under guardianship
- Other known active cancer (except nonmelanomatous skin cancer)
- Patient not affiliated to the social security system
- Previous colonic resection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier Pitié Salpêtrière
Paris, 75013
Gilles MANCEAU, MD, gilles.manceau@aphp.fr
About this study
Official title: Multicenter Randomized Trial Comparing Laparoscopy and Laparotomy for Colon Cancer Surgery in Patients Older Than 75 Years
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
Read the 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).
- Conditions
- Colonic Cancer
- Being tested
- Laparotomy, Laparoscopy
- Keywords
- Colorectal Surgery, Geriatrics, Digestive Oncology, Colon cancer, Elderly patients, Laparoscopy, Laparotomy, Morbidity
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparotomyProcedure or surgery
Also called Open surgery
Open surgery
LaparoscopyProcedure or surgery
Also called Minimally invasive surgery
Minimally invasive surgery
| Study group | Role | What they receive |
|---|---|---|
| Laparotomy | Active comparator | Open surgery Receives: Procedure: Laparotomy |
| Laparoscopy | Experimental | Minimally invasive surgery Receives: Procedure: Laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 30 days after the surgery
Secondary outcomes (11)
Postoperative mortality
Death from any cause
Measured: Evaluated at 30 days and at 90 days after the surgery
Rate of readmission
Defined as any rehospitalization whatever the cause
Measured: Within the 30 days after discharge of the patient
Number of examined lymph nodes
Quality of surgical resection : Number of examined lymph nodes
Measured: At surgery
Type of resection (R0 or R1)
Quality of surgical resection : Type of resection (R0 or R1)
Measured: At surgery
Pathological evaluation of mesocolic resection quality
Quality of surgical resection : Pathological evaluation of mesocolic resection quality
Measured: At surgery
Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30)
Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30)
Measured: At randomization and three months postoperatively
Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)
Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)
Measured: At randomization and three months postoperatively
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)
Measured: Before randomization and three months postoperatively
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)
Measured: Before randomization and three months postoperatively
Geriatric Depression Scale (GDS)
Evolution of geriatric scores :The Geriatric Depression Scale (GDS) (Comprehensive geriatric assessment performed by a geriatrician on each site)
Measured: Before randomization and three months postoperatively
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)
Measured: Before randomization and three months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start4 Jul 2017
- Primary completionApr 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles MANCEAU, M.D., PhD.,, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033719
- Sponsor's protocol ID
- K130901
- Other IDs
- 2016-A00312-49
- Acronym
- CELL
- Status last verified
- Jan 2018
- First submitted
- 10 Jan 2017
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31801485
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Trial Comparing Laparoscopy and Laparotomy for Colon Cancer Surgery in Patients Older Than 75 Years
- ClinicalTrials.gov ID
- NCT03033719
- Acronym / sponsor ID
- CELL / K130901
- Conditions
- Colonic Cancer
- Keywords
- Colorectal Surgery, Geriatrics, Digestive Oncology, Colon cancer, Elderly patients, Laparoscopy, Laparotomy, Morbidity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparotomy | Active comparator | Procedure: LaparotomyOpen surgery |
| Laparoscopy | Experimental | Procedure: LaparoscopyMinimally invasive surgery |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Age ≥ 75 years
- Histologically proven colonic adenocarcinoma (> 15 cm from the anal margin) or precancerous colonic lesion non endoscopically resectable
- 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)
- No previous colonic cancer within the 5 last years
- No peritoneal carcinosis on CT-scan
Key exclusion criteria (11 listed)
- Rectal cancer (≤ 15 cm from the anal margin)
- Locally advanced (cT4) or complicated tumor requiring extended resection or emergency surgery
- Synchronous colonic cancer
- - Scheduled need for synchronous intra-abdominal surgery, including surgery for liver metastases
- Absolute contraindications to general anesthesia or prolonged pneumoperitoneum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaparotomyAlso: Open surgeryOpen surgery | Procedure or surgery | Laparotomy |
| LaparoscopyAlso: Minimally invasive surgeryMinimally invasive surgery | Procedure or surgery | Laparoscopy |
Primary outcome
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
11 secondary outcomes
Postoperative mortality
Time frame: Evaluated at 30 days and at 90 days after the surgery
Rate of readmission
Time frame: Within the 30 days after discharge of the patient
Number of examined lymph nodes
Time frame: At surgery
Type of resection (R0 or R1)
Time frame: At surgery
Pathological evaluation of mesocolic resection quality
Time frame: At surgery
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-CR29)
Time frame: At randomization and three months postoperatively
Mini Mental State (MMS) Examination or Folstein test
Time frame: Before randomization and three months postoperatively
Katz Activities of Daily Living (ADL) scale
Time frame: Before randomization and three months postoperatively
Geriatric Depression Scale (GDS)
Time frame: Before randomization and three months postoperatively
Timed Get-up-and-go (TGUG)
Time frame: Before randomization and three months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Derived from this study: PubMed 31801485Manceau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles MANCEAU, M.D., PhD., principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparotomy and Laparoscopy in people with Colonic Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gilles MANCEAU, M.D., PhD., (00331 42 17 56 51, gilles.manceau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global postoperative morbidity in both arms (time frame: At 30 days after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03033719, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.