Colorectal CancerMETASYNCNCT00264979
Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases
A study testing Simultaneous surgery and Sequential surgery in people with Colorectal Cancer and Hepatic Metastases, run by Rennes University Hospital at 14 sites in France.
Trial summary
The surgical strategy for the treatment of synchronous colorectal cancer liver metastases has not still been defined. The purpose of this study is to compare two treatment strategies in which liver resection is performed either during, or 12 to 14 weeks after the primary resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Hepatic Metastases
- What is being tested?
- Simultaneous surgery and Sequential surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 14 sitesFrance
- Study dates
- 2 Mar 2006to 11 Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults over 18 years old
- At least one adenocarcinoma of colon and/or rectum, histologically proven.
- No local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion)
- At least one hepatic metastasis which R0 resection is possible through a conventional simple resection
- Informed written consent.
- Non inclusion criteria:
Show all 10Show fewer
- Heart, Respiratory or Renal failure
- Physical or psychological dependence
- Chronic liver disease
- Extra-hepatic metastases
Who cannot join
- Localized or diffuse peritoneal carcinomatosis
- Non resectable lymph node metastases
- Colorectal or hepatic tumour extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately
- Other hepatic lesions diagnosed with ultrasound making liver R0 resection impossible immediately
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Chirurgie générale viscérale et digestive - Hôpital Nord
Amiens, 80080
Service de Chirurgie viscérale, digestive et cancérologie - Hôpital Jean Mingoz
Besançon, 25000
Chirurgie digestive, thoracique et cancérologie
Dijon, 21000
Département de Chirurgie - CRLCC Léon Bérard
Lyon, 69008
Clinique Chirurgicale A - Hôtel Dieu
Nantes, 44093
Clinique Chirurgicale I - Hôpital Nord
Nantes, 44093
Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine
Paris, 75570
Service de Chirurgie hépato-biliaire et Transplantation Hépatique- Paris Saint Antoine
Paris
Service de Chirurgie - Hôpital Jean Bernard
Poitiers, 86021
Service d'Oncologie Digestive- CRLCC Eugène Marquis
Rennes, 35000
Département de Chirurgie Viscérale - Hôpital Pontchaillou
Rennes, 35033
Centre de Chirurgie Viscérale et de Transplantation - CHU de Hautepierre
Strasbourg, 67098
Chirurgie Viscérale Digestive - CH Chubert
Vannes, 70555
Centre Hépato-biliaire - Hôpital Paul Brousse
Villejuif
About this study
Official title: Prospective Randomized Study Comparing the Morbidity and Mortality After Liver Resection for Synchronous Colorectal Cancer Metastases When Performed Either During or 12 to 14 Weeks After the Primary Resection
The surgical strategy for the treatment of synchronous colorectal cancer liver metastases has not still been defined. The purpose of this study is to compare two treatment strategies in which liver resection is performed either during, or 12 to 14 weeks after the primary resection. Endpoints include the rate of severe complications and survival.
Read the detailed description
In France, 35 000 colorectal cancers are diagnosed each year, 15 to 25% of which with hepatic metastases. It is nowadays admitted that the complete resection of these hepatic metastases represents the only treatment that has been shown to increase survival. The aim of this study is to evaluate the efficacy/safety ratio of the liver surgery when performed simultaneously or at distance of the primitive tumour ablation. Patients are randomized to undergo liver surgery either during, or 12 to 14 weeks after the primary resection. The primary endpoint is the rate of patients with at least one severe complication within 60 days after surgery. Secondary endpoints evaluate long-term clinical outcomes, in particular recurrence-free survival.
- Conditions
- Colorectal Cancer, Hepatic Metastases
- Being tested
- Simultaneous surgery, Sequential surgery
- Keywords
- Colorectal cancer, Sequential or simultaneous surgery, Synchronous hepatic metastases
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous surgeryProcedure or surgery
Simultaneous surgery of colorectal cancer and synchronous liver metastases
Sequential surgeryProcedure or surgery
Sequential surgeries of colorectal cancer and synchronous liver metastases: the metastases surgery will be programmed 12 to 14 weeks after the primary tumour exeresis.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Simultaneous surgery of colorectal cancer and synchronous liver metastases Receives: Procedure: Simultaneous surgery |
| 2 | Other | Sequential surgeries of colorectal cancer and synchronous liver metastases Receives: Procedure: Sequential surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with at least one postoperative severe complication within 60 days after each surgery
Measured: 60 days after each surgery
Secondary outcomes (6)
Death rate during hospitalization or within 60 days after each surgery
Measured: 60 days after each surgery
Rate and number of severe general, digestive or hepatic complications
Measured: 2 years after the first surgery
Rate of unachieved hepatic resection
Measured: Day of the hepatic surgery
Global survival distribution and 2 years global survival rate
Measured: 2 years after the first surgery
Recurrence-free survival distribution and 2 years recurrence-free survival rate
Measured: 2 years
Two years recurrence rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study start2 Mar 2006
- Primary completion11 Dec 2017
- Study completion11 Dec 2017
Why it stopped: Stop recommended following the last sequential analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Karim Boudjema, MD, PhD, Principal investigator, Rennes University HospitalJean-Luc Raoul, MD, Principal investigator, Centre Eugène Marquis - CRLCC RennesEric Bellissant, MD, PhD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264979
- Sponsor's protocol ID
- DGS 2005/0193
- Other IDs
- PHRC/04-01, CIC0203/030
- Acronym
- METASYNC
- Status last verified
- Mar 2019
- First submitted
- 12 Dec 2005
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martin R, Paty P, Fong Y, Grace A, Cohen A, DeMatteo R, Jarnagin W, Blumgart L. Simultaneous liver and colorectal resections are safe for synchronous colorectal liver metastasis. J Am Coll Surg. 2003 Aug;197(2):233-41; discussion 241-2. doi: 10.1016/S1072-7515(03)00390-9.
PubMed 12892803Weber JC, Bachellier P, Oussoultzoglou E, Jaeck D. Simultaneous resection of colorectal primary tumour and synchronous liver metastases. Br J Surg. 2003 Aug;90(8):956-62. doi: 10.1002/bjs.4132.
PubMed 12905548
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Comparing the Morbidity and Mortality After Liver Resection for Synchronous Colorectal Cancer Metastases When Performed Either During or 12 to 14 Weeks After the Primary Resection
- ClinicalTrials.gov ID
- NCT00264979
- Acronym / sponsor ID
- METASYNC / DGS 2005/0193
- Conditions
- Colorectal Cancer, Hepatic Metastases
- Keywords
- Colorectal cancer, Sequential or simultaneous surgery, Synchronous hepatic metastases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stop recommended following the last sequential analysis
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 2 Mar 2006 (actual)
- Primary completion
- 11 Dec 2017 (actual)
- Study completion
- 11 Dec 2017 (actual)
- First posted
- 13 Dec 2005 (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 surgical strategy for the treatment of synchronous colorectal cancer liver metastases has not still been defined. The purpose of this study is to compare two treatment strategies in which liver resection is performed either during, or 12 to 14 weeks after the primary resection. Endpoints include the rate of severe complications and survival.
Detailed description
In France, 35 000 colorectal cancers are diagnosed each year, 15 to 25% of which with hepatic metastases. It is nowadays admitted that the complete resection of these hepatic metastases represents the only treatment that has been shown to increase survival. The aim of this study is to evaluate the efficacy/safety ratio of the liver surgery when performed simultaneously or at distance of the primitive tumour ablation. Patients are randomized to undergo liver surgery either during, or 12 to 14 weeks after the primary resection. The primary endpoint is the rate of patients with at least one severe complication within 60 days after surgery. Secondary endpoints evaluate long-term clinical outcomes, in particular recurrence-free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Simultaneous surgerySimultaneous surgery of colorectal cancer and synchronous liver metastases |
| 2 | Other | Procedure: Sequential surgerySequential surgeries of colorectal cancer and synchronous liver metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female adults over 18 years old
- At least one adenocarcinoma of colon and/or rectum, histologically proven.
- No local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion)
- At least one hepatic metastasis which R0 resection is possible through a conventional simple resection
- Informed written consent.
Key exclusion criteria (4 listed)
- Localized or diffuse peritoneal carcinomatosis
- Non resectable lymph node metastases
- Colorectal or hepatic tumour extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately
- Other hepatic lesions diagnosed with ultrasound making liver R0 resection impossible immediately
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 |
|---|---|---|
| Simultaneous surgerySimultaneous surgery of colorectal cancer and synchronous liver metastases | Procedure or surgery | 1 |
| Sequential surgerySequential surgeries of colorectal cancer and synchronous liver metastases: the metastases surgery will be programmed 12 to 14 weeks after the primary tumour exeresis. | Procedure or surgery | 2 |
Primary outcome
Rate of patients with at least one postoperative severe complication within 60 days after each surgery
Time frame: 60 days after each surgery
6 secondary outcomes
Death rate during hospitalization or within 60 days after each surgery
Time frame: 60 days after each surgery
Rate and number of severe general, digestive or hepatic complications
Time frame: 2 years after the first surgery
Rate of unachieved hepatic resection
Time frame: Day of the hepatic surgery
Global survival distribution and 2 years global survival rate
Time frame: 2 years after the first surgery
Recurrence-free survival distribution and 2 years recurrence-free survival rate
Time frame: 2 years
Two years recurrence rate
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Stop recommended following the last sequential analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Background: PubMed 12892803Martin R, Paty P, Fong Y, Grace A, Cohen A, DeMatteo R, Jarnagin W, Blumgart L. Simultaneous liver and colorectal resections are safe for synchronous colorectal liver metastasis. J Am Coll Surg. 2003 Aug;197(2):233-41; discussion 241-2. doi: 10.1016/S1072-7515(03)00390-9.
- Background: PubMed 12905548Weber JC, Bachellier P, Oussoultzoglou E, Jaeck D. Simultaneous resection of colorectal primary tumour and synchronous liver metastases. Br J Surg. 2003 Aug;90(8):956-62. doi: 10.1002/bjs.4132.
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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.
Karim Boudjema, MD, PhD principal investigator
Rennes University Hospital
Jean-Luc Raoul, MD principal investigator
Centre Eugène Marquis - CRLCC Rennes
Eric Bellissant, MD, PhD study chair
Rennes University Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous surgery and Sequential surgery in people with Colorectal Cancer and Hepatic Metastases, run by Rennes University Hospital at 14 sites 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 10 inclusion and 4 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: stopped early, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
The study was stopped early (reason given: Stop recommended following the last sequential analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with at least one postoperative severe complication within 60 days after each surgery (time frame: 60 days after each 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 NCT00264979, which also lists 2 linked publications.
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 11 Mar 2019.