Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is IndicatedPhase 2PRIMMNCT01715363
Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer
A Phase 2 study testing Oxaliplatin, Folinic Acid and Fluorouracile in people with Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is Indicated, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
The purpose of this study is to analyze the clinical tolerance of immediate preoperative chemotherapy in terms of toxicity and perioperative morbidity and mortality Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is Indicated
- What is being tested?
- Oxaliplatin, Folinic Acid and Fluorouracile
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Jun 2014
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- colorectal metastatic adenocarcinoma (stage IV) with unresectables, measurables and visibles secondary lesions
- primitive tumor must be operate
- patient age between 18 and 70
- OMS status performance < 2
- life expectancy > 12 weeks
- hematologic function : PNN >/= 1.5x10^9/L, platelets >/= 100x10^9/L
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- hepatic function : bilirubin </= 1.5xLSN, AST and ALT </= 3xLSN, alcalin phosphatasis </= 3xLSN
- plasmatimic creatin </= 1.25xLSN
- No previous chemotherapy or pelvic radiotherapy
- men and women in age of procreate agreeing to use a contraception until 4 months after the end of treatment for women and until 6 months for men
Who cannot join
- nonmetastatic forms
- Colorectal tumor which requires preoperative radiotherapy
- nonmeasurable metastasis based on RECIST criteria
- previous chemotherapy for colorectal cancer
- previous irradiation of the primitive tumour
- specific indication against the treatment studied
- Patient considered as inoperable for physiological or carcinologic reasons
- Pregnant or breast feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of an Immediate Preoperative Chemotherapy Before Resection of Colorectal Cancer and Research of Gene Expressions Changes Induced in the Tumor, Predictive of Chemotherapy Efficiency
The purpose of this study is to analyze the clinical tolerance of immediate preoperative chemotherapy in terms of toxicity and perioperative morbidity and mortality
- Being tested
- Oxaliplatin, Folinic Acid, Fluorouracile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Folinic AcidDrug
FluorouracileDrug
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX + surgery + FOLFOX | Experimental | * Systemic chemotherapy (modified FOLFOX 4) 48 hours before surgery
* resection of the colorectal tumor during surgery
* Resumption of FOLFOX within the month after surgery (post operative administration of 4 course of treatment and assessment of the response) Receives: Drug: Oxaliplatin; Drug: Folinic Acid; Drug: Fluorouracile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical tolerance of immediate preoperative chemotherapy
Clinical tolerance of immediate preoperative chemotherapy assessment is based on the post-operative complication rate in terms of morbidity and mortality.
All the post-operative complications arising within 30 days after surgery will be registered and classified using the Clavien Dindo classification
Measured: Assess up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is IndicatedStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diane GOERE, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715363
- Sponsor's protocol ID
- 2011-003446-41
- Other IDs
- 2010/1676
- Acronym
- PRIMM
- Status last verified
- Feb 2016
- First submitted
- 24 Oct 2012
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Immediate Preoperative Chemotherapy Before Resection of Colorectal Cancer and Research of Gene Expressions Changes Induced in the Tumor, Predictive of Chemotherapy Efficiency
- ClinicalTrials.gov ID
- NCT01715363
- Acronym / sponsor ID
- PRIMM / 2011-003446-41
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Oct 2012 (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 analyze the clinical tolerance of immediate preoperative chemotherapy in terms of toxicity and perioperative morbidity and mortality
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFOX + surgery + FOLFOX | Experimental | Drug: Oxaliplatin, Drug: Folinic Acid, Drug: Fluorouracile* Systemic chemotherapy (modified FOLFOX 4) 48 hours before surgery * resection of the colorectal tumor during surgery * Resumption of FOLFOX within the month after surgery (post operative administration of 4 course of treatment and assessment of the response) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- colorectal metastatic adenocarcinoma (stage IV) with unresectables, measurables and visibles secondary lesions
- primitive tumor must be operate
- patient age between 18 and 70
- OMS status performance < 2
- life expectancy > 12 weeks
Key exclusion criteria (8 listed)
- nonmetastatic forms
- Colorectal tumor which requires preoperative radiotherapy
- nonmeasurable metastasis based on RECIST criteria
- previous chemotherapy for colorectal cancer
- previous irradiation of the primitive tumour
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 |
|---|---|---|
| Oxaliplatin | Drug | FOLFOX + surgery + FOLFOX |
| Folinic Acid | Drug | FOLFOX + surgery + FOLFOX |
| Fluorouracile | Drug | FOLFOX + surgery + FOLFOX |
Primary outcome
Clinical tolerance of immediate preoperative chemotherapy
Time frame: Assess up to 30 days after surgery
Clinical tolerance of immediate preoperative chemotherapy assessment is based on the post-operative complication rate in terms of morbidity and mortality. All the post-operative complications arising within 30 days after surgery will be registered and classified using the Clavien Dindo classification
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
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.
Diane GOERE, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin, Folinic Acid and Fluorouracile in people with Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is Indicated, run by Gustave Roussy, Cancer Campus, Grand 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 10 inclusion and 8 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 10 Feb 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties). 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?
Clinical tolerance of immediate preoperative chemotherapy (time frame: Assess up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2016.