Gastric CancerPhase 2CEPAFIRINCT00210184
Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years of Age and Older With Gastric Cancer
A Phase 2 study testing Irinotecan associated to fluorouracil and leucovorin in people with Gastric Cancer, run by Institut Bergonié at 6 sites in France.
Trial summary
The number of patients over 70 years old with cancer is increasing in France. This population is heterogenous: physiological functions, presence of co-morbidities, and autonomy can vary a lot between subjects of the same age. Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Irinotecan associated to fluorouracil and leucovorin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 6 sitesFrance
- Study dates
- 21 Jul 2004to Apr 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 70 years of age or older
- Gastric cancer, locally advanced or metastatic
- No previous adjuvant treatment (surgery, radiotherapy, chemotherapy) in the last 6 months
- One measurable lesion
- ECOG < 3
- Biology and biochemistry within normal limits
- Life expectancy > 12 weeks
Who cannot join
- Other palliative chemotherapy for this cancer
- Other cancer in the last 5 years
- Previous treatment with irinotecan
- Atropine treatment not possible
- Concomitant cancer therapy except bone radiotherapy
- Metastases to brain or meninges with symptoms
- Other severe pathology uncontrolled
- Problem of compliance
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33076
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, 33076
Hopital Robert Boulin
Libourne, 33700
Centre Hospitalier Universitaire de Pau
Pau, 64000
Clinique Francheville
Périgueux, 24000
Centre Hospitalier Universitaire de Villeneuve sur Lot
Villeneuve-sur-Lot, 47000
About this study
Official title: Multicentric Phase II Trial: Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years Old and More Presenting Gastric Cancer Locally Advanced or Metastatic
The number of patients over 70 years old with cancer is increasing in France. This population is heterogenous: physiological functions, presence of co-morbidities, and autonomy can vary a lot between subjects of the same age. Physicians hesitate to treat them with optimal doses because they are afraid of the risk of toxicity in spite of the benefits of treatment. Fifty eight percent of gastric cancers are diagnosed in patients over the age of 70 in France. FOLFIRI (irinotecan, leucovorin and fluorouracil) chemotherapy appears to be a promising treatment for digestive cancer. It increases the level of response and survival without major toxicity. It becomes necessary to evaluate patients, to propose adapted treatments for their conditions.
The principal objectives are to demonstrate the efficacy of treatment, safety, survival and to find out if geriatric assessment data can help to better predict chemotherapy toxicity. The researchers plan to accrue 43 patients diagnosed with locally advanced or metastatic gastric cancer. They will receive FOLFIRI and 4 geriatric evaluations: before treatment, day 1 cycle 2, day 1 cycle 4 and at the end of chemotherapy. These evaluations include tests of cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up and Go), activities (ADL; IADL), quality of life (QLQ-C30), depression (GDS-15) and Lachs-Balducci screening.
- Conditions
- Gastric Cancer
- Being tested
- Irinotecan associated to fluorouracil and leucovorin
- Keywords
- Chemotherapy, gastric cancer, geriatric evaluation, efficacy, safety
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan associated to fluorouracil and leucovorinDrug
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan associated to fluorouracil and leucovorin | Experimental | On D1, as a single 90-minute intravenous infusion diluted in 250 ml of saline (sodium chloride a 9 ‰), or isotonic glucose, at a dose of 180 mg/m2. Dosage adjustments are provided in case of severe toxicity.
Then 5FU/ folinic acid: 400 mg/m2 of 5-FU as an IV bolus followed by a continuous 2400 mg/m2 infusion over 46 hours with 400 mg/m2 of folinic acid or 200 mg/m2 of l-folinic acid as a 2-hour infusion before 5-FU administration.
Doses of 5-FU are adjusted according to clinical tolerance. Resume on D15 for 6 months Receives: Drug: Irinotecan associated to fluorouracil and leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-month Response Rate
Response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.
Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).
Measured: 2 months
Secondary outcomes (2)
Overall Survival
OS was defined as the time from trial inclusion to death due to any cause. Participants without documented death were censored at the date of the last follow-up or last patient contact. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Measured: From date of inclusion until the date of date of death from any cause, assessed up to 12 months.
Progression-free Survival
PFS was defined as time since trial inclusion to progression or death from any cause, whichever occurred first, and data from patients progression-free and lost to follow-up before the study end were censored at date of last news. The PFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study start21 Jul 2004
- Primary completionApr 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, Sanofi-Synthelabo, Aventis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Marianne FONCK, MD, Principal investigator, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210184
- Sponsor's protocol ID
- IB2004-18
- Other IDs
- CEPAFIRI
- Acronym
- CEPAFIRI
- Status last verified
- Sep 2021
- First submitted
- 13 Sep 2005
- Last updated
- 6 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Fonck M, Brunet R, Becouarn Y, Legoux JL, Dauba J, Cany L, Smith D, Auby D, Terrebonne E, Traissac L, Mertens C, Soubeyran P, Bellera C, Rainfray M, Mathoulin-Pelissier S. Evaluation of efficacy and safety of FOLFIRI for elderly patients with gastric cancer: a first-line phase II study. Clin Res Hepatol Gastroenterol. 2011 Dec;35(12):823-30. doi: 10.1016/j.clinre.2011.08.002. Epub 2011 Sep 8.
PubMed 21907007
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Phase II Trial: Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years Old and More Presenting Gastric Cancer Locally Advanced or Metastatic
- ClinicalTrials.gov ID
- NCT00210184
- Acronym / sponsor ID
- CEPAFIRI / IB2004-18
- Conditions
- Gastric Cancer
- Keywords
- Chemotherapy, gastric cancer, geriatric evaluation, efficacy, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Novartis, Sanofi-Synthelabo, Aventis Pharmaceuticals
- Study start
- 21 Jul 2004 (actual)
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 16 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The number of patients over 70 years old with cancer is increasing in France. This population is heterogenous: physiological functions, presence of co-morbidities, and autonomy can vary a lot between subjects of the same age. Physicians hesitate to treat them with optimal doses because they are afraid of the risk of toxicity in spite of the benefits of treatment. Fifty eight percent of gastric cancers are diagnosed in patients over the age of 70 in France. FOLFIRI (irinotecan, leucovorin and fluorouracil) chemotherapy appears to be a promising treatment for digestive cancer. It increases the level of response and survival without major toxicity. It becomes necessary to evaluate patients, to propose adapted treatments for their conditions.
The principal objectives are to demonstrate the efficacy of treatment, safety, survival and to find out if geriatric assessment data can help to better predict chemotherapy toxicity. The researchers plan to accrue 43 patients diagnosed with locally advanced or metastatic gastric cancer. They will receive FOLFIRI and 4 geriatric evaluations: before treatment, day 1 cycle 2, day 1 cycle 4 and at the end of chemotherapy. These evaluations include tests of cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up and Go), activities (ADL; IADL), quality of life (QLQ-C30), depression (GDS-15) and Lachs-Balducci screening.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irinotecan associated to fluorouracil and leucovorin | Experimental | Drug: Irinotecan associated to fluorouracil and leucovorinOn D1, as a single 90-minute intravenous infusion diluted in 250 ml of saline (sodium chloride a 9 ‰), or isotonic glucose, at a dose of 180 mg/m2. Dosage adjustments are provided in case of severe toxicity. Then 5FU/ folinic acid: 400 mg/m2 of 5-FU as an IV bolus followed by a continuous 2400 mg/m2 infusion over 46 hours with 400 mg/m2 of folinic acid or 200 mg/m2 of l-folinic acid as a 2-hour infusion before 5-FU administration. Doses of 5-FU are adjusted according to clinical tolerance. Resume on D15 for 6 months |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 70 years of age or older
- Gastric cancer, locally advanced or metastatic
- No previous adjuvant treatment (surgery, radiotherapy, chemotherapy) in the last 6 months
- One measurable lesion
- ECOG < 3
Key exclusion criteria (8 listed)
- Other palliative chemotherapy for this cancer
- Other cancer in the last 5 years
- Previous treatment with irinotecan
- Atropine treatment not possible
- Concomitant cancer therapy except bone radiotherapy
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 |
|---|---|---|
| Irinotecan associated to fluorouracil and leucovorin | Drug | Irinotecan associated to fluorouracil and leucovorin |
Primary outcome
2-month Response Rate
Time frame: 2 months
Response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0. Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).
2 secondary outcomes
Overall Survival
Time frame: From date of inclusion until the date of date of death from any cause, assessed up to 12 months.
Progression-free Survival
Time frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21907007Fonck M, Brunet R, Becouarn Y, Legoux JL, Dauba J, Cany L, Smith D, Auby D, Terrebonne E, Traissac L, Mertens C, Soubeyran P, Bellera C, Rainfray M, Mathoulin-Pelissier S. Evaluation of efficacy and safety of FOLFIRI for elderly patients with gastric cancer: a first-line phase II study. Clin Res Hepatol Gastroenterol. 2011 Dec;35(12):823-30. doi: 10.1016/j.clinre.2011.08.002. Epub 2011 Sep 8.
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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.
Marianne FONCK, MD principal investigator
Institut Bergonié
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan associated to fluorouracil and leucovorin in people with Gastric Cancer, run by Institut Bergonié at 6 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 7 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: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
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?
Yes. Results are posted in the registry (first posted 16 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
2-month Response Rate (time frame: 2 months). 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 NCT00210184, 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 6 Oct 2021.