Trial · NCT02352337
First-line Metastatic Pancreatic Cancer : FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem
NCT02352337, Phase 2, Completed, Federation Francophone de Cancerologie Digestive; results first posted 2024-07-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. First-line Metastatic Pancreatic Cancer : FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem. Trials, record NCT02352337. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02352337
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- First-line Metastatic Pancreatic Cancer : FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem
- NCT number
- NCT02352337
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 276 participants, actual
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Conditions
- Metastatic Pancreatic Cancer
- Interventions
- FOLFIRINOX, LV5FU2, FOLFIRI.3, Gemcitabine
- First posted
- 2015-02-02
- Last updated
- 2024-07-10
- Results first posted
- 2024-07-10
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization. | 6 months after randomization | Progression was defined as radiological progression according to RECIST v1.1 criteria and/or clinical progression according to the investigator. Progression or death (for any reason) was considered if the event occured within the first 6 months since randomization. 6 month scans were 6 month scans with a +/- 1 month window. |
| Secondary | Overall Survival (OS) | Up to 3 years after the treatment start | Overall survival was defined as the time from the date of randomization to the patient's death (all causes). For alive patients, the date of last news was taken into account. The analysis was done on the ITT population meaning the patients who have been randomized. Numbers of patients correspond the number of patients randomized in the study. |
| Secondary | Progression-free Survival (PFS) | up to 12 months after randomization | It was defined as the time between t randomization and the date of the first radiological progression (RECIST 1.1 criteria) and/or clinical progression according to the investigator or death (whatever the cause is); Patients alive without progression were censored at date of last news . |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization. | 6 months after randomization | The primary endpoint was analysed on the mITT population meaning all the randomized patients with at least one dose of study drug taken | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | Up to 3 years after the treatment start | Endpoint was analyzed on the ITT population meaning the patients randomized in the study. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | up to 12 months after randomization | The analysis was done on the ITT population meaning the patients who have been randomized into the study | months | MEDIAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization. | FOLFIRINOX | 41 | Participants | ||
| Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization. | FOLFIRINOX + LV5FU2 in Maintenance | 39 | Participants | ||
| Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization. | FIRGEM | 30 | Participants | ||
| Overall Survival (OS) | FOLFIRINOX | 10.09 | 95% Confidence Interval 8.54 to 12.16 | months | |
| Overall Survival (OS) | FOLFIRINOX + LV5FU2 in Maintenance | 11.20 | 95% Confidence Interval 9.03 to 13.14 | months | |
| Overall Survival (OS) | FIRGEM | 7.34 | 95% Confidence Interval 5.72 to 9.49 | months | |
| Progression-free Survival (PFS) | FOLFIRINOX | 6.28 | 95% Confidence Interval 5.32 to 7.56 | months | |
| Progression-free Survival (PFS) | FOLFIRINOX + LV5FU2 in Maintenance | 5.73 | 95% Confidence Interval 5.26 to 7.29 | months | |
| Progression-free Survival (PFS) | FIRGEM | 4.50 | 95% Confidence Interval 3.48 to 5.72 | months |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FOLFIRINOX | 91 | |
| Overall Study | STARTED | FOLFIRINOX + LV5FU2 in Maintenance | 92 | |
| Overall Study | STARTED | FIRGEM | 90 | |
| Overall Study | COMPLETED | FOLFIRINOX | 87 | |
| Overall Study | COMPLETED | FOLFIRINOX + LV5FU2 in Maintenance | 91 | |
| Overall Study | COMPLETED | FIRGEM | 88 | |
| Overall Study | NOT COMPLETED | FOLFIRINOX | 4 | |
| Overall Study | NOT COMPLETED | FOLFIRINOX + LV5FU2 in Maintenance | 1 | |
| Overall Study | NOT COMPLETED | FIRGEM | 2 |
Source ClinicalTrials.gov
Adverse events78
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alopecia | Skin and subcutaneous tissue disorders | FOLFIRINOX | 20 | 88 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | FOLFIRINOX + LV5FU2 in Maintenance | 21 | 91 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | FIRGEM | 20 | 87 | |
| other | Palmo-plantar syndrome | Skin and subcutaneous tissue disorders | FOLFIRINOX | 5 | 88 | |
| other | Palmo-plantar syndrome | Skin and subcutaneous tissue disorders | FOLFIRINOX + LV5FU2 in Maintenance | 18 | 91 | |
| other | Palmo-plantar syndrome | Skin and subcutaneous tissue disorders | FIRGEM | 3 | 87 | |
| other | Dysgueusia | Nervous system disorders | FOLFIRINOX | 3 | 88 | |
| other | Dysgueusia | Nervous system disorders | FOLFIRINOX + LV5FU2 in Maintenance | 9 | 91 | |
| other | Dysgueusia | Nervous system disorders | FIRGEM | 3 | 87 | |
| other | Neurotoxicity | Nervous system disorders | FOLFIRINOX | 68 | 88 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FOLFIRINOX | 82 | 91 |
| Total, all-cause mortality | FOLFIRINOX + LV5FU2 in Maintenance | 80 | 92 |
| Total, all-cause mortality | FIRGEM | 83 | 90 |
| Total, other adverse events | FOLFIRINOX | 88 | 88 |
| Total, other adverse events | FOLFIRINOX + LV5FU2 in Maintenance | 91 | 91 |
| Total, other adverse events | FIRGEM | 87 | 87 |
| Total, serious adverse events | FOLFIRINOX | 31 | 88 |
| Total, serious adverse events | FOLFIRINOX + LV5FU2 in Maintenance | 53 | 91 |
| Total, serious adverse events | FIRGEM | 57 | 87 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02352337
GET https://conductscience.org/api/trials/v1/NCT02352337/events?page=2