Pancreatic AdenocarcinomaPhase 3GEMFOXNCT04167007
FOLFOX vs Gemcitabine in Patients With Metastatic Pancreatic Cancer Non-fit to FOLFIRINOX
A Phase 3 study testing Gemcitabine and FOLFOX in people with Pancreatic Adenocarcinoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Pancreatic adenocarcinoma (PAC) incidence increases regularly in Western countries and it is expected to become the second leading cause of cancer-related mortality in 2020. The prognosis of this disease remains very poor with an overall 5-year survival rate less than 5%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Gemcitabine and FOLFOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2020to Jul 2025
- Phase
- Phase 3
- 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
- Signed and dated informed consent, and willing and able to comply with protocol requirements,
- Histologically or cytologically proven adenocarcinoma of the pancreas,
- In absence of histologically or cytologically proven adenocarcinoma, a cluster of clinical, biological and radiological arguments consistent with the diagnosis: among these, a hypodense pancreatic tumor at CT and a Ca 19-9 greater than 500 UI/ml are essential prerequisites,
- Metastatic disease confirmed (stage IV),
- No prior therapy for metastatic disease (in case of previous adjuvant therapy, interval from end of chemotherapy and relapse must be >12 months),
- Age ≥18 years ,
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- Patient non-fit for FOLFIRINOX,
- For patients with ECOG performance status (PS ) ≥2, an albuminemia level >25 g/l is required,
- Haematological status: neutrophils (ANC) >2x109/L; platelets >100x109/L; haemoglobin ≥9g/dL,
- Adequate renal function: serum creatinine level <150μM, and estimated creatinine clearance >30ml/min,
- Adequate liver function: AST (SGOT) and ALT (SGPT) ≤2.5xULN (≤5xULN in case of liver metastases),
- Total bilirubin ≤3 x ULN,
- QT / QTc interval at baseline ECG (performed within 1 month before randomization) < than 450 msec for men and < than 470 msec for women,
- Baseline evaluations performed before randomization: clinical and blood evaluations no more than 2 weeks (14 days) prior to randomization, tumor assessment (CT-scan or MRI, evaluation of non-measurable lesions) no more than 3 weeks (21 days) prior to randomization,
- Female patients must be surgically sterile, or be postmenopausal, or must commit to using reliable and appropriate methods of contraception during the study and during at least six months after the end of study treatment (when applicable). All female patients with reproductive potential must have a negative pregnancy test (β HCG) within 7 days prior to starting protocol treatment. Breastfeeding is not allowed.
- Male patients must agree to use effective contraception in addition to having their partner use a contraceptive method as well during the trial and during at least six months after the end of the study treatment
- Affiliation to a French social security system (recipient or assign).
Who cannot join
- History or evidence upon physical examination of CNS metastasis unless adequately treated (e.g. non irradiated CNS metastasis, seizure not controlled with standard medical therapy),
- Local or locally advanced disease (stage I to III),
- Patient uses warfarin,
- Patient receiving concomitant radiotherapy,
- Electrolytic report uncontrolled: hypercalcemia and/or hypokalemia and/or hypomagnesemia,
- Pre-existing permanent neuropathy (NCI grade ≥2 ),
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- Poor nutritional status
- Known dihydropyrimidine dehydrogenase (DPD) total or partial deficiency (DPD activity dosage at inclusion visit),
- Concomitant unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy),
- Treatment with any other investigational medicinal product within 28 days prior to study entry,
- Other serious and uncontrolled non-malignant disease (eg. active infection requiring systemic therapy, coronary stenting or myocardial infarction or stroke in the past 6 months),
- Known or historical active infection with HIV, or known active infection untreated with hepatitis B or hepatitis C ,
- Known uncontrolled bacterial infection
- History or active interstitial lung disease (ILD),
- Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years,
- Patients with known allergy to active substance or any excipient of study drugs,
- Allergy to iodinated contrast product
- Concomitant administration of live, attenuated virus vaccine and concomitant administration of prophylactic phenytoin.
- Patients under legal protection or unable to consent
- Participation in another interventional research
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
APHP - Groupe Hospitalier Pitié-Salpêtrière
Paris, 75013
Jean-Baptiste BACHET, MD, PhD, jean-basptiste.bachet@aphp.fr
0142161041 / 0142161045
About this study
Official title: Randomized Phase 3 Trial Comparing FOLFOX to Gemcitabine in Metastatic First-line in Patients With Pancreatic Adenocarcinoma and Non-fit for FOLFIRINOX
Pancreatic adenocarcinoma (PAC) incidence increases regularly in Western countries and it is expected to become the second leading cause of cancer-related mortality in 2020. The prognosis of this disease remains very poor with an overall 5-year survival rate less than 5%.
The FOLFIRINOX regimen (5-fluorouracil [5-FU], folinic acid, irinotecan, and oxaliplatin) and the combination of nab-paclitaxel with gemcitabine demonstrated to be more effective than gemcitabine alone, and are both validated as standard first-line treatment options for metastatic PAC. However, the use of FOLFIRINOX is limited to patients with ECOG performance status (PS) 0-1 and aged less than 75 years. Nab-paclitaxel is currently not reimbursed in France.
Read the detailed description
This trial is an open label, multicenter, randomized phase III trial comparing gemcitabine vs FOLFOX in patients with metastatic pancreatic adenocarcinoma and non-fit for FOLFIRINOX. Adults fulfilling inclusion criteria and non-inclusion criteria will be randomized between a FOLFOX arm and a gemcitabine arm. The primary endpoint is the overall survival (OS) at 24 months. The secondary objectives are : objective response rate and disease control rate (RECIST v1.1, in case of evaluable lesion), duration of response, duration of disease control, progression free survival (PFS), the evolution of biomarkers Ca 19-9 and CEA under treatment, the toxicities according to International Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, the safety of both arms, the quality of life, the dose intensity (DI) of each protocol, the Quality-Adjusted Survival, and the rate and type of second-line / third-line regimens chemotherapy. With an expected median survival time in the control group of 5 months, an accrual period of 3 years and a minimum follow-up period of 2 years, a total of 199 patients per group are required to detect a hazard ratio of 0.75 based on a 5% two-sided type I error rate and a power of 80%, leading to a total number of 400 patients to include.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- Gemcitabine, FOLFOX
- Keywords
- Pancreatic adenocarcinoma, Metastasis, Gemcitabine, FOLFOX, first-line
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Gemcitabine at 1000 mg/m² as intravenous (IV) infusion over 30-40 minutes on days 1, 8, and 15, followed by 1 week of rest, every 28 days
FOLFOXDrug
Oxaliplatin at 85 mg/m² given as a 2 hours IV infusion on days 1 and 15; Folinic acid 400 mg/m² (racemic form) or 200 mg/m² (L-form) in 250 ml glucose 5% solution given as a 2 hours IV infusion on days 1 and 15; and 5-FU 2400 mg/m² administered as continuous 46-hour IV infusion on days 1-3 and 15-17, every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Gemcitabine at 1000 mg/m² Receives: Drug: Gemcitabine |
| Group II | Active comparator | Oxaliplatin at 85 mg/m² ; Folinic acid 400 mg/m² (racemic form) or 200 mg/m² (L-form) and 5-FU 2400 mg/m² Receives: Drug: FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS) at 24 months
OS will be defined as the delay between the date of inclusion and the date of death (whatever the cause) or the date of last news if the patient is alive.
Measured: At 24 months after inclusion
Secondary outcomes (12)
Objective response rate
RECIST criteria 1.1 in case of evaluable lesion
Measured: At 24 months after inclusion
Disease control rate
RECIST criteria 1.1 in case of evaluable lesion
Measured: At 24 months after inclusion
Duration of response
The time interval between the first occurrence of partial or complete response according to RECIST criteria and secondary progression (clinic or radiologic)
Measured: Tumor assessment will be done every 2 cycles (1cycle = 28 days), assessed up to 24 months after inclusion
Duration of disease control
The time interval between the first occurrence of disease control (stabilization or partial response or complete response) according to RECIST criteria and secondary progression (clinic or radiologic)
Measured: Tumor assessment will be done every 2 cycles (1 cycle = 28 days), assessed up to 24 months after inclusion
Progression Free Survival (PFS)
In most cases, patient will have a radiologic evaluation and radiologic progression will be defined according to RECIST criteria. In absence of radiologic evaluation (decision of investigator), clinic progression would be defined by investigators according to clinical deterioration of PS, increase of symptoms, and/or increase of tumor markers.
Measured: From inclusion to the date of first event (progression or death) or date of last news if the patient is alive without progression, assessed up to 60 months
Carbohydrate antigen 19-9 (CA-19-9) and carcinoembryonic antigen (CEA) levels
Measured: At baseline (at selection or inclusion visit before starting treatment) and then each 2 cycles (every 8 weeks) until end of treatment, up to 24 months
Toxicities: Type, frequency and severity of adverse events and serious adverse events
Toxicities will be described and grades according to International Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: From inclusion to end of treatment, up to 24 months
Safety: Rate of serious adverse events, grade 3-4 toxicities (hematologic and non-hematologic)
Rate of serious adverse events, grade 3-4 toxicities (hematologic and non-hematologic). Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Measured: From inclusion to end of treatment, up to 24 months
inLongitudinal changes in Quality of life (EORTC QLQ C-30 questionnaire and a consensual geriatric minimum data set (SOFOG) for patients ≥75 years)
Quality of life will be studied by means of the EORTC QLQ C-30 questionnaire (30 questions, score from 30 to 126) and a consensual geriatric minimum data set (SOFOG: 7 questions, score from 0 to 24) for patients ≥75 years at inclusion and at each cycle. A 5-point deterioration in HRQoL scores will be considered as the minimal clinically important difference (MCID). Time until MCID will be analyzed (for each questionnaire) and compared between the two groups. The dynamic change under treatment will be compared at each cycle.
Measured: At inclusion, before starting treatment, and then Day 1 of each cycle (every 4 weeks, 1 cycle = 28 days) until end of treatment, up to 24 months
Dose intensity of each protocol
The dose intensity (DI) of each protocol will be calculated based on the number of cycles received by each patient. The relative DI will be calculated as the ratio of the DI to the DI indicated in the protocol (obtained as the dose specified per cycle in mg/m²)
Measured: During the entire treatment period, up to 24 months
Quality-adjust Time Without Symptoms of disease or Toxicities (Q-TWiST)
The Q-TWiST method combines treatment benefits and risks into a single measure by partitioning survival time into three health states and subsequently assigning quality-of life weights to the survival time in each state. The primary Q-TWiST analysis will be performed using the Intention-to-treat analysis(ITT) population, and will be supplemented with analyses in the per-protocol population (i.e., patients who received ≥80% of the protocol-defined treatment during the first 6 weeks of treatment) and analysed in pre-specified subgroups: age (<75 years, ≥75 years), baseline PS (0-1, 2), liver metastases (Yes, No), and tumour location (head, other).
Measured: During the entire treatment period, up to 24 months
Rate of second and third line
For the patients who will stop the treatment of the protocol (for progression, toxicity or other reason...), we will register the date of beginning and of last administration of each new line of chemotherapy administered during the follow-up.
Measured: From end of study treatment to patient death, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start20 Jul 2020
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste BACHET, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167007
- Sponsor's protocol ID
- D20180177
- Other IDs
- 2019-001364-30, 2019
- Acronym
- GEMFOX
- Status last verified
- Aug 2020
- First submitted
- 28 Aug 2019
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 3 Trial Comparing FOLFOX to Gemcitabine in Metastatic First-line in Patients With Pancreatic Adenocarcinoma and Non-fit for FOLFIRINOX
- ClinicalTrials.gov ID
- NCT04167007
- Acronym / sponsor ID
- GEMFOX / D20180177
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Pancreatic adenocarcinoma, Metastasis, Gemcitabine, FOLFOX, first-line
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 18 Nov 2019 (actual)
- 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.
Pancreatic adenocarcinoma (PAC) incidence increases regularly in Western countries and it is expected to become the second leading cause of cancer-related mortality in 2020. The prognosis of this disease remains very poor with an overall 5-year survival rate less than 5%.
The FOLFIRINOX regimen (5-fluorouracil [5-FU], folinic acid, irinotecan, and oxaliplatin) and the combination of nab-paclitaxel with gemcitabine demonstrated to be more effective than gemcitabine alone, and are both validated as standard first-line treatment options for metastatic PAC. However, the use of FOLFIRINOX is limited to patients with ECOG performance status (PS) 0-1 and aged less than 75 years. Nab-paclitaxel is currently not reimbursed in France.
Detailed description
This trial is an open label, multicenter, randomized phase III trial comparing gemcitabine vs FOLFOX in patients with metastatic pancreatic adenocarcinoma and non-fit for FOLFIRINOX. Adults fulfilling inclusion criteria and non-inclusion criteria will be randomized between a FOLFOX arm and a gemcitabine arm. The primary endpoint is the overall survival (OS) at 24 months. The secondary objectives are : objective response rate and disease control rate (RECIST v1.1, in case of evaluable lesion), duration of response, duration of disease control, progression free survival (PFS), the evolution of biomarkers Ca 19-9 and CEA under treatment, the toxicities according to International Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, the safety of both arms, the quality of life, the dose intensity (DI) of each protocol, the Quality-Adjusted Survival, and the rate and type of second-line / third-line regimens chemotherapy. With an expected median survival time in the control group of 5 months, an accrual period of 3 years and a minimum follow-up period of 2 years, a total of 199 patients per group are required to detect a hazard ratio of 0.75 based on a 5% two-sided type I error rate and a power of 80%, leading to a total number of 400 patients to include.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: GemcitabineGemcitabine at 1000 mg/m² |
| Group II | Active comparator | Drug: FOLFOXOxaliplatin at 85 mg/m² ; Folinic acid 400 mg/m² (racemic form) or 200 mg/m² (L-form) and 5-FU 2400 mg/m² |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Signed and dated informed consent, and willing and able to comply with protocol requirements,
- Histologically or cytologically proven adenocarcinoma of the pancreas,
- In absence of histologically or cytologically proven adenocarcinoma, a cluster of clinical, biological and radiological arguments consistent with the diagnosis: among these, a hypodense pancreatic tumor at CT and a Ca 19-9 greater than 500 UI/ml are essential prerequisites,
- Metastatic disease confirmed (stage IV),
- No prior therapy for metastatic disease (in case of previous adjuvant therapy, interval from end of chemotherapy and relapse must be >12 months),
Key exclusion criteria (20 listed)
- History or evidence upon physical examination of CNS metastasis unless adequately treated (e.g. non irradiated CNS metastasis, seizure not controlled with standard medical therapy),
- Local or locally advanced disease (stage I to III),
- Patient uses warfarin,
- Patient receiving concomitant radiotherapy,
- Electrolytic report uncontrolled: hypercalcemia and/or hypokalemia and/or hypomagnesemia,
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 |
|---|---|---|
| GemcitabineGemcitabine at 1000 mg/m² as intravenous (IV) infusion over 30-40 minutes on days 1, 8, and 15, followed by 1 week of rest, every 28 days | Drug | Group I |
| FOLFOXOxaliplatin at 85 mg/m² given as a 2 hours IV infusion on days 1 and 15; Folinic acid 400 mg/m² (racemic form) or 200 mg/m² (L-form) in 250 ml glucose 5% solution given as a 2 hours IV infusion on days 1 and 15; and 5-FU 2400 mg/m² administered as continuous 46-hour IV infusion on days 1-3 and 15-17, every 28 days. | Drug | Group II |
Primary outcome
Overall survival (OS) at 24 months
Time frame: At 24 months after inclusion
OS will be defined as the delay between the date of inclusion and the date of death (whatever the cause) or the date of last news if the patient is alive.
12 secondary outcomes
Objective response rate
Time frame: At 24 months after inclusion
Disease control rate
Time frame: At 24 months after inclusion
Duration of response
Time frame: Tumor assessment will be done every 2 cycles (1cycle = 28 days), assessed up to 24 months after inclusion
Duration of disease control
Time frame: Tumor assessment will be done every 2 cycles (1 cycle = 28 days), assessed up to 24 months after inclusion
Progression Free Survival (PFS)
Time frame: From inclusion to the date of first event (progression or death) or date of last news if the patient is alive without progression, assessed up to 60 months
Carbohydrate antigen 19-9 (CA-19-9) and carcinoembryonic antigen (CEA) levels
Time frame: At baseline (at selection or inclusion visit before starting treatment) and then each 2 cycles (every 8 weeks) until end of treatment, up to 24 months
Toxicities: Type, frequency and severity of adverse events and serious adverse events
Time frame: From inclusion to end of treatment, up to 24 months
Safety: Rate of serious adverse events, grade 3-4 toxicities (hematologic and non-hematologic)
Time frame: From inclusion to end of treatment, up to 24 months
inLongitudinal changes in Quality of life (EORTC QLQ C-30 questionnaire and a consensual geriatric minimum data set (SOFOG) for patients ≥75 years)
Time frame: At inclusion, before starting treatment, and then Day 1 of each cycle (every 4 weeks, 1 cycle = 28 days) until end of treatment, up to 24 months
Dose intensity of each protocol
Time frame: During the entire treatment period, up to 24 months
Quality-adjust Time Without Symptoms of disease or Toxicities (Q-TWiST)
Time frame: During the entire treatment period, up to 24 months
Rate of second and third line
Time frame: From end of study treatment to patient death, assessed up to 60 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- 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.
Jean-Baptiste BACHET, MD, 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 Phase 3 study testing Gemcitabine and FOLFOX in people with Pancreatic Adenocarcinoma, 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 17 inclusion and 20 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 18 Aug 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jean-Baptiste BACHET, MD, PhD (0142161041 / 0142161045, jean-basptiste.bachet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) at 24 months (time frame: At 24 months after inclusion). 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 18 Aug 2020.