Trial record 1 of 8 for:
PRODIGE 29
A Randomized Phase III Trial Comparing Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma (NEOPAN)
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| ClinicalTrials.gov Identifier: NCT02539537 |
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Recruitment Status :
Active, not recruiting
First Posted : September 3, 2015
Last Update Posted : March 7, 2023
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Sponsor:
UNICANCER
Information provided by (Responsible Party):
UNICANCER
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Brief Summary:
French national multicentric phase III trial evaluating chemotherapy with Folfirinox or gemcitabine in locally advanced pancreatic carcinoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pancreatic Cancer Carcinoma | Drug: Gemcitabine Drug: Folinic Acid Drug: 5-Fluoro-uracil Drug: Oxaliplatin Drug: Irinotecan Drug: L-folinic | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 171 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Phase III Trial Comparing Chemotherapy With Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma |
| Actual Study Start Date : | March 23, 2015 |
| Actual Primary Completion Date : | February 2022 |
| Estimated Study Completion Date : | January 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Pancreatic Cancer
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm A: Gemcitabine
Gemcitabine 1000 mg/m² IV infusion over 30 minutes on D1 of each week for the 4 weeks of the first cycle (1 cycle = 4 weeks). For the following five cycles, gemcitabine infusion on D1, D8, and D15 of each cycle, followed by 1 week without injection (i.e. in total 4 cycles over 24 weeks; with 19 administrations of Gemcitabine).
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Drug: Gemcitabine |
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Experimental: Arm B: Folfirinox
Administered once every 14 days for 24 weeks (12 cycles). A cycle equals 14 days with injection on D1 of each cycle. Treatment starts with oxaliplatin (85 mg/m²) administration; IV infusion over 2 hours, followed by the simultaneous administration (using a Y-tubing) of folinic acid 400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) IV infusion over 2 hours and irinotecan 180 mg/m² IV infusion over 90 minutes. The irinotecan will begin 30 minutes after the start of the folinic acid infusion. 5-Fluoro-uracil (5-FU) IV 2,400 mg/m²/h will be administered over 46 hours after the end of the folinic acid infusion, i.e. 1200 mg/m²/day for the duration of 2 days. Treatment will be continued for 24 weeks (12 cycles). |
Drug: Folinic Acid Drug: 5-Fluoro-uracil Drug: Oxaliplatin Drug: Irinotecan Drug: L-folinic |
Primary Outcome Measures :
- Progression-Free-Survival (PFS) [ Time Frame: From randomization until disease progression or date of death, assessed up until to 128 weeks ]To compare Progression-Free-Survival (PFS) between the two treatment arms
Secondary Outcome Measures :
- Composite index for treatment early severe toxicity [ Time Frame: First four chemotherapy cycles, 16 weeks ]Biliary tract infection Grade 3-4 + any grade 5 toxicities + chemotherapy interruption for toxicity during the first four cycles.
- Adverse events (NCI-CTCAE version 4.0); observance of chemotherapy [ Time Frame: During treatment phase, 24 weeks ]Observance of chemotherapy
- Overall Survival [ Time Frame: Until death, assessed up 128 weeks after randomization ]The overall survival is the length of time from randomization that patients enrolled in the study are still alive. The outcome is to evaluate whether SRBT improves overall survival compared to standard of care.
- Progression-free survival: pattern of failure [ Time Frame: Until Disease Progression, assessed uo until 128 weeks after randomization ]The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.
- Percentage of secondarily curative-intent surgery [ Time Frame: Until surgery, if applicable, up until 128 weeks after randomization ]Percentage of patients who will undergo an exeresis of their pancreatic tumor, with R0 resection confirmed by anatomopathic pathology.
- Objective tumour response, disease control and their duration [ Time Frame: Until disease progression or date of death, assessed up until 128 weeks after randomization ]Objective tumour response, disease control and their duration (RECIST version 1.1),
- Time to treatment failure [ Time Frame: From randomisation to the end of treatment ]Time to treatment failure
- Quality of life questionnaire - Core 30 (QLQ-C30) [ Time Frame: assessed up until 128 weeks after randomization ]Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Proven unresectability after multidisciplinary discussion involving radiologist and a surgeon
- Locally advanced (i.e.: no metastasis or suspicion of metastasis) and unresectable tumors: for example mesenteric or portal vein involvement, or > 180° encasement of the superior mesenteric artery, or celiac abutment (NCCN 2012 criteria)
- Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST 1.1
- WHO Performance status (PS) 0-1
- Age ≥18 years
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Patient with organ function as follows:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
- Hemoglobin ≥ 10 g/dL
- Platelets (PTL) ≥ 75 x 10⁹/L
- Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
- Bilirubin ≤ 1.5 x ULN
- Creatinine ≤ 2 x ULN
- Albumin > 0.75 x lower limit of normal (LLN)
- Urea ≤ 2 x ULN
- Adequate vital functions
- Patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use medically acceptable methods of contraception during the study and for 4 months after the last intake of study treatment for women and for 6 months after for men.
- Patient information and signed informed consent form
- Public or private health insurance coverage
- Uracilemia < 16 ng/ml
Exclusion Criteria:
- Patient treated for a cancer other than pancreatic cancer within 5 years before enrolment, with the exception of basal cell carcinoma or in situ cervical cancer
- Patient with metastasis or with history of metastasis
- Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e. congestive heart failure, myocardial infarction within 6 months before baseline)
- Major comorbidity, active infection (HIV or chronic hepatitis B or C) or uncontrolled diabetes that may preclude the delivery of the treatment
- Pre-existing neuropathy (Grade ≥ 2), Gilbert's disease or genotype UGT1A1 * 28 / * 28
- Pregnant woman
- Fructose intolerance
- Patients currently treated by warfarin
- Persons deprived of liberty or under guardianship
- Psychological condition, family-, sociological- or geographical situation potentially hampering compliance with the study protocol and the follow-up schedule
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539537
Locations
Show 45 study locations
Sponsors and Collaborators
UNICANCER
Investigators
| Principal Investigator: | Michel DUCREUX, Professor | Gustave Roussy, Cancer Campus, Grand Paris |
| Responsible Party: | UNICANCER |
| ClinicalTrials.gov Identifier: | NCT02539537 |
| Other Study ID Numbers: |
PRODIGE 29 (UCGI 26) 2014-003510-82 ( EudraCT Number ) |
| First Posted: | September 3, 2015 Key Record Dates |
| Last Update Posted: | March 7, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement. |
| Access Criteria: | Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by UNICANCER:
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locally advanced pancreatic carcinoma FOLFIRINOX |
Additional relevant MeSH terms:
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Carcinoma Pancreatic Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Leucovorin Folic Acid Gemcitabine Fluorouracil |
Oxaliplatin Irinotecan Levoleucovorin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Antidotes Protective Agents Physiological Effects of Drugs Vitamin B Complex Vitamins |