A Randomized Phase III Trial Comparing Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma (NEOPAN)
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|ClinicalTrials.gov Identifier: NCT02539537|
Recruitment Status : Recruiting
First Posted : September 3, 2015
Last Update Posted : March 24, 2021
|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)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2024|
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).
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
- 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
- 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.
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
|Contact: Nicolas DE SOUSA CARVALHO||+33 (0)1 71 93 67 firstname.lastname@example.org|
|Principal Investigator:||Michel DUCREUX, Professor||Gustave Roussy, Cancer Campus, Grand Paris|