A Randomized Phase III Trial Comparing Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma (NEOPAN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02539537|
Recruitment Status : Recruiting
First Posted : September 3, 2015
Last Update Posted : December 4, 2019
|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 :||March 2021|
|Estimated Study Completion Date :||March 2022|
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 min. The irinotecan will begin 30 min. 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 ]
- Progression-free survival: pattern of failure [ Time Frame: Until Disease Progression, assessed uo until 128 weeks after randomization ]
- Percentage of secondarily curative-intent surgery [ Time Frame: Until surgery, if applicable, up until 128 weeks after randomization ]
- 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: Until disease progression, assessed up until 128 weeks after randomization ]
- Quality of life (QLQ C30) [ Time Frame: assessed up until 128 weeks after randomization ]
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: Laure MONARD||+33 (0)1 73 79 73 firstname.lastname@example.org|
|Principal Investigator:||Michel DUCREUX, Professor||Gustave Roussy, Cancer Campus, Grand Paris|