Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44)

NCT02676349 | Completed Phase 2 DMC

• 1 other identifier: 2014-005681-29
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 26

Brief Summary

This is a prospective, randomized phase II trial. The aim of this study is to assess the efficacy of two therapeutics strategies. Patients with borderline-resectable pancreatic cancer (BRPC) will be randomly in two arms : neoadjuvant mFolfirinox followed with or without preoperative chemoradiotherapy with capecitabine.

Conditions

Pancreatic Carcinoma

Keywords

mFolfirinox; Chemoradiotherapy; Neoadjuvant treatment; Borderline

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy of two neoadjuvant therapies in patients with borderline resectable pancreatic carcinoma evaluated on histological R0 resection margin rate

  up to 7.5 months

Secondary Outcomes (11)

• Evaluate the toxicities associated with chemotherapy and chemoradiotherapy

  up to 7 years

• Evaluate the proportion of resected patients

  up to 7.5 months

• Evaluate the response rate to chemotherapy and chemoradiotherapy

  up to 7.5 months

• Evaluate the histological complete response rate in resected patients.

  up to 7.5 months

• Evaluate the perioperative mortality rate

  up to 8.5 months

Study Arms (2)

Arm B

EXPERIMENTAL

Neoadjuvant chemotherapy with mFolfirinox regimen + concomitant chemoradiotherapy + surgery + adjuvant chemotherapy

Drug: mFolfirinox; Radiation: Chemoradiotherapy; Procedure: surgery; Drug: Adjuvant chemotherapy

Arm A

ACTIVE COMPARATOR

Neoadjuvant chemotherapy with mFolfirinox regimen + surgery + adjuvant chemotherapy

Drug: mFolfirinox; Procedure: surgery; Drug: Adjuvant chemotherapy

Interventions

mFolfirinox DRUG

oxaliplatin folinic acid irinotecan 5FU oxaliplatin

Arm A; Arm B

Chemoradiotherapy RADIATION

conformational external irradiation (50.4 Gy) + capecitabine

Arm B

surgery PROCEDURE

1 to 4 weeks after neoadjuvant treatment according to tumour response

Arm A; Arm B

Adjuvant chemotherapy DRUG

Gemcitabine or modified LV5FU (folinic acid+-bolus fluorouracil+ infusional fluorouracil)

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG performance status 0 or 1
• Adult patients ≥ 18 years and ≤ 75 years of age
• Histologic or cytologic proven adenocarcinoma of the pancreas (histologic confirmation of diagnosis is preferred)
• Confirmation by independent multidisciplinary expert review of borderline resectable status, according to NCCN-Clinical Practice Guidelines in Oncology "pancreatic adenocarcinoma", version 1.2015.
• Adequate hematologic function, as follows:
• absolute neutrophil count (ANC) ≥ \> 2000/mm3
• platelet count ≥ 100 000/mm3
• haemoglobin ≥ 10 g/dL
• Adequate renal, hepatic and bone marrow function, defined as:
• Calculated creatinine clearance ≥ 50 mL/min according to MDRD formula
• Serum total bilirubin ≤ 1.5 times the institutional upper limit of normal. Patients with a biliary short metal stent due to cancer obstruction may be included provided that high-quality imaging is performed before stenting and bilirubin level after stent insertion decreased to ≤ 20 mg/L (≤ 34 µmol/l), and there is no cholangitis.
• Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, combined oral contraceptives, some intrauterine devices \[IUDs\], sexual abstinence, or sterilized partner)
• for male subject: during the treatment and for up to 6 months after the last dose of oxaliplatin or up to 3 months after the last dose of irinotcan.
• for female subject: during the treatment and for up to 4 months after the last dose of oxaliplatin or up to 3 months after the last dose of irinotcan.
• Ability to provide written informed consent before the start of any study specific procedures

You may not qualify if:

• Any previous treatment of the pancreatic cancer except biliary short metal stenting (chemotherapy, targeted tumor therapy, local ablative therapy, previous irradiation within the actual fields of planned radiotherapy)
• Evidence of distant metastases including ascites
• Evidence of extent of pancreatic cancer beyond that defined as "borderline resectable" : suspicious lymphadenopathy outside of the standard field of resection (i.e., aortocaval nodes, distant abdominal nodes)
• Contraindication for pancreas resection
• Pregnant or breast feeding females
• Patients with known Gilbert's Syndrome or homozygosity for UGT1A1\*28 polymorphism
• Uracilemia ≥ 16ng/mL either a partial or complete deficiency in dihydropyrimidine dehydrogenase (DPD)
• Participation in any other clinical trial or treatment with any experimental drug within 28 days before enrolment to the study or during study participation until the end of treatment visit that can be interfering with the objectives of the study
• Previous or concurrent malignant tumor disease other than underlying tumor disease (with the exception of cervical cancer in situ, adequately treated non-melanoma skin cancers, superficial bladder tumors (Ta, Tis, and T1) or any curatively treated without chemotherapy and favourable prognosis tumors without evidence of disease for \> 3 years prior to enrolment)
• Any severe and/or uncontrolled medical conditions including but not limited to:
• Clinically significant cardiovascular or vascular disease : angina pectoris (even controlled), previous myocardial infarction, serious uncontrolled cardiac arrhythmia, chronic heart failure, acute or chronic infectious disease requiring general treatment)
• Acute and chronic, active infectious disorders that requires systemic treatment
• Peripheral polyneuropathy \> grade 1
• Any previous inflammatory disease of colon or rectum
• Any other severe concomitant disease or disorder, which could influence patient's ability to participate in the study and his/her safety during the study e.g. severe hepatic, renal, pulmonary, metabolic, or psychiatric disorders

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (26)

Institut Bergonié

Bordeaux, France

Location

Polyclinique Bordeaux Nord

Bordeaux, France

Location

Hôpital Beaujon

Clichy, 92110, France

Location

Chu Colmar

Colmar, France

Location

Hôpital Henri Mondor (APHP)

Créteil, France

Location

Centre Oscar Lambret

Lille, France

Location

Chru Lille

Lille, France

Location

Infirmerie Protestante de Lyon

Lyon, France

Location

Hôpital Européen Marseille

Marseille, France

Location

Hôpital La Timone

Marseille, France

Location

Institut Paoli CALMETTES

Marseille, France

Location

Institut du Cancer de Montpellier

Montpellier, France

Location

Chu Nantes

Nantes, France

Location

Hôpital Cochin (APHP)

Paris, France

Location

Institut Mutualiste Montsouris

Paris, France

Location

Pitié Salpêtrière (APHP)

Paris, France

Location

Hôpital Haut-Lévêque

Pessac, France

Location

CHU Reims

Reims, France

Location

Centre Eugène Marquis

Rennes, France

Location

Chu Rouen

Rouen, France

Location

CHP Saint Grégoire

Saint-Grégoire, France

Location

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

Location

Chru Tours

Tours, France

Location

Chru Nancy

Vandœuvre-lès-Nancy, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Location

Hôpital Paul Brousse

Villejuif, 94804, France

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Chemoradiotherapy; Surgical Procedures, Operative; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Thierry CONROY, Pr

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

• Jean-Baptiste BACHET, Pr

  Groupe Hospitalier Pitié-Salpêtrière

  STUDY CHAIR

• Pascal HAMMEL, Pr

  Hôpital Paul Brousse - Hôpitaux de Paris (AP-HP)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 8, 2016
• Study Start: October 13, 2016
• Primary Completion: April 19, 2024
• Study Completion: December 1, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (26)