Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    2014-005681-29
Previous Study | Return to List | Next Study

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

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: NCT02676349
Recruitment Status : Recruiting
First Posted : February 8, 2016
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de Lorraine

Tracking Information
First Submitted Date  ICMJE February 3, 2016
First Posted Date  ICMJE February 8, 2016
Last Update Posted Date April 3, 2019
Actual Study Start Date  ICMJE October 13, 2016
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
To assess the efficacy of two neoadjuvant therapies in patients with borderline resectable pancreatic carcinoma evaluated on histological R0 resection margin rate [ Time Frame: up to 7.5 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02676349 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
  • Evaluate the toxicities associated with chemotherapy and chemoradiotherapy [ Time Frame: up to 7 years ]
  • Evaluate the proportion of resected patients [ Time Frame: up to 7.5 months ]
  • Evaluate the response rate to chemotherapy and chemoradiotherapy [ Time Frame: up to 7.5 months ]
  • Evaluate the histological complete response rate in resected patients. [ Time Frame: up to 7.5 months ]
  • Evaluate the perioperative mortality rate [ Time Frame: up to 8.5 months ]
  • Evaluate the perioperative morbidity rate [ Time Frame: up to 8.5 months ]
  • Evaluate the overall survival [ Time Frame: up to 7 years ]
  • Evaluate the quality of life [ Time Frame: up to 7.5 months ]
  • Evaluate the loco-regional relapse-free survival [ Time Frame: 7 years ]
  • Evaluate the metastatic Progression Free Survival [ Time Frame: 7 years ]
  • Evaluate the progression-free survival [ Time Frame: 7 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44)
Official Title  ICMJE Two Arm, Prospective, Multicenter Randomized Phase II Trial of Neoadjuvant Modified Folfirinox Regimen, With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma
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.
Detailed Description

Surgery, especially if followed by adjuvant chemotherapy, offers the only chance of cure of pancreatic cancer. At first diagnosis, after careful assessment, only 10 to 15% of patients are considered to be candidates for surgical resection and about 7% have a potentially resectable disease. These potentially resectable tumors called "borderline resectable pancreatic cancer" (BRPC) are conceptualized as those that involve the mesenteric vasculature to a limited extent and those for which resection, while possible, would likely be compromised by positive surgical margins (R1) in the absence of neoadjuvant treatment. R0 resection is indeed considered as an independent prognostic factor for survival when the surgical procedures, histological examination and definition of microscopic invasion are standardized.

The objectives of neoadjuvant treatments of BRPC is to reduce tumor volume before surgery in order to improve the chances of radical (R0) resection and to reduce the rate of lymph node positivity and recurrences. The primary outcome in published studies is usually R0 resection rate, but these results also depend on the number of margins examined and the definition of microscopic margin involvement. Prospective studies with consistent selection criteria and standardized assessment criteria are needed.

Different neoadjuvant therapeutic strategies have been tested in pilot studies: preoperative chemoradiotherapy or neoadjuvant chemotherapy, followed or not by a preoperative (chemo)radiotherapy. Due to the lack of randomized studies, the best sequence of treatment administration has not been established.

The aim of this prospective, randomized, multicenter, trial is to evaluate the R0 resection rate with neoadjuvant Folfirinox, followed or not by radiochemotherapy for patients with borderline resectable pancreatic cancers.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Carcinoma
Intervention  ICMJE
  • Drug: mFolfirinox
    oxaliplatin folinic acid irinotecan 5FU oxaliplatin
  • Radiation: Chemoradiotherapy
    conformational external irradiation (50.4 Gy) + capecitabine
  • Procedure: surgery
    1 to 4 weeks after neoadjuvant treatment according to tumour response
  • Drug: Adjuvant chemotherapy
    Gemcitabine or modified LV5FU (folinic acid+-bolus fluorouracil+ infusional fluorouracil)
Study Arms  ICMJE
  • Experimental: Arm B
    Neoadjuvant chemotherapy with mFolfirinox regimen + concomitant chemoradiotherapy + surgery + adjuvant chemotherapy
    Interventions:
    • Drug: mFolfirinox
    • Radiation: Chemoradiotherapy
    • Procedure: surgery
    • Drug: Adjuvant chemotherapy
  • Active Comparator: Arm A
    Neoadjuvant chemotherapy with mFolfirinox regimen + surgery + adjuvant chemotherapy
    Interventions:
    • Drug: mFolfirinox
    • Procedure: surgery
    • Drug: Adjuvant chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 3, 2016)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2026
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • Patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study.

Exclusion Criteria:

  • 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
  • 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
  • Hypersensitivity against any of the study drugs (gemcitabine, oxaliplatin, irinotecan, 5-fluorouracil, folinic acid), or the ingredients of these drugs (e.g. fructose).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jen Louis MERLIN, Md PharmaD 03 83 59 83 07 jl.merlin@nancy.unicancer.fr
Contact: Laurinda FERNANDES 03 83 59 84 87 l.fernandes@nancy.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02676349
Other Study ID Numbers  ICMJE 2014-005681-29
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut de Cancérologie de Lorraine
Study Sponsor  ICMJE Institut de Cancérologie de Lorraine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thierry CONROY, Pr Institut de Cancérologie de Lorraine
Study Chair: Jean-Baptiste BACHET, Dr Groupe Hospitalier Pitié Salpêtrière
Study Chair: Pascal HAMMEL, Pr Hôpital Beaujon Assistance Publique - Hôpitaux de Paris (AP-HP)
PRS Account Institut de Cancérologie de Lorraine
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP