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Neo-adjuvant FOLF(IRIN)OX for Resectable Pancreatic Adenocarcinoma (PANACHE01)

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ClinicalTrials.gov Identifier: NCT02959879
Recruitment Status : Unknown
Verified April 2018 by University Hospital, Rouen.
Recruitment status was:  Recruiting
First Posted : November 9, 2016
Last Update Posted : April 26, 2018
Sponsor:
Collaborators:
UNICANCER
Federation Francophone de Cancerologie Digestive
Federation of Research in Surgery (FRENCH)
GERCOR - Multidisciplinary Oncology Cooperative Group
Information provided by (Responsible Party):
University Hospital, Rouen

Tracking Information
First Submitted Date  ICMJE November 3, 2016
First Posted Date  ICMJE November 9, 2016
Last Update Posted Date April 26, 2018
Actual Study Start Date  ICMJE March 1, 2017
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2016)
  • Number of patients alive [ Time Frame: 12 months ]
    Number of patients alive is evaluated 12 months after the surgery
  • Number of patients who achieved the complete chemotherapy treatment sequences [ Time Frame: 12 months ]
    The number of patients who achieved the complete chemotherapy treatment sequences is evaluated 12 months after the surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2016)
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: through end of treatment, an average of 12 months ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
  • Number of post-operative complications [ Time Frame: 1 month after surgery ]
    Evaluation of post-operative complications is assessed using Dindo Clavien classification
  • Number of patients alive and without recurrence [ Time Frame: 36 months ]
    Number of patients alive is evaluated 36 months after the surgery
  • Number of accomplished R0 resection surgery [ Time Frame: Surgery day ]
    Number of accomplished R0 resection surgery is evaluated by pathologists
  • Evaluation of quality of life [ Time Frame: 4 weeks after the end of chemotherapy treatment ]
    Evaluation of quality of life is done using EORTC QLQ C30
  • Evaluation of quality of life [ Time Frame: 4 weeks after the end of chemotherapy treatment ]
    Evaluation of quality of life is done using EORTC QLQ-PAN26
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 Neo-adjuvant FOLF(IRIN)OX for Resectable Pancreatic Adenocarcinoma
Official Title  ICMJE Resectable Pancreatic Adenocarcinoma Neo-Adjuvant FOLF(IRIN)OX-based CHEmotherapy - A Multicenter, Randomised Phase II Trial (PANACHE01-PRODIGE48 Study)
Brief Summary

In patients with resectable pancreatic duct adenocarcinoma (PDAC), curative surgery followed by adjuvant chemotherapy is currently the standard of care. However, the long-term results are still poor, with median disease-free and overall survival of 14 months and 23 months. The corresponding 5-year overall survival rate is 20%.

Chemotherapy before surgery (neoadjuvant chemotherapy) allows identification of patients with rapidly progressive metastatic disease at time of preoperative restaging (surgery is then avoided in these patients), and may increase the rate of free margin resection (R0) and reduce the risk of local recurrence.

Even though single-agent gemcitabine and 5-FU have been validated in adjuvant and metastatic settings, the objective response was low (at around 10%), whereas combination chemotherapy exceeds a response rate of 30% in advanced disease. In metastatic PDAC, palliative FOLFIRINOX chemotherapy has been demonstrated to be effective (in terms of response rates and progression-free survival) and well tolerated. Interestingly, the response rate is increased by using more than two chemotherapeutic agents in advanced pancreatic cancer, justifying the use of an alternative neoadjuvant FOLFOX-based chemotherapy arm.

PANACHE-01 is an open, non-comparative, randomised, multicentre Phase II study designed to assess the safety and efficacy of two modes of neo-adjuvant chemotherapy (FOLFIRINOX & FOLFOX) relative to the current reference treatment (surgery and then adjuvant chemotherapy) for resectable PDAC.

Patients with immediately resectable PDAC (definition based on the NCCN's (American National Comprehensive Cancer Network 2014) latest guidelines) will be randomised to either pancreatectomy and adjuvant chemotherapy or 4 cycles of neoadjuvant chemotherapy with either FOLFOX or FOLFIRINOX. The patients in the neoadjuvant chemotherapy arms will receive postoperative chemotherapy for 4 months (8 cycles).

Detailed Description Not Provided
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 Resectable Pancreatic Duct Adenocarcinoma
Intervention  ICMJE
  • Drug: FOLFOX neoadjuvant chemotherapy
    4 cycles of FOLFOX neoadjuvant chemotherapy are administrated to patient
  • Drug: FOLFIRINOX neoadjuvant chemotherapy
    4 cycles of FOLFIRINOX neoadjuvant chemotherapy are administrated to patient
  • Procedure: curative surgery for resectable pancreatic duct adenocarcinoma
    curative surgery for resectable pancreatic duct adenocarcinoma
  • Drug: Standard adjuvant chemotherapy
    12 cycles of standard adjuvant chemotherapy are administrated
  • Drug: adjuvant chemotherapy
    8 cycles of standard adjuvant chemotherapy are administrated
Study Arms  ICMJE
  • Experimental: FOLFOX neoadjuvant chemotherapy
    4 cycles of FOLFOX neoadjuvant chemotherapy are administrated to patient. Curative surgery for resectable pancreatic duct adenocarcinoma will be done after neoadjuvant chemotherapy. 8 cycles of adjuvant chemotherapy are administrated following the surgery
    Interventions:
    • Drug: FOLFOX neoadjuvant chemotherapy
    • Procedure: curative surgery for resectable pancreatic duct adenocarcinoma
    • Drug: adjuvant chemotherapy
  • Experimental: FOLFIRINOX neoadjuvant chemotherapy
    4 cycles of FOLFIRINOX neoadjuvant chemotherapy are administrated to patient. Curative surgery for resectable pancreatic duct adenocarcinoma will be done after neoadjuvant chemotherapy. 8 cycles of adjuvant chemotherapy are administrated following the surgery
    Interventions:
    • Drug: FOLFIRINOX neoadjuvant chemotherapy
    • Procedure: curative surgery for resectable pancreatic duct adenocarcinoma
    • Drug: adjuvant chemotherapy
  • Active Comparator: standard adjuvant chemotherapy

    Curative surgery for resectable pancreatic duct adenocarcinoma will be done after randomization.

    12 cycles of standard adjuvant chemotherapy are administrated following the surgery

    Interventions:
    • Procedure: curative surgery for resectable pancreatic duct adenocarcinoma
    • Drug: Standard adjuvant chemotherapy
Publications * Schwarz L, Vernerey D, Bachet JB, Tuech JJ, Portales F, Michel P, Cunha AS. Resectable pancreatic adenocarcinoma neo-adjuvant FOLF(IRIN)OX-based chemotherapy - a multicenter, non-comparative, randomized, phase II trial (PANACHE01-PRODIGE48 study). BMC Cancer. 2018 Jul 24;18(1):762. doi: 10.1186/s12885-018-4663-4. Erratum in: BMC Cancer. 2020 Mar 3;20(1):168.

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 7, 2016)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histology-proven, adenocarcinoma of the pancreas.
  • Resectable adenocarcinoma (according to the NCCN classification 2014): absence of distant organ or distal lymph node metastases, absence of evidence of superior mesenteric vein (SMV) and portal vein distortion, tumour thrombus, or venous encasement, the existence of clear fat planes around the celiac axis, hepatic artery and superior mesenteric artery (SMA). Resectability is evaluated on arterial-phase and portal-phase IV contrast-enhanced multislice CT-scan of the pancreas (slice thickness: 2.5 mm), as evaluated in a multidisciplinary staff meeting including at least one radiologist and one expert surgeon.
  • No prior chemotherapy.
  • Age 18 years or over.
  • Ability to understand and willingness to consent to formal requirements for study participation
  • Provision of written informed consent prior to any study-specific screening procedures.

Exclusion Criteria:

  • PDAC defined as "borderline", locally advanced, non-resectable or metastatic.
  • Prior cancer therapy for PDAC
  • Surgical or anaesthesiological contra-indications: non-controlled congestive heart failure - non-treated angina - recent myocardial infarction (in the previous year) - non-controlled arterial hypertension (SBP >160 mm or DBP > 100 mm, despite optimal drug treatment), long QT, major non-controlled infection, severe liver failure.
  • Any medical, psychological or social situation that (in the investigator's opinion) could limit (i) the patient's compliance with the protocol or (ii) the ability to obtain or interpret data.
  • Pregnant or breastfeeding women and women of child-bearing age not using effective means of contraception.
  • History or current evidence on physical examination of central nervous system disease or peripheral neuropathy ≥ grade 1, according to according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.0.
  • Known hypersensitivity reaction to any of the components of study treatments.
  • Pregnancy (the absence of which must be confirmed in a ß-hCG test) or breast-feeding.
  • Any significant disease which, in the investigator's opinion, would exclude the patient from the study.
  • Patients having been included in a clinical trial within the previous 4 weeks or participating in another trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02959879
Other Study ID Numbers  ICMJE 2014/210/HP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University Hospital, Rouen
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Rouen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • UNICANCER
  • Federation Francophone de Cancerologie Digestive
  • Federation of Research in Surgery (FRENCH)
  • GERCOR - Multidisciplinary Oncology Cooperative Group
Investigators  ICMJE
Principal Investigator: Lilian SCHWARZ, MD Rouen University Hospital
PRS Account University Hospital, Rouen
Verification Date April 2018

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