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Trial record 1 of 1 for:    panache
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Neo-adjuvant FOLF(IRIN)OX for Resectable Pancreatic Adenocarcinoma (PANACHE01)

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ClinicalTrials.gov Identifier: NCT02959879
Recruitment Status : 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

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).


Condition or disease Intervention/treatment Phase
Resectable Pancreatic Duct Adenocarcinoma Drug: FOLFOX neoadjuvant chemotherapy Drug: FOLFIRINOX neoadjuvant chemotherapy Procedure: curative surgery for resectable pancreatic duct adenocarcinoma Drug: Standard adjuvant chemotherapy Drug: adjuvant chemotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Resectable Pancreatic Adenocarcinoma Neo-Adjuvant FOLF(IRIN)OX-based CHEmotherapy - A Multicenter, Randomised Phase II Trial (PANACHE01-PRODIGE48 Study)
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
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
Drug: FOLFOX neoadjuvant chemotherapy
4 cycles of FOLFOX neoadjuvant chemotherapy are administrated to patient

Procedure: curative surgery for resectable pancreatic duct adenocarcinoma
curative surgery for resectable pancreatic duct adenocarcinoma

Drug: adjuvant chemotherapy
8 cycles of standard adjuvant chemotherapy are administrated

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
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: adjuvant chemotherapy
8 cycles of standard adjuvant chemotherapy are administrated

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

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




Primary Outcome Measures :
  1. Number of patients alive [ Time Frame: 12 months ]
    Number of patients alive is evaluated 12 months after the surgery

  2. 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


Secondary Outcome Measures :
  1. 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

  2. Number of post-operative complications [ Time Frame: 1 month after surgery ]
    Evaluation of post-operative complications is assessed using Dindo Clavien classification

  3. Number of patients alive and without recurrence [ Time Frame: 36 months ]
    Number of patients alive is evaluated 36 months after the surgery

  4. Number of accomplished R0 resection surgery [ Time Frame: Surgery day ]
    Number of accomplished R0 resection surgery is evaluated by pathologists

  5. 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

  6. 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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT02959879


Contacts
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Contact: Lilian SCHWARZ, MD +3323288 ext 8265 lilian.schwarz@chu-rouen.fr
Contact: Julien BLOT julien.blot@chu-rouen.fr

Locations
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France
Rouen University Hospital Recruiting
Rouen, France
Contact: Lilian SCHWARZ, MD         
Principal Investigator: Lilian SCHWARZ, MD         
Sponsors and Collaborators
University Hospital, Rouen
UNICANCER
Federation Francophone de Cancerologie Digestive
Federation of Research in Surgery (FRENCH)
GERCOR - Multidisciplinary Oncology Cooperative Group
Investigators
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Principal Investigator: Lilian SCHWARZ, MD Rouen University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02959879    
Other Study ID Numbers: 2014/210/HP
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Rouen:
FOLFOX
FOLFIRINOX
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma, Ductal
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Ductal, Lobular, and Medullary
Folfirinox
Antineoplastic Agents