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

Primary Purpose

Resectable Pancreatic Duct Adenocarcinoma

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

FOLFOX neoadjuvant chemotherapy

FOLFIRINOX neoadjuvant chemotherapy

curative surgery for resectable pancreatic duct adenocarcinoma

Standard adjuvant chemotherapy

adjuvant chemotherapy

About this trial

This is an interventional treatment trial for Resectable Pancreatic Duct Adenocarcinoma focused on measuring FOLFOX, FOLFIRINOX

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rouen University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

FOLFOX neoadjuvant chemotherapy

FOLFIRINOX neoadjuvant chemotherapy

standard adjuvant chemotherapy

Arm Description

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

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

Curative surgery for resectable pancreatic duct adenocarcinoma will be done after randomization. 12 cycles of standard adjuvant chemotherapy are administrated following the surgery

Outcomes

Primary Outcome Measures

Number of patients alive

Number of patients alive is evaluated 12 months after the surgery

Number of patients who achieved the complete chemotherapy treatment sequences

The number of patients who achieved the complete chemotherapy treatment sequences is evaluated 12 months after the surgery

Secondary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Number of post-operative complications

Evaluation of post-operative complications is assessed using Dindo Clavien classification

Number of patients alive and without recurrence

Number of patients alive is evaluated 36 months after the surgery

Number of accomplished R0 resection surgery

Number of accomplished R0 resection surgery is evaluated by pathologists

Evaluation of quality of life

Evaluation of quality of life is done using EORTC QLQ C30

Evaluation of quality of life

Evaluation of quality of life is done using EORTC QLQ-PAN26

Full Information

NCT ID

NCT02959879

First Posted

November 3, 2016

Last Updated

April 24, 2018

Sponsor

University Hospital, Rouen

Collaborators

UNICANCER, Federation Francophone de Cancerologie Digestive, Federation of Research in Surgery (FRENCH), GERCOR - Multidisciplinary Oncology Cooperative Group

1. Study Identification

Unique Protocol Identification Number

NCT02959879

Brief Title

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

Acronym

PANACHE01

Official Title

Resectable Pancreatic Adenocarcinoma Neo-Adjuvant FOLF(IRIN)OX-based CHEmotherapy - A Multicenter, Randomised Phase II Trial (PANACHE01-PRODIGE48 Study)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Rouen

Collaborators

UNICANCER, Federation Francophone de Cancerologie Digestive, Federation of Research in Surgery (FRENCH), GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Resectable Pancreatic Duct Adenocarcinoma

Keywords

FOLFOX, FOLFIRINOX

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FOLFOX neoadjuvant chemotherapy

Arm Type

Experimental

Arm Description

Arm Title

FOLFIRINOX neoadjuvant chemotherapy

Arm Type

Experimental

Arm Description

Arm Title

standard adjuvant chemotherapy

Arm Type

Active Comparator

Arm Description

Curative surgery for resectable pancreatic duct adenocarcinoma will be done after randomization. 12 cycles of standard adjuvant chemotherapy are administrated following the surgery

Intervention Type

Drug

Intervention Name(s)

FOLFOX neoadjuvant chemotherapy

Intervention Description

4 cycles of FOLFOX neoadjuvant chemotherapy are administrated to patient

Intervention Type

Drug

Intervention Name(s)

FOLFIRINOX neoadjuvant chemotherapy

Intervention Description

4 cycles of FOLFIRINOX neoadjuvant chemotherapy are administrated to patient

Intervention Type

Procedure

Intervention Name(s)

curative surgery for resectable pancreatic duct adenocarcinoma

Intervention Description

curative surgery for resectable pancreatic duct adenocarcinoma

Intervention Type

Drug

Intervention Name(s)

Standard adjuvant chemotherapy

Intervention Description

12 cycles of standard adjuvant chemotherapy are administrated

Intervention Type

Drug

Intervention Name(s)

adjuvant chemotherapy

Intervention Description

8 cycles of standard adjuvant chemotherapy are administrated

Primary Outcome Measure Information:

Title

Number of patients alive

Description

Number of patients alive is evaluated 12 months after the surgery

Time Frame

12 months

Title

Number of patients who achieved the complete chemotherapy treatment sequences

Description

The number of patients who achieved the complete chemotherapy treatment sequences is evaluated 12 months after the surgery

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Description

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

Title

Number of post-operative complications

Description

Evaluation of post-operative complications is assessed using Dindo Clavien classification

Time Frame

1 month after surgery

Title

Number of patients alive and without recurrence

Description

Number of patients alive is evaluated 36 months after the surgery

Time Frame

36 months

Title

Number of accomplished R0 resection surgery

Description

Number of accomplished R0 resection surgery is evaluated by pathologists

Time Frame

Surgery day

Title

Evaluation of quality of life

Description

Evaluation of quality of life is done using EORTC QLQ C30

Time Frame

4 weeks after the end of chemotherapy treatment

Title

Evaluation of quality of life

Description

Evaluation of quality of life is done using EORTC QLQ-PAN26

Time Frame

4 weeks after the end of chemotherapy treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lilian SCHWARZ, MD

Phone

+3323288

Ext

8265

lilian.schwarz@chu-rouen.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Julien BLOT

julien.blot@chu-rouen.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lilian SCHWARZ, MD

Organizational Affiliation

Rouen University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rouen University Hospital

City

Rouen

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lilian SCHWARZ, MD

First Name & Middle Initial & Last Name & Degree

Lilian SCHWARZ, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30041614

Citation

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.

Results Reference

derived

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

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