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NCT02959879 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2026-02-06

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
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.
healthy Volunteers
false
maximum Age
85 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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
    intervention Names
    1. Drug: FOLFOX neoadjuvant chemotherapy
    2. Procedure: curative surgery for resectable pancreatic duct adenocarcinoma
    3. Drug: adjuvant chemotherapy
    label
    FOLFOX neoadjuvant chemotherapy
    type
    EXPERIMENTAL
  2. description
    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
    intervention Names
    1. Drug: FOLFIRINOX neoadjuvant chemotherapy
    2. Procedure: curative surgery for resectable pancreatic duct adenocarcinoma
    3. Drug: adjuvant chemotherapy
    label
    FOLFIRINOX neoadjuvant chemotherapy
    type
    EXPERIMENTAL
  3. 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 Names
    1. Procedure: curative surgery for resectable pancreatic duct adenocarcinoma
    2. Drug: Standard adjuvant chemotherapy
    label
    standard adjuvant chemotherapy
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. FOLFOX neoadjuvant chemotherapy
    description
    4 cycles of FOLFOX neoadjuvant chemotherapy are administrated to patient
    name
    FOLFOX neoadjuvant chemotherapy
    type
    DRUG
  2. arm Group Labels
    1. FOLFIRINOX neoadjuvant chemotherapy
    description
    4 cycles of FOLFIRINOX neoadjuvant chemotherapy are administrated to patient
    name
    FOLFIRINOX neoadjuvant chemotherapy
    type
    DRUG
  3. arm Group Labels
    1. FOLFIRINOX neoadjuvant chemotherapy
    2. FOLFOX neoadjuvant chemotherapy
    3. standard adjuvant chemotherapy
    description
    curative surgery for resectable pancreatic duct adenocarcinoma
    name
    curative surgery for resectable pancreatic duct adenocarcinoma
    type
    PROCEDURE
  4. arm Group Labels
    1. standard adjuvant chemotherapy
    description
    12 cycles of standard adjuvant chemotherapy are administrated
    name
    Standard adjuvant chemotherapy
    type
    DRUG
  5. arm Group Labels
    1. FOLFIRINOX neoadjuvant chemotherapy
    2. FOLFOX neoadjuvant chemotherapy
    description
    8 cycles of standard adjuvant chemotherapy are administrated
    name
    adjuvant chemotherapy
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
153
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Number of patients alive is evaluated 12 months after the surgery
    measure
    Number of patients alive
    time Frame
    12 months
  2. description
    The number of patients who achieved the complete chemotherapy treatment sequences is evaluated 12 months after the surgery
    measure
    Number of patients who achieved the complete chemotherapy treatment sequences
    time Frame
    12 months
secondary Outcomes
  1. description
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
    measure
    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
  2. description
    Evaluation of post-operative complications is assessed using Dindo Clavien classification
    measure
    Number of post-operative complications
    time Frame
    1 month after surgery
  3. description
    Number of patients alive is evaluated 36 months after the surgery
    measure
    Number of patients alive and without recurrence
    time Frame
    36 months
  4. description
    Number of accomplished R0 resection surgery is evaluated by pathologists
    measure
    Number of accomplished R0 resection surgery
    time Frame
    Surgery day
  5. description
    Evaluation of quality of life is done using EORTC QLQ C30
    measure
    Evaluation of quality of life
    time Frame
    4 weeks after the end of chemotherapy treatment
  6. description
    Evaluation of quality of life is done using EORTC QLQ-PAN26
    measure
    Evaluation of quality of life
    time Frame
    4 weeks after the end of chemotherapy treatment
Full 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).
Source references
references
  1. citation
    Schwarz L, Bachet JB, Meurisse A, Bouche O, Assenat E, Piessen G, Hammel P, Regenet N, Taieb J, Turrini O, Paye F, Turpin A, Souche FR, Laurent C, Kianmanesh R, Michel P, Vernerey D, Mabrut JY, Turco C, Truant S, Sa Cunha A; PANACHE01-FRENCH08-PRODIGE48 Investigators. Neoadjuvant FOLF(IRIN)OX Chemotherapy for Resectable Pancreatic Adenocarcinoma: A Multicenter Randomized Noncomparative Phase II Trial (PANACHE01 FRENCH08 PRODIGE48 study). J Clin Oncol. 2025 Jun 10;43(17):1984-1996. doi: 10.1200/JCO-24-01378. Epub 2025 Apr 4.
    pmid
    40184561
    type
    DERIVED
  2. 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.
    pmid
    30041614
    type
    DERIVED
Source notices and limitations
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      1. context
        Updated: February 12, 2025
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        display
        February 12, 2025

    Preserved source evidence · Not medical advice