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PANORAMIX : Optimizing 1st-line NALIRIFOX and Exploring Microbiota's Role in 2nd Line Pancreatic Cancer Treatment

ConditionPDAC - Pancreatic Ductal Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGERCOR - Multidisciplinary Oncology Cooperative Group

About this trial

The main objective of PANORAMIX phase II trial is to optimize first-lie (L1) NALIRIFOX treatment for pancreatic cancer through the implementation of 5-fluorouracil (5-FU) maintenance therapy. Additionally, it aims to investigate the role of antibiotics and microbiota in second-line (L2) treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations (only after interim analysis at Step 2 for patients who were not randomized in first randomization [R1]),

Age ≥18 years old. STEP 1: The patient over 75 years of age is eligible only if the patient's G8 score (G8 questionnaire) is > 14,

Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1,

Histologically or cytologically proven PDAC,

Disqualifiers

Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study,

History of allogenic organ transplantation or active autoimmune, connective tissue disorder, or inflammatory disease requiring systemic treatment,

Diagnosis of any second malignancy that required any treatment within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri,

History of idiopathic pulmonary fibrosis, interstitial lung disease (ILD), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening (TAP-CT-scan),

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nal-IRI

    Drug

    NAL-IRI 50 mg/m2, administered over 80-100 minutes, on day 1 of a 14-days cycle

  • Ciprofloxacin

    Drug

    6 capsules/cycle : 500 mg twice daily on days 1, 8, 15 (on day of gemcitabine infusion) for a maximum of 6 months

  • Paclitaxel

    Drug

    80 mg/m2 weekly on days 1, 8, 15 of each 28-days cycle (at the discretion of investigator)

  • Gemcitabine

    Drug

    1,000 mg/m2 intravenously (IV) over 30 minutes weekly on days 1, 8, 15 of each 28-days cycle

  • Oxaliplatin

    Drug

    60 mg/m2 (starting 2 hours later, administered over 110-130 minutes) on day 1

  • Leucovorin

    Drug

    As part of NALIRIFOX -for 8 cycle treatment: (L + D racemic form) 400 mg/m2 on day 1 (equivalent to 200 mg/m2 levoleucovorin) (starting 30 minutes after oxaliplatin, administered over 25-35 minutes) As part of LV5FU2 maintenance treatment: 400 mg/m2 IV infusion over 30 min on day 1 (equivalent to 200 mg/m2 levoleucovorin). LV could be administered over 2 hours to oxaliplatin according to The National Thesaurus of Digestive Oncology (TNCD) https://www.snfge.org/sites/www.snfge.org/files/tncd/2024-05/tncd\_chap-09-cancer-pancre%CC%81as\_2024-05-17\_1.pdf, at investigator's discretion

  • 5-Fluorouracil

    Drug

    As part of NALIRIFOX -for 8 cycle treatment: 2400 mg/m² IV initiated on day 1, with continuous infusion over 46 hours (no bolus infusion with 5-FU) As part of LV5FU2 maintenance treatment: 400 mg/m2 bolus over 10 min then 2,400 mg/m2 IV infusion over 46h

  • Placebo

    Other intervention

    6 capsules/cycle : 500 mg twice daily (morning and evening; 12 hours should elapse between two doses) on days 1, 8, 15 (on day of gemcitabine infusion) for a maximum of 6 months

Treatment groups

206 Participants
are divided into 4 treatment groups
Group A: STEP 1 - Experimental Arm 1A : First-line NALIRIFOX with LV5FU2 [5-FU/leucovorin] maintenance)Experimental treatment 4 interventions
Group B: STEP 1 - Arm 1B: NALIRIFOXActive comparator 4 interventions
Group C: STEP 2 - Arm 2A: Gemcitabine +/- paclitaxel + ciprofloxacinExperimental treatment 3 interventions
Group D: STEP 2 - Arm 2B: Gemcitabine +/- paclitaxel + placeboActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

6-month progression-free survival (PFS) rate post randomization Step 1 (R1) in Arm 1A

To assess the efficacy of a 6-month PFS rate post R1 in patients with metastatic PDAC who received first-line (L1) NALIRIFOX with LV5FU2 (5-FU/leucovorin) maintenance strategy during Step 1 (Arm 1A).

Time frame
6 months

Secondary outcomes

1

Progression-free survival first-line (PFS-L1) post randomization Step 1 (R1) in Arm 1A and in Arm 1B

To assess PFS-L1 post R1 in Arm 1A and Arm 1B

Time frame
up to 5 years
2

Progression-free survival (PFS) post NALIRIFOX reintroduction (PFS-reintro) in Arm 1A

To assess PFS-reintro in Arm 1A

Time frame
up to 5 years
3

Overall survival post randomization Step 1 (OS-R1) in Arm 1A and in Arm 1B

To assess OS-R1 in Arm 1A and Arm 1B

Time frame
up to 5 years
4

Overall response rate of first-line (ORR-L1) at 4 months in Arm 1A and in Arm 1B

To assess ORR-L1 at 4 months in Arm 1A and Arm 1B, according to RECIST 1.1

Time frame
4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GERCOR - Multidisciplinary Oncology Cooperative Group

Lead sponsor

Servier

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: