Phase II study of FOLFOX for unresectable pancreatic cancer patients with germline BRCA pathogenic variant

JRCT ID: jRCT1061230031

Registered date:29/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Unresectable pancreatic cancer patients with germline BRCA pathogenic variant
• Date of first enrollment: 31/05/2023
• Target sample size: 33
• Study type: Interventional
• Intervention(s): Chemotherapy with oxaliplatin (85mg/m2, day1), levofolinate (200mg/m2, day1), 5-FU (bolus) (400mg/m2, day1), and 5-FU (46hr) (2400mg/m2, day1-3) repeated every 2 weeks.

Outcome(s)

• Primary Outcome: 16 week progression-free survival
• Secondary Outcome: Progression-free survival, overall survival, response rate, disease control rate, adverse events, percentage of introduction of olaparib or other PARP inhibitors, response rate of olaparib, disease control rate of olaparib, progression-free survival of olaparib, overall survival of olaparib, adverse events of oraparib

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Pathologically confirmed pancreatic cancer.
2) Patients with (presumed) germline pathogenic variant of BRCA1 or BRCA2
3) Unresectable or recurrent cancer
4) Age is 18 years or older
5) ECOG performance status of 0 or 1.
6) Patients determined by their physician to be ineligible for FOLFIRINOX therapy.
7) No previous chemotherapy using platinum agents for pancreatic cancer.
8) No previous chemotherapy using PARP inhibitor.
9) Adequate organ functions.
10) Written informed consent.

Exclude criteria

1) Synchronous or metachronous malignancies.
2) Central nerve system metastasis.
3) Pleural effision or ascites requiring puncture or drainage.
4) Grade 2 or higher peripheral sensory or motor neurophathy.
5) Received blood transfusions, blood products, or G-CSF within 2 weeks.
6) Chronic treatment with corticosteroids or other immunosuppressive agents.
7) Interstitial pneumonia, pulmonary fibrosis.
8) Serious co-existing illness.
9) Active infection except for viral hepatitis.
10) Pregnant or lactating women, or women of childbearing potential.
11) Psychiatric disease.

Related Information

• Primary Sponsor: Ioka Tatsuya
• Source(s) of Monetary Support: Yamaguchi University Hospital,Kagawa University Hospital,Japan Oncology Network in Hepatobiliary and Pancreas