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

Phase 2

Recruiting

• Conditions: nresectable pancreatic cancer patients with germline BRCA pathogenic variant

• Registration Number: JPRN-jRCT1061230031
• Lead Sponsor: Ioka Tatsuya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 33

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified