Induction FOLFIRINOX Followed by Chemoradiation in Locally Advanced Pancreatic Cancer

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

There is no a clear consensus regarding the optimal treatment strategy of locally advanced pancreatic cancer. There is a potential role for neoadjuvant therapy to treat micrometastatic disease with chemotherapy, as well as for the treatment of local disease with radiotherapy. The investigators evaluated the safety and efficacy of induction FOLFIRINOX followed by a high weekly dose of gemcitabine concurrent to radiation therapy in patients with borderline resectable and unresectable locally advanced pancreatic cancer (LAPC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Campus Bio-Medico University

Criteria

Inclusion Criteria:

• proven cytological or histological diagnosis of pancreatic ductal adenocarcinoma;

• borderline resectable or unresectable pancreatic tumours;

• no previous radiochemotherapy to abdomen;

• 0-I Eastern Cooperative Oncology Group (ECOG) performance status;

• adequate cardiac, liver and kidney function and a good bone marrow reserve.

Exclusion Criteria:

• resectable and metastatic disease;

• previous or concomitant malignant disease;

• one or more of the following clinical conditions: infection, pregnancy or breast-feeding, liver failure, kidney failure, Pa O2 < 65 mmHg, Pa carbon dioxide (CO2) > 40 mmHg, mental disability.