Clinical trial NCT05399394: Induction FOLFIRINOX Followed by Chemoradiation in Locally Advanced Pancreatic Cancer
Official title: Induction FOLFIRINOX Followed by Chemoradiation in Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: chemoradiation
FOLFIRINOX
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed description: Continued optimization in multimodality therapy and an accurate patient selection remain crucial points for the appropriate treatment of patients with pancreatic cancer. In all patients an accurate pre-treatment staging was performed, including multilayer CT scan, positron emission computed tomography (PET-CT) with 18F-2-fluoro-2-deoxy-D-glucose (FDG) and laparoscopy with peritoneal washing. Patients with the evidence of metastatic disease were excluded, and thus only a small number of patients was consequently enrolled with this approach.The induction phase of the treatment plan was designed to administer FOLFIRINOX protocol (oxaliplatin 85 mg/mq and irinotecan 180 mg/mq plus leucovorin 400 mg/mq followed by bolus FU 400 mg/mq on day 1, then FU 2,400 mg/mq as a 46-hour continuous infusion) every 14 days for four cycles. In the combined phase of the treatment radiotherapy target volumes were established by CT scan and PET-CT scan. Concurrent chemotherapy consisted of gemcitabine at the dose of 600 mg/mq weekly. Four weeks after the completion of radiochemotherapy, restaging including CT scan and PET-CT scan was performed. Tumor response was defined in accordance with the World Health Organization (WHO) definition through CT scan and PET-CT scan. Surgery was considered in patients whose tumors were technically resectable. After resection, patients were evaluated every three months by means of a standard surveillance protocol that included history and physical examination, cross-sectional imaging and measurement of serum markers, and the intervals were extended to six months after two years

Eligibility 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: four months
Secondary outcomes:
measure: Overall Survival
timeFrame: 3 years
measure: Progression-free survival
timeFrame: 3 years
measure: Metastases-free survival
timeFrame: 3 years
measure: Incidence of Local-regional Tumor Control
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Campus Bio-Medico University
name: Michele Fiore, MD
role: PRINCIPAL_INVESTIGATOR
References: