Induction FOLFIRINOX Followed by Chemoradiation in Locally Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— FOLRT  

Official title:

Induction FOLFIRINOX Followed by Chemoradiation in Locally Advanced Pancreatic Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05399394
• Other study ID #: 2016-000696-25
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 1, 2016
• Est. completion date: June 1, 2022

Study information

• Verified date: May 2022
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: June 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Chemotherapy
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 fluorouracil (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, concurrent chemotherapy consisted of weekly gemcitabine at the dose of 600 mg/mq.

Radiation:
• Radiation
Radiotherapy target volumes are established by CT scan and PET-CT scan. Radiotherapy is delivered with a total dose of 54-59 Gy with fractionation of 1.8 Gy daily for 5 days a week. The Planning Target Volume (PTV) is defined by the Clinical Target Volume (CTV) with a safety margin to include organ motion and set-up errors. Organs at risk for radiation-induced side effects are contoured on the dose planning CT and dose volume histograms (DVH) are calculated. All treatments are delivered with a multifield isocentric technique using a multileaf collimator. A quality-control protocol are applied through cone-beam computed tomography systems (CBCT) for all patients to evaluate the precision of the set-up.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	During treatment, patients are evaluated through a directed history, weekly physical examination and blood exams. The occurrence and nature of any adverse events are recorded in accordance with the National Cancer Institute Common Toxicity Criteria (version 4.02) scale. When multiple treatment-related adverse events of the same type occurred in the same patient, only the most severe ones are reported. Subsequently, the dose of chemotherapy is adjusted according to the number of occurrences of grade 2 or greater events.	four months
Secondary	Overall Survival	Overall Survival (OS) is determined from the day of the histological diagnosis. OS curves are calculated with the Kaplan-Meier method.	3 years
Secondary	Progression-free survival	Progression-free survival (PFS) is obtained from the beginning of treatment to the observation of progression/recurrence, or to last follow-up if no event is observed. PFS curves are calculated with the Kaplan-Meier method.	3 years
Secondary	Metastases-free survival	Metastases-free survival (MFS) is obtained from the beginning of treatment to the observation of distant progression, or to last follow-up if no event is observed. MFS curves are calculated with the Kaplan-Meier method.	3 years
Secondary	Incidence of Local-regional Tumor Control	Patients are not considered to have local-regional control unless they achieve at least a partial response of their primary tumor or stable disease by imaging. Patients who do not achieve objective response are considered to have local-regional failure. Local-regional control rates are analyzed using the Kaplan-Meier method.	3 years