Induction FOLFIRINOX Followed by Chemoradiation in Locally Advanced Pancreatic Cancer

NCT05399394 | Unknown Phase 2

• 1 other identifier: 2016-000696-25
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pancreatic Cancer

Keywords

chemoradiation; FOLFIRINOX

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall Survival

  3 years

• Progression-free survival

  3 years

• Metastases-free survival

  3 years

• Incidence of Local-regional Tumor Control

  3 years

Study Arms (1)

LAPC patients

EXPERIMENTAL

Patients treated with induction FOLFIRINOX; for patients without disease progression as detected through restaging exams, chemotherapy was followed by chemoradiation which consisted of conformal radiation therapy and concurrent gemcitabine at the dose of 600 mg/mq weekly.

Drug: Chemotherapy; Radiation: Radiation

Interventions

Chemotherapy DRUG

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.

Also known as: Induction therapy

LAPC patients

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.

LAPC patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• proven cytological or histological diagnosis of pancreatic ductal adenocarcinoma;
• borderline resectable or unresectable pancreatic tumours;
• no previous radiochemotherapy to abdomen;
• I Eastern Cooperative Oncology Group (ECOG) performance status;
• adequate cardiac, liver and kidney function and a good bone marrow reserve.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Campus Bio-Medico University: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Drug Therapy; Neoadjuvant Therapy; Radiation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Combined Modality Therapy; Physical Phenomena

Study Officials

• Michele Fiore, MD

  Campus Bio-Medico University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: June 1, 2022
• Study Start: July 1, 2016
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share