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Induction FOLFIRINOX Followed by Chemoradiation in Locally Advanced Pancreatic Cancer

NCT05399394 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-06-01

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Campus Bio-Medico University

    lead OTHER

Principal Investigators

  • Michele Fiore, MD · Campus Bio-Medico University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2022-04-01
Completion
2022-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05399394 on ClinicalTrials.gov