Study of Induction Chemotherapy Followed by Radiochemotherapy in Locally Advanced Pancreatic Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
Pancreatic Cancer
Interventions
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 CTV with a safety margin of 1cm in all directions 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 15-MV linear accelerator (Varian Medical System) with a multifield isocentric technique using a multileaf collimator. A quality-control protocol are applied for all patients with periodical digital portal images to evaluate the precision of the set-up.

DRUG

Chemotherapy

The induction phase of the treatment plan is designed to administer gemcitabine 1000 mg/mq and oxaliplatin 100 mg/mq every 14 days for four doses. Chemotherapy concurrent to conformal radiation therapy is gemcitabine at the dose of 600 mg/mq weekly.

All Listed Sponsors
lead

Campus Bio-Medico University

OTHER

NCT02984501 - Study of Induction Chemotherapy Followed by Radiochemotherapy in Locally Advanced Pancreatic Cancer | Biotech Hunter | Biotech Hunter