Resectable patients with locally advanced pancreatic disease treated with an innovative radio-chemotherapy scheme MedDRA version: 9.1 Level: HLGT Classification code 10015674
Conditions
Interventions
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Gemcitabine
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 1000-
Pharmaceutical For
Sponsors
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with histologically or cytologically confirmed diagnosis of pancreatic cancer are candidates for the trial. • Stage III disease (AJCC TNM 6th edition, 2002). Inoperable disease, by radiological and surgical evaluation; • Age >18 years and =75 years. • Life expectancy of greater than 12 weeks. • ECOG performance status 0-2 (see Appendix A). • Presence of at least of one measurable lesion in agreement to RECIST criteria • Patients must have normal organ and marrow function as defined below: - Leukocytes >3,000/?L - Absolute neutrophil count >1,500/?L - Platelets >100,000/?L - Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients who have had any chemotherapy or radiotherapy prior to entering the study; • Stage IV disease; • Participation in another clinical trial with any investigational agents within 30 days prior to study screening. • Previous malignancy except cervical carcinoma in situ, adequately treated basal cell carcinoma, superficial bladder tumors, or other malignancies curatively treated >5 years before study entry. • History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and oxaliplatin or other agents used in the study. • Active brain or leptomeningeal disease • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Step A: The primary objective is to evaluate the safety of the treatment. Step B: The primary objective is to evaluate the proportion of the resectable patients after radio-chemotherapy.;Secondary Objective: Step A: Secondary objective is the control of IM (internal margin) intra-fraction. Step B: Secondary objectives are: overall survival (OS), local progression free survival (LPFS) and progression free survival (PFS).;Primary end point(s): Step A: The primary objective is to evaluate the safety of the treatment. Secondary objective is the control of IM (internal margin) intra-fraction. Step B: The primary objective is to evaluate the proportion of the resectable patients after radio-chemotherapy. Secondary objectives are: overall survival (OS), local progression free survival (LPFS) and progression free survival (PFS). | — |
Countries
Italy
Outcome results
None listed