Phase II study of hypofractionated radio-chemotherapy with gemcitabine plus oxaliplatin for unresectable nonmetastatic locally advanced pancreatic cancer. - IRST 157.01

• Conditions: Resectable patients with locally advanced pancreatic disease treated with an innovative radio-chemotherapy scheme; MedDRA version: 9.1Level: HLGTClassification code 10015674

• Registration Number: EUCTR2010-020379-22-IT
• Lead Sponsor: ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 < 1.5 X institutional upper limit of normal - AST (SGOT)/ALT (SGPT) <2.5 X institutional upper limit of normal (= 5 in patients with liver metastases) - Creatinine < 1.5 X institutional upper limit of normal • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. • Ability to understand and the willingness to sign a written informed consent document.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified