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

ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI0 sitesSeptember 28, 2010

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 28, 2010

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI

Eligibility 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 \< 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