Clareo Health | Phase II Study of Hypofractionated Radio-chemotherapy With Gemcitabine Plus Oxaliplatin for Unresectable Nonmetastatic Locally Advanced Pancreatic Cancer.
Phase II Study of Hypofractionated Radio-chemotherapy With Gemcitabine Plus Oxaliplatin for Unresectable Nonmetastatic Locally Advanced Pancreatic Cancer.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Patients with histologically or cytologically confirmed diagnosis of pancreatic cancer are candidates for the trial.
2. Stage III disease (AJCC TNM 6th edition, 2002). Inoperable disease, by radiological and surgical evaluation;
3. Age \>18 years and ≤75 years.
4. Life expectancy of greater than 12 weeks.
5. ECOG performance status 0-2 (see Appendix A).
6. Presence of at least of one measurable lesion in agreement to RECIST criteria
7. Patients must have normal organ and marrow function as defined below:
* Leukocytes \>3,000/uL
* Absolute neutrophil count \>1,500/uL
* Platelets \>100,000/uL
* Total bilirubin \< 1.5 X ULN
* AST (SGOT)/ALT (SGPT) \<2.5 X ULN
* Creatinine \< 1.5 X ULN
8. 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.
9. Ability to understand and the willingness to sign a written informed consent document.
You may not be if
1. Patients who have had any chemotherapy or radiotherapy prior to entering the study;
2. Stage IV disease;
3. Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
4. 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.
5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and oxaliplatin or other agents used in the study.
6. Active brain or leptomeningeal disease
7. 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.
