Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Soroka University Medical Center
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Age \> 18 years.
2. Newly-diagnosed, histologically/cytologically or CA 19.9 confirmed ULAPC
3. KPS \> 60
4. No previous RT to abdomen
5. No serious comorbid condition Version 1, December 1, 2010
6. No treatment with biological response modifiers or cytotoxic agents within four weeks prior to study entry, apart from induction chemotherapy with gemcitabine
7. No participation in clinical trial using any investigational drug or device within four weeks prior to study entry
8. No serious complication of malignant condition
9. No previous or concurrent malignancy at other sites except cone biopsied in situ carcinoma of the uterine cervix and adequately treated basal cell or squamous cell carcinoma of the skin
10. Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:
* Hemoglobin \> 9.0 Gm/dL
* WBC count \> 4.0x109/L
* Neutrophile count \> 1.5 cells x 109/L,
* Platelet count \> 100 x 109/L,
* Creatinine \< 1.5 mg/dL
* Total bilirubin \< upper limit of normal (ULN)
* AST/SGOT \< ULN
* Calcium \< ULN
11. Ability to sign informed consent
12. Ability to attend follow-up visits
You may not be if
1. Operable disease
2. Distant metastases
3. KPS \< 60
4. Previous RT to abdomen
5. Treatment with biological response modifiers or cytotoxic agents other then induction gemcitabine within four weeks prior to study entry
6. Participation in clinical trial using any investigational drug or device within four weeks prior to study entry
7. Major surgical procedure within two weeks prior to study entry
8. Serious comorbid condition, inclusive but not limited to myocardial infarction within previous six months, uncontrolled cardiac arrhythmias, uncontrolled angina pectoris, active infection including acute hepatitis
9. Serious complication of malignant condition
10. Previous or concurrent malignancy
11. Inadequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:
* Hemoglobin \< 9.0 Gm/dL
* WBC count \< 4.0x109/L
* Neutrophile count \< 1.5 cells x 109/L,
* Platelet count \< 100 x 109/L,
* Creatinine \> 1.5 mg/dL
* Total bilirubin \> ULN (upper limit of normal)
* AST/SGOT \> ULN
* Calcium \> ULN
12. Inability to sign informed consent
13. Psychological, familial, sociological or geographical conditions which do permit regular medical follow-up and compliance with the protocol.
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