EUCTR2009-014476-21-DE
Active, not recruiting
Phase 1
Chemoradiation following induction chemotherapy in locally advanced, unresectable pancreatic cancer -a randomised phase 3 trial:Chemoradiation following induction chemotherapy compared with chemotherapy alone.
Dekan of the Medical Faculty of the University Erlangen-Nuremberg; Prof. Dr. med. Markus F. Neurath0 sites830 target enrollmentDecember 20, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dekan of the Medical Faculty of the University Erlangen-Nuremberg; Prof. Dr. med. Markus F. Neurath
- Enrollment
- 830
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years
- •histologically confirmed adenocarcinoma of the pancreas
- •no evidence of distant metastasis based on computed tomography of the thorax and abdomen
- •non resectable pancreatic cancer
- •no evidence of peritoneal carcinosis
- •ECOG\-performance status \= 2
- •Signed study\-specific consent form prior to therapy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •Pregnant or lactating/nursing women
- •Fertile patients who refuse effective contraception during study treatment
- •synchron second malignant neoplsam except basal cell carcinoma of the skin and carcinoma is situ of the cervix after curative therapy
- •The Inclusion of patients with prior or concurrent malignancy (\= 5 years prior to enrolment in study) must be discussed
- •Chronic inflammatory disease of the intestine
- •Known allergic reactions on study medication
- •On\-treatment participation on other trials
- •Insufficient liver function: Bilirubin \> 2,0 mg/dl; SGOT, SGPT, alkaline phosphatase, gGT more than 3 times upper limit of normal and after Stent implantation according to centre\`s practice or after having consulted with PI); cirrhosis of the liver Child B and C
- •Insufficient bone marrow function: WBC \< 3,0 x 10^9/l, Platelets \> 100 x 10^9/l
- •Serum creatinine \> 1,5 mg/dl, creatinin clearance \< 60ml/min (or comparable test)
Outcomes
Primary Outcomes
Not specified
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