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Clinical Trials/EUCTR2009-014476-21-DE
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.

Registry
who.int
Start Date
December 20, 2012
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Dekan of the Medical Faculty of the University Erlangen-Nuremberg; Prof. Dr. med. Markus F. Neurath

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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