Status:
COMPLETED
Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This randomized trial examines the effectiveness of chemoradiotherapy compared to chemotherapy alone after induction chemotherapy with 3 cycles of gemcitabine or 6 cycles of FOLFIRINOX in patients wit...
Eligibility Criteria
Inclusion
- 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
Exclusion
- fertile patients who refuse effective contraception during study treatment
- synchron second malignant neoplasm except basal cell carcinoma of the skin and carcinoma in 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 (after Stent implantation in case of obstructive jaundice); 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)
- preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy, myocardial infarction within the past 6 months, unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) class III or IV heart disease
- neurological and/or psychiatric diseases: stroke, dementia, epilepsy, psychosis
- active intractable or uncontrollable infection, HIV-infection
- prior radiotherapy or chemotherapy
Key Trial Info
Start Date :
April 4 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 8 2023
Estimated Enrollment :
830 Patients enrolled
Trial Details
Trial ID
NCT01827553
Start Date
April 4 2013
End Date
November 8 2023
Last Update
April 11 2024
Active Locations (23)
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1
Bayreuth, Klinikum
Bayreuth, Germany, 95445
2
Bochum, Augusta-Kranken-Anstalt, Hämatologie/Onkologie
Bochum, Germany, 44791
3
Bochum, St. Josef-Hospital
Bochum, Germany, 44791
4
Köln Universitätsklinikum
Cologne, Germany, 50937