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Significance of Chemoradiation Following Induction Chemotherapy in Locally Advanced,Unresectable Pancreatic Cancer -a Randomised Phase 3 Trial: Chemoradiation Following Induction Chemotherapy Compared With Chemotherapy Alone


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

Significance of Chemoradiation Following Induction Chemotherapy in Locally Advanced,Unresectable Pancreatic Cancer -a Randomised Phase 3 Trial: Chemoradiation Following Induction Chemotherapy Compared With Chemotherapy Alone


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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Participants will be followed for the duration of therapy and for 5 years after the last study treatment

Safety Issue:

No

Principal Investigator

Rainer Fietkau, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Strahlenklinik, Universitätsklinikum Erlangen

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

2009-014476-21

NCT ID:

NCT01827553

Start Date:

March 2013

Completion Date:

April 2022

Related Keywords:

  • Pancreatic Cancer
  • pancreatic cancer
  • chemoradiotherapy
  • chemotherapy
  • FOLFIRINOX
  • gemcitabine
  • Pancreatic Neoplasms

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