Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy

  • STATUS
    Recruiting
  • End date
    Apr 15, 2022
  • participants needed
    830
  • sponsor
    University of Erlangen-Nürnberg Medical School
Updated on 15 October 2020
Investigator
Oliver Ott, MD
Primary Contact
Erlangen Universit tsklinikum (8.7 mi away) Contact
+89 other location
ct scan
carcinoma
metastasis
chemoradiotherapy
pancreatic adenocarcinoma
gemcitabine
adenocarcinoma
antineoplastic
metastatic pancreatic cancer
folfirinox
resectable pancreatic cancer

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 with locally advanced, non resectable and non-metastatic pancreatic cancer. Chemotherapeutic agent in chemoradiotherapy is gemcitabine administered in 5 cycles, the agent and its administration for sole chemotherapy is determined by induction chemotherapy. Operability of tumor is evaluated at week 11 after randomisation. Patients will be followed for the duration of therapy and for 5 years after the last study treatment. Overall survival at the end of follow up is defined as primary endpoint. Secondary endpoints are tumor-free survival, rate of local recurrence or local progression, rate of distant metastasis, acute and late toxicity of the chemoradiotherapy, quality of life, rate of remission, rate of curative resections (R0) after chemotherapy and chemoradiotherapy. It is planned to include a total number of 830 patients.

Details
Treatment Induction chemotherapy with gemcitabine or FOLFIRINOX, Radiotherapy, 28 x 1.8 Gy, Chemotherapy, gemcitabine, Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy
Clinical Study IdentifierNCT01827553
SponsorUniversity of Erlangen-Nürnberg Medical School
Last Modified on15 October 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Pancreatic Cancer or Pancreatic Disorders or Islet Ce417ll Cancer or Neoplasm of unspecified nature of digestive system or Pancreatic disorder or Dige...?
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
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