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 17 January 2021
ct scan
carcinoma
metastasis
oxaliplatin
chemoradiotherapy
pancreatic adenocarcinoma
gemcitabine
irinotecan
cancer chemotherapy
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 on17 January 2021

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