Randomized phase II – study evaluating EGFR targeting therapy with Cetuximab in combination with radiotherapy and chemotherapy for patients with locally advanced pancreatic cancer – PARC: study protocol ISRCTN56652283Report as inadecuate




Randomized phase II – study evaluating EGFR targeting therapy with Cetuximab in combination with radiotherapy and chemotherapy for patients with locally advanced pancreatic cancer – PARC: study protocol ISRCTN56652283 - Download this document for free, or read online. Document in PDF available to download.

BMC Cancer

, 5:131

First Online: 11 October 2005Received: 29 July 2005Accepted: 11 October 2005DOI: 10.1186-1471-2407-5-131

Cite this article as: Krempien, R., Muenter, M., Huber, P. et al. BMC Cancer 2005 5: 131. doi:10.1186-1471-2407-5-131

Abstract

BackgroundPancreatic cancer is the fourth commonest cause of death from cancer in men and women. Advantages in surgical techniques, radiation therapy techniques, chemotherapeutic regimes, and different combined-modality approaches have yielded only a modest impact on the prognosis of patients with pancreatic cancer. Thus there is clearly a need for additional strategies. One approach involves using the identification of a number of molecular targets that may be responsible for the resistance of cancer cells to radiation or to other cytotoxic agents. As such, these molecular determinants may serve as targets for augmentation of the radiotherapy or chemotherapy response. Of these, the epidermal growth factor receptor EGFR has been a molecular target of considerable interest and investigation, and there has been a tremendous surge of interest in pursuing targeted therapy of cancers via inhibition of the EGFR.

Methods-designThe PARC study is designed as an open, controlled, prospective, randomized phase II trial. Patients in study arm A will be treated with chemoradiation using intensity modulated radiation therapy IMRT combined with gemcitabine and simultaneous cetuximab infusions. After chemoradiation the patients receive gemcitabine infusions weekly over 4 weeks. Patients in study arm B will be treated with chemoradiation using intensity modulated radiation therapy IMRT combined with gemcitabine and simultaneous cetuximab infusions. After chemoradiation the patients receive gemcitabine weekly over 4 weeks and cetuximab infusions over 12 weeks. A total of 66 patients with locally advanced adenocarcinoma of the pancreas will be enrolled. An interim analysis for patient safety reasons will be done one year after start of recruitment. Evaluation of the primary endpoint will be performed two years after the last patient-s enrolment.

DiscussionThe primary objective of this study is to evaluate the feasibility and the toxicity profile of trimodal therapy in pancreatic adenocarcinoma with chemoradiation therapy with gemcitabine and intensity modulated radiation therapy IMRT and EGFR-targeted therapy using cetuximab and to compare between two different methods of cetuximab treatment schedules concomitant versus concomitant and sequential cetuximab treatment.

Secondary objectives are to determine the role and the mechanism of cetuximab in patient-s chemoradiation regimen, the response rate, the potential of this combined modality treatment to concert locally advanced lesions to potentially resectable lesions, the time to progression interval and the quality of life.

AbbreviationsCROClinical Research Organisation

CRFCase Report Form

CTCCommon Toxicity Criteria

CTVClinical Target Volume

dkfzGerman Cancer Research Center

EBRTExternal Beam Radiation Therapy

EGFREpidermal Growth Factor Receptor

GCPGood Clinical Practice

GTVGross Target Volume

IMRTIntensity Modulated Radiation Therapy

IORTIntra-Operative Radiation Therapy

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2407-5-131 contains supplementary material, which is available to authorized users.

R Krempien, MW Muenter contributed equally to this work.

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