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Open Access Study protocol

Clinical phase I/II trial to investigate neoadjuvant intensity-modulated short term radiation therapy (5 × 5 gy) and intraoperative radiation therapy (15 gy) in patients with primarily resectable pancreatic cancer - NEOPANC

Falk Roeder12*, Carmen Timke12, Ladan Saleh-Ebrahimi12, Lutz Schneider3, Thilo Hackert3, Werner Hartwig3, Annette Kopp-Schneider4, Frank W Hensley2, Markus W Buechler3, Juergen Debus12, Peter E Huber12 and Jens Werner3

Author Affiliations

1 Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany

2 Department of Radiation Oncology, University of Heidelberg, Heidelberg, Germany

3 Department of Surgery, University of Heidelberg, Heidelberg, Germany

4 Department of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg, Germany

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BMC Cancer 2012, 12:112  doi:10.1186/1471-2407-12-112

Published: 23 March 2012

Abstract

Background

The current standard treatment, at least in Europe, for patients with primarily resectable tumors, consists of surgery followed by adjuvant chemotherapy. But even in this prognostic favourable group, long term survival is disappointing because of high local and distant failure rates. Postoperative chemoradiation has shown improved local control and overalls survival compared to surgery alone but the value of additional radiation has been questioned in case of adjuvant chemotherapy. However, there remains a strong rationale for the addition of radiation therapy considering the high rates of microscopically incomplete resections after surgery. As postoperative administration of radiation therapy has some general disadvantages, neoadjuvant and intraoperative approaches theoretically offer benefits in terms of dose escalation, reduction of toxicity and patients comfort especially if hypofractionated regimens with highly conformal techniques like intensity-modulated radiation therapy are considered.

Methods/Design

The NEOPANC trial is a prospective, one armed, single center phase I/II study investigating a combination of neoadjuvant short course intensity-modulated radiation therapy (5 × 5 Gy) in combination with surgery and intraoperative radiation therapy (15 Gy), followed by adjuvant chemotherapy according to the german treatment guidelines, in patients with primarily resectable pancreatic cancer. The aim of accrual is 46 patients.

Discussion

The primary objectives of the NEOPANC trial are to evaluate the general feasibility of this approach and the local recurrence rate after one year. Secondary endpoints are progression-free survival, overall survival, acute and late toxicity, postoperative morbidity and mortality and quality of life.

Trial registration

NCT01372735.