NCT01372735

Trial of Neoadjuvant Short Course IMRT Followed by Surgery and IORT for Resectable Pancreatic Cancer

Clinical Phase I/II Trial to Investigate Neoadjuvant Intensity-Modulated Short Term Radiation Therapy (5x5 Gy) and Intraoperative Radiation Therapy (15 Gy) in Patients With Primarily Resectable Pancreatic Cancer - NEOPANC

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: University Hospital Heidelberg · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The current standard treatment for patients with primarily resectable pancreatic 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 overall 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. Therefore the NEOPANC trial has been designed as a prospective, one armed single center study to investigate a combination of neoadjuvant short course intensity-modulated radiation therapy (5x5 Gy) in combination with surgery and intraoperative radiation therapy (15 Gy) followed by adjuvant chemotherapy according to german treatment guidelines in patients with primarily resectable pancreatic cancer. 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.

Conditions

• Pancreatic Neoplasms

Interventions

Type	Name	Description
RADIATION	neoadjuvant short course IMRT	neoadjuvant short course intensity-modulated radiotherapy, single dose 5 Gy, total dose 25 Gy (5x5 schedule) to primary tumor and regional lymph nodes
RADIATION	IORT	intraoperative radiation therapy during resection, 15 Gy (to 90% isodose) to tumor bed

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-08-01
• Completion: 2017-08-01
• First posted: 2011-06-14
• Last updated: 2011-06-14

Locations

3 sites across 1 country: Germany