NCT02707315

A Study of Pre-Operative Cyberknife in Patients With Potentially Resectable Pancreas Cancer

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: The Cooper Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is evaluating stereotactic radiosurgery (CyberKnife) plus chemotherapy for the treatment of potentially resectable adenocarcinoma of the pancreas

Detailed description

This study is evaluating the role of neoadjuvant chemotherapy and CyberKnife therapy in increasing the number of patients who are able to successfully undergo definitive surgical management of their pancreatic carcinoma. In addition, we will evaluate the associated therapeutic toxicities and gather data regarding the quality of life indicators at similar time intervals for an improved overall assessment of the effects of this course of treatment on our patients. Surgery is deemed the only curative technique for pancreatic cancer. Unfortunately, more than 80% of patients who present with the disease cannot be cured by resection. The literature reports median survival for resectable patients on the order of 19 months, with a 20% 5 year survival rate. For patients unable to undergo surgical resection, the median survival in the literature is approximately 11 months. In the absence of the proposed protocol, this patient population would be treated as per the standard of care for locally advanced non-metastatic surgically unresectable pancreatic malignancies, which would include a combination of chemotherapy and radiation therapy. The anticipated Grade 4 and above toxicity would be approximately 3-5% from this regimen. The rate of G 4 and above toxicity is not known with the use of this neoadjuvant regimen, and, therefore, this constitutes the major risk associated with this protocol therapy. The associated benefit, however, is the anticipated improvement in median survival that these patients may derive from the ability to successfully undergo surgical resection. A secondary proposed benefit is the potential for reduction in the treatment associated toxicity with this altered multimodality schedule when compared to traditional multimodality care or non-surgical care of locally advanced pancreatic malignancy.

Conditions

• Pancreas Cancer
• Pancreatic Cancer
• Adenocarcinoma of the Pancreas
• Pancreas Adenocarcinoma
• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine
RADIATION	Stereotactic Radiosurgery

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-12-01
• First posted: 2016-03-14
• Last updated: 2016-03-14

Locations

1 site across 1 country: United States