NCT01834170

EUS-guided Intratumoral Gemcitabine in Locally Advanced Unresectable Pancreatic Cancer

EUS-guided Intratumoral Gemcitabine Therapy in Locally Advanced Unresectable Pancreatic Cancer: A Phase 1 Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Tehran · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Pancreatic cancer is the 11th most common type of cancer but it is the fourth leading cause of cancer death. The only effective treatment for pancreatic cancer includes surgery. However, only 20% of the patients have surgically treatable disease. Also, the 5-year survival for the surgically treated patients is only 15%. About 40% of the patients present with advanced disease with distant metastasis, and the remaining 40% present with locally advanced unresectable cancer with the tumor invaded into surrounding major vessels. For those with locally advanced disease, systemic chemotherapy with or without radiotherapy provides palliation of the symptoms but cannot cure the disorder. Systemic chemotherapy is given through peripheral vessels. The investigators hypothesized that direct injection of the chemotherapeutic drug into the tumor may help to boost the effect of systemic chemotherapy and radiotherapy in those with locally advanced pancreatic cancer.

Detailed description

In this study, gemcitabine will be injected directly into the tumor by means of endoscopic ultrasound (EUS) in the eligible patients.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	Two intratumoral injections of gemcitabine under endoscopic ultrasound (EUS)-guidance at month 0 and month 3. The patients will receive systemic chemotherapy with or without radiotherapy at the discretion of oncologist

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-04-17
• Last updated: 2014-12-02

Locations

1 site across 1 country: Iran