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Brief Title: EUS-guided Intratumoral Gemcitabine in Locally Advanced Unresectable Pancreatic Cancer
Official Title: EUS-guided Intratumoral Gemcitabine Therapy in Locally Advanced Unresectable Pancreatic Cancer: A Phase 1 Study
Study ID: NCT01834170
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Digestive Disease Research Center, Shariati ospital, Tehran, , Iran, Islamic Republic of
Name: Mehdi Mohamadnejad, M.D.
Affiliation: Digestive Disease Research Center, University of Tehran/Medical sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Reza Malekzadeh, M.D.
Affiliation: Digestive Disease Research Center, University of Tehran/Medical Sciences
Role: STUDY_CHAIR