EUS-guided Intratumoral Gemcitabine in Locally Advanced Unresectable Pancreatic Cancer

Pancreatic Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01834170
• Other study ID #: DDRC 92-1
• Status: Completed
• Phase: Phase 1
• First received: April 6, 2013
• Last updated: December 1, 2014
• Start date: April 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University of Tehran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with histologically verified pancreatic adenocarcinoma who have locally advanced unresectable tumor

Exclusion Criteria:

• Early stage resectable pancreatic cancer with the intact surrounding major vessels on imaging

• Pancreatic cancer with distant metastasis

• Unwilling to sign informed consent

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Digestive Disease Research Center, Shariati ospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
University of Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events as a measure of safety and tolerability		6 months	Yes
Secondary	Proportion of participants who remain alive one year after enrollment compared to the historical matched control group		1 year	No