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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01834170
Other study ID # DDRC 92-1
Secondary ID
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


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
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