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


Phase 1
18 Years
80 Years
Open (Enrolling)
Both
Pancreatic Adenocarcinoma

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of participants with adverse events as a measure of safety and tolerability

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Mehdi Mohamadnejad, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Digestive Disease Research Center, University of Tehran/Medical sciences

Authority:

Iran: Ethics Committee

Study ID:

DDRC 92-1

NCT ID:

NCT01834170

Start Date:

April 2013

Completion Date:

April 2014

Related Keywords:

  • Pancreatic Adenocarcinoma
  • Pancreatic cancer
  • Pancreatic adenocarcinoma
  • Endoscopic ultrasound
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms

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