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NCT Number: NCT01834170

EUS-guided Intratumoral Gemcitabine in Locally Advanced Unresectable Pancreatic Cancer

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.

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Key information

Conditions

Pancreatic Adenocarcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Digestive Disease Research Center, Shariati ospital

Tehran, Iran

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemcitabine

Drug

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

Other names: Gemzar

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. Proportion of participants who remain alive one year after enrollment compared to the historical matched control group

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Tehran

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 17, 2013
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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