Therapeutic effect of intratumoral injection of gemcitabin in patients with advanced pancreatic cancer

Phase 1

• Conditions: Malignant neoplasm of pancreas.; Pancreas, unspecified

• Registration Number: IRCT201201078635N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

advanced pancreatic cancer that is non-operative and is proven by three phasic CT scan and Endosonography and proving positive cytology for pancreatic Adenocarcinoma. Exclusion criteria: first operative pancreatic cancer; second asprin usage; administration of other NSAIDs or anticoagolant in the last week of endosonography or FNA is also important.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Regression of disease. Timepoint: 1) prior to injection of intratumoral Gemcitabin 2) 2 weeks after the first injection 3) 12 weeks after the second injection (ie 24 weeks after first injection). Method of measurement: CT scan and endosonography.;Time to disease progression. Timepoint: 1) prior to injection of intratumoral Gemcitabin 2) 2 weeks after the first injection 3) 12 weeks after the second injection (ie 24 weeks after first injection). Method of measurement: CT scan and endosonography.;Side effects. Timepoint: 1) The first day after injection 2) the second week after the first injection 3) 12 weeks after the first injection (day of the second injection) 4) 48 weeks after first injection. Method of measurement: History and physical examination and lab data as needed and Based on a questionnaire that was attached to the proposal.

Secondary Outcome Measures

Name	Time	Method
Quality of Life. Timepoint: 1) baseline (before first injection) 2) 4 weeks after the second injection. Method of measurement: Scoring based on the SF 36 questionnaire.;Survival. Timepoint: 6 and 12 months after the second injection. Method of measurement: Patients alive long after entering the study, based on history and physical examination.