Randomized Controlled Trial Of Gemcitabine Combined With 125I Brachytherapy

Study Overview

Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy

For patients with unresectable locally advanced pancreatic cancer, the combined use of external-beam radiation therapy (EBRT) and systemic chemotherapy of 5-FU has been widely recognized as the most effective chemoradiotherapy approach.But most patients succumb to local recurrence and metastasis after treatment, and the prognosis remains poor On the basis of the development and superiority of the interstitial brachytherapy and the radiosensitizing effect of gemcitabine, we performed a clinical study to explore the interaction of improved I-125 brachytherapy and gemcitabine and compare the regimen to the standard gemcitabine treatment specifically in patients with non-metastatic, unresectable pancreatic cancer.

N/A

Locally Advanced Pancreatic Cancer

DRUG: gemcitabine
OTHER: 125I brachytherapy PLUS gemcitabine

Union Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2008-03-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2008-03-24
First Submitted that Met QC Criteria 2008-03-24	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2008-03-27
First Posted (ESTIMATED) 2008-03-27	Results First Posted N/A	Last Verified 2008-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Single Group

Masking:
Triple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: A	DRUG: gemcitabine a 30-minute intravenous infusions of gemcitabine 1,000 mg/m2 weekly×7, followed by a 1-week pause, and then weekly×3
EXPERIMENTAL: B	OTHER: 125I brachytherapy PLUS gemcitabine 125I brachytherapy PLUS a 30-minute intravenous infusions of gemcitabine 1,000 mg/m2 weekly×7, followed by a 1-week pause, and then weekly×3

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: A

DRUG: gemcitabine

a 30-minute intravenous infusions of gemcitabine 1,000 mg/m2 weekly×7, followed by a 1-week pause, and then weekly×3

EXPERIMENTAL: B

OTHER: 125I brachytherapy PLUS gemcitabine

125I brachytherapy PLUS a 30-minute intravenous infusions of gemcitabine 1,000 mg/m2 weekly×7, followed by a 1-week pause, and then weekly×3

Primary Outcome Measures	Measure Description	Time Frame
Survival		2 years after the inclusion of the last patient

Secondary Outcome Measures	Measure Description	Time Frame
response rate, clinical benefit response, and safety		2 month after the treatment finished

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically proven
locally advanced pancreatic adenocarcinoma stage
No systemic metastases
Age between 18-75
Karnofsky-Performance Status equal to, or greater than 70 %
At least a 2-dimensionally measurable tumor lesion
Adequate renal and liver function
Written consent statement
Patients' compliance and geographical proximity
Life expectancy equal to or greater than 3 months

Serious psychological disease
Pregnancy and inadequate or not secure contraception or breastfeeding women
Other previous malignant disease in the past two years
Serious systemic concomitant diseases, excluding participation in a trial
Other experimental treatment during or within 6 weeks prior to this trial (including chemotherapeutic medicine or immune-therapies)
Every other condition or therapy assessed by the physician as an eventual risk for the patient or restricting the aims of the trial
Distant metastasis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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General Publications

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Clinical Trial Record