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.

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Key information

Conditions

Locally Advanced Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Gemcitabine

Drug

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

125I brachytherapy PLUS gemcitabine

Other

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 outcomes

Survival

Time frame: 2 years after the inclusion of the last patient

Secondary outcomes

response rate, clinical benefit response, and safety

Time frame: 2 month after the treatment finished

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy Versus Gemcitabine Alone in Patients With Locally Advanced Pancreatic Cancer

Important dates

Study start: 2003
Primary completion: 2007
Study completion: 2008
First posted: Mar 27, 2008
Registry last updated: Mar 27, 2008

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.

Published trials that share one or more normalized conditions with this study.

Completed