Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00644618

Enrollment

120

Registered

2008-03-27

Start date

2003-01-31

Completion date

2008-01-31

Last updated

2008-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Pancreatic Cancer

Keywords

pancreatic cancer, locally advanced

Brief summary

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.

Interventions

DRUGgemcitabine

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

OTHER125I 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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Survival	2 years after the inclusion of the last patient

Secondary

Measure	Time frame
response rate, clinical benefit response, and safety	2 month after the treatment finished

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026