Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy

NCT00644618 | Completed Phase 3 DMC

• 1 other identifier: Union Hospital
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Locally Advanced Pancreatic Cancer

Keywords

pancreatic cancer; locally advanced

Outcome Measures

Primary Outcomes (1)

• Survival

  2 years after the inclusion of the last patient

Secondary Outcomes (1)

• response rate, clinical benefit response, and safety

  2 month after the treatment finished

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: gemcitabine

B

EXPERIMENTAL

Other: 125I brachytherapy PLUS gemcitabine

Interventions

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

A

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

B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 27, 2008
• Study Start: January 1, 2003
• Primary Completion: December 1, 2007
• Study Completion: January 1, 2008
• Last Updated: March 27, 2008

Record last verified: 2008-03