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Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy

Primary Purpose

Locally Advanced Pancreatic Cancer

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

gemcitabine

125I brachytherapy PLUS gemcitabine

About this trial

This is an interventional treatment trial for Locally Advanced Pancreatic Cancer focused on measuring pancreatic cancer, locally advanced

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

response rate, clinical benefit response, and safety

Full Information

NCT ID

NCT00644618

First Posted

March 24, 2008

Last Updated

March 24, 2008

Sponsor

Huazhong University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT00644618

Brief Title

Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Huazhong University of Science and Technology

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Pancreatic Cancer

Keywords

pancreatic cancer, locally advanced

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

gemcitabine

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

125I brachytherapy PLUS gemcitabine

Intervention Description

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 Measure Information:

Title

Survival

Time Frame

2 years after the inclusion of the last patient

Secondary Outcome Measure Information:

Title

response rate, clinical benefit response, and safety

Time Frame

2 month after the treatment finished

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Learn more about this trial

Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy

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