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NCT00214136 Clinical Trial

Intensity Modulated Radiation Therapy (IMRT) Radiotherapy for Treating Prostate Pelvic Nodes

Prostate Cancer Clinical Trial

Official title:
A Phase II Prostate Cancer Trial Treating Pelvic Lymph Nodes to High Dose Using Intensity Modulated Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00214136
Other study ID # RO04807
Secondary ID P01CA088960H-200
Status Completed
Phase Phase 2
First received
Last updated
Start date March 2005
Est. completion date March 2016

Study information
Verified date August 2021
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the clinical feasibility and efficacy of uing IMRT to escalate the biologically effective dose to the pelvic lymph nodes in a short course of radiation therapy. An increased total and biologically effective dose will be delivered to the pelvic lymph nodes (56 Gy at 2 Gy/fraction). The prostate will receive standard "short course" IMRT of radiation (70 Gy at 2.5 Gy/fraction).

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Prostate cancer stage T-T3 - Predicted risk of lymph node involvement > 15% - Gleason > 7 Exclusion Criteria: - Distance metastases - Use of anti-coagulant therapy

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• radiotherapy
prostate radiation to 70Gy; nodal radiation to 56Gy

Locations
Country Name City State
United States University Of Wisconsin Hospital and Clinics Madison Wisconsin

Sponsors (2)
Lead Sponsor Collaborator
University of Wisconsin, Madison National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants Experiencing Expected Toxicities Tolerances to high dose RT to Pelvic Lymph nodes in treatment of prostate cancer; measured by participants experiencing expected toxicities. Up to 5 years
Secondary To Evaluate Local Tumor Control and Biochemical Progression-free and Metastasis-free Survival Clinically evaluate local tumor control and biochemical progression-free and metastasis-free survivals. 5 years
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