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

NCT ID: NCT00214136

Last Updated: 2021-08-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2016-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

prostate radiation to 70Gy, lymph nodes to 56Gy

Group Type EXPERIMENTAL

radiotherapy

Intervention Type RADIATION

prostate radiation to 70Gy; nodal radiation to 56Gy

Interventions

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radiotherapy

prostate radiation to 70Gy; nodal radiation to 56Gy

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Ritter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University Of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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https://cancer.wisc.edu/

University of Wisconsin Carbone Cancer Center

Other Identifiers

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P01CA088960

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-2004-0472

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-00947

Identifier Type: REGISTRY

Identifier Source: secondary_id

A533300

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\HUMAN ONCOLOGY

Identifier Type: OTHER

Identifier Source: secondary_id

RO04807

Identifier Type: -

Identifier Source: org_study_id

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