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Cross-linked Hyaluronan Gel Reduces Rectal Toxicity Due to Radiation Therapy for Prostate Cancer

NCT00882232 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-02-15

No results posted yet for this study

Summary

The primary purpose of this study is to determine if cross-linked hyaluronan gel reduces the dose of radiation delivered to the rectum and the rectal toxicity of radiotherapy for localized prostate cancer.

Conditions

Interventions

DEVICE

Cross-linked hyaluronan gel

Single, transperitoneal injection of 9 mL cross-linked hyaluronan gel into anterior perirectal fat under anesthesia. The gel is injected prior to the start of radiotherapy and is absorbed by the body over several months. It increases the seapartion between the prostate and rectum by 1/3" to 2/3" at the start of radiotherapy.

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • Cancer Center of Irvine

    lead OTHER

Principal Investigators

  • Kenneth M Tokita, MD · Cancer Center of Irvine

  • Richard B Wilder, MD · Cancer Center of Irvine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00882232 on ClinicalTrials.gov