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Hypofractionated Radiotherapy Versus Stereotactic Irradiation With Hyaluronic Acid

NCT02361515 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2022-03-17

No results posted yet for this study

Summary

The present randomized, open, multicentric Phase II trial, in parallel groups with two arms of treatment, compares the treatment A, moderate hypofractionated radiotherapy of 62Gy, to treatment B, stereotactic irradiation of 37.5 Gy with hyaluronic acid injection in the space between the prostate and the rectum to preserve the rectal-wall from high doses of irradiation. The study aims to assess the rates of late urinary toxicities of grade ≥ 2 induced by a moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and by a stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy), and the rectal toxicities after an injection of hyaluronic acid between the rectal wall and the prostate.

Ninety-six patients and 9 centers are included in the protocol.

Conditions

  • Prostatic Adenocarcinoma

Interventions

RADIATION

Moderate hypofractionated radiotherapy

Moderate hypofractionated radiotherapy of 62Gy in 20 fraction of 3.1Gy.

RADIATION

Stereotactic radiotherapy

Stereotactic radiotherapy of 37.5Gy in 5 fraction of 7.5Gy.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • France

Study Locations

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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 NCT02361515 on ClinicalTrials.gov