Hypofractionated Radiotherapy Versus Stereotactic Irradiation With Hyaluronic Acid

NCT02361515 | Completed DMC

• 1 other identifier: 2014-846
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Prostate; Hypofractionated radiotherapy; Stereotactic irradiation; Spacer; Rectal and bladder toxicities

Outcome Measures

Primary Outcomes (1)

• Number of patients with late urinary toxicities of grade ≥ 2 after moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and after stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy).

  Late urinary toxicities of grade ≥ 2 assessed using the Common Toxicity Criteria for Adverse Effects ( CTCAE) v 4.0 classification from 3 months to 3 years.

  Follow-up at ≥ 3 months after the radiotherapy and up to 3 years.

Secondary Outcomes (4)

• Survival rates without biological relapse in both arms.

  3 years.

• Evaluation and comparison of the acute urinary and rectal toxicities in both arms.

  3 months: evaluation at 3 months.

• Evaluation and comparison of the sexual preservation rates in both arms.

  3 years.

• Late rectal toxicities in both arms, for the evaluation of the hyaluronic acid efficacy to preserve the rectal wall in both approaches.

  3 years.

Study Arms (2)

Moderate Hypofractionated radiotherapy (62Gy)

ACTIVE COMPARATOR

20 fractions of 3.1Gy

Radiation: Moderate hypofractionated radiotherapy

Stereotactic radiotherapy (37.5Gy)

EXPERIMENTAL

5 fractions of 7.5Gy)

Radiation: Stereotactic radiotherapy

Interventions

Moderate hypofractionated radiotherapy RADIATION

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

Moderate Hypofractionated radiotherapy (62Gy)

Stereotactic radiotherapy RADIATION

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

Stereotactic radiotherapy (37.5Gy)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age superior or equal to 18 years and inferior to 80 years.
• patient with a low- to intermediate-risk prostate cancer, according to D'Amico classification, for an exclusive irradiation.
• prostate cancer histologically proven.
• performance index OMS (World Health Organization) of grade 0-2.
• indication of external beam radiotherapy validate by the medical commission of the institution.
• IPSS (International Prostate Symptom Score \< 15/35 (without alpha-blocker).
• the signed consent form.

You may not qualify if:

• Rectal surgery antecedents.
• prostate resection less than 6 mois.
• Involvement of the seminal vesicles or of the capsule on MRI.
• patient who can't cooperate during the treatment.
• pelvic irradiation antecedents.
• antecedents of inflammatory intestinal pathologies.
• neoplasia.
• patients treated with anti-neoplastic or anti-angiogenic or with other treatments used in rheumatology and which may include methotrexate (in order not to have a radiosensitizing effect).
• patients receiving anticoagulant treatment.
• other undergoing study that may interfere with the present study.
• patient under legal protection measure.
• hypersensitivity to hyaluronic acid.
• patient with auto-immune disease.
• patient receiving immunosuppressive medication.
• severe allergies.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (7)

Clinique Claude Bernard Service de radiothérapie CMCO Claude Bernard

Albi, 81000, France

Location

Centre Georges Francois Leclerc

Dijon, 21079, France

Location

Institut Paoli Calmettes

Marseille, 13009, France

Location

Site Hospitalier Nord Boulevard Jacques Monod

Nantes, 44805, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Institut de Cancérologie de la Loire

Saint-Etienne, 42270, France

Location

Groupe ONCORAD Clinique Pasteur

Toulouse, 31300, France

Location

Related Publications (1)

• Jmour O, Benna M, Champagnol P, Ben Mrad M, Hamrouni A, Obeid L, Lahmamssi C, Bousarsar A, Vial N, Rehailia-Blanchard A, Sotton S, Lan M, Langrand-Escure J, Vallard A, Magne N. CBCT evaluation of inter- and intra-fraction motions during prostate stereotactic body radiotherapy: a technical note. Radiat Oncol. 2020 Apr 19;15(1):85. doi: 10.1186/s13014-020-01534-2.

  PMID: 32307017 DERIVED

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 11, 2015
• Study Start: March 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

FR (7)