ZOLEDRONIC ASSOCIATED With Hight Hypofractionated Radiotherapy Dose in Bone Metastases Vertebral Prostate Adenocarcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Centre René Gauducheau.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre René Gauducheau
ClinicalTrials.gov Identifier:
NCT01219790
First received: October 11, 2010
Last updated: October 12, 2010
Last verified: October 2010
  Purpose

This study will determine the delayed neurotoxicity (12 months) of a hypofractionated high dose irradiation (3 Gy x 9) associated with zoledronic acid.

The administration of zoledronic acid repeat dosages defined under the Authorisation on the Market.

All patients receive a total dose of 27 Gy divided into 3 fractions of 9 Gy performed at least 48 hours apart each, for a treatment to J1, J3 and J5.


Condition Intervention Phase
Prostate Adenocarcinoma
Radiation: external radiotherapy
Drug: Acide zoledronic
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: STUDY OF PHASE ID'ACIDE ZOLEDRONIC ASSOCIATED WITH A STRONG DOSE Hypofractionated Radiotherapy in Bone Metastases Vertebral Prostate Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Centre René Gauducheau:

Primary Outcome Measures:
  • Neurological toxicity was defined as NCI-CTC grade V4.de greater than 2. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: October 2010
Intervention Details:
    Radiation: external radiotherapy
    All patients receive a total dose of 27 Gy divided into 3 fractions of 9 Gy performed at least 48 hours apart each, for a treatment to J1, J3 and J5
    Drug: Acide zoledronic
    The administration of zoledronic acid as defined under the Authorisation on the Market.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adenocarcinoma of the prostate metastatic Age> 18 years3.

  • Life expectancy> 12 months;
  • Performance Index status <3 PSA ≥ 4 ng / ml Zoledronic acid treatment in progress as recommended by the Authority for the Marketing Creatinine clearance above 30 ml / min Lack of maintenance causing disabling pain not lying down long (30 minutes) No history of radiotherapy to the region to be irradiated Absence of neurological signs compression Distance between the metastasis and spinal cord ≥ 5 mm Absence of metastases unstable metastatic epidural spinal cord compression or may require surgery before radiotherapy

Exclusion Criteria:

  • Concomitant treatment with a drug testing, participation in another clinical trial within <30 days
  • Presence of central system nervous desease (symptoms or progressive), Patient with a severe neurological disease, current manifestations of peripheral neuropathy> grade 2 NCI-CTC V4 Existence of another severe pulmonary disease, liver or kidney, digestive likely to be exacerbated by treatment,
  • Untreated with zoledronic acid
  • Treatment with a bisphosphonate other than Zoledronic acid
  • Clinically significant hypersensitivity to zoledronic acid, other bisphosphonates or to any excipients in the formulation of Zometa.
  • Creatinine clearance below 30 ml / min
  • History of another primary cancer (except basal cell skin cancer)
  • Or demented patient with altered mental status who can not obtain informed consent. / Persons deprived of liberty or under guardianship
  • Pain not resulting in maintaining the prolonged supine position (30 minutes)
  • PSA below 4 ng / ml
  • History of radiotherapy in localized tumor site
  • Distance between the metastasis and spinal cord <5 mm
  • Monitoring impossible because of psychological, sociological or because of geographical distance.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01219790

Locations
France
Centre Paul Papin Not yet recruiting
Angers, France, 49000
Contact: Patrice Cellier, MD         p.cellier@unimedia.fr    
Centre Léon Bérard Not yet recruiting
Lyon, France, 69000
Contact: Christian Carrie, MD         CARRIE@lyon.fnclcc.fr    
Centre René Gauducheau Recruiting
Saint Herblain, France, 44805
Contact: Stéphane Supiot, MD     +33240679900        
Sponsors and Collaborators
Centre René Gauducheau
  More Information

No publications provided

Responsible Party: Mme Scotet-Cérato, Centre René Gauducheau
ClinicalTrials.gov Identifier: NCT01219790     History of Changes
Other Study ID Numbers: BRD 10/2-S
Study First Received: October 11, 2010
Last Updated: October 12, 2010
Health Authority: France : Afssaps

Keywords provided by Centre René Gauducheau:
Patients with painful vertebral metastases with a prostate cancer with an indication of analgesic treatment.

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Prostatic Neoplasms
Neoplasm Metastasis
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013