NCT01219790

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

STUDY OF PHASE ID'ACIDE ZOLEDRONIC ASSOCIATED WITH A STRONG DOSE Hypofractionated Radiotherapy in Bone Metastases Vertebral Prostate Adenocarcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Institut Cancerologie de l'Ouest · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Prostate Adenocarcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-11-01
• Completion: 2015-11-01
• First posted: 2010-10-13
• Last updated: 2016-04-19

Locations

3 sites across 1 country: France