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

Prostate Adenocarcinoma Clinical Trial

— GEMO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219790
• Other study ID #: BRD 10/2-S
• Status: Completed
• Phase: Phase 1
• First received: October 11, 2010
• Last updated: April 18, 2016
• Start date: October 2010
• Est. completion date: November 2015

Study information

• Verified date: April 2016
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : Afssaps
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	Centre Léon Bérard	Lyon
France	Centre René Gauducheau	Saint Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological toxicity was defined as NCI-CTC grade V4.de greater than 2.		12 months	Yes