Clinical trial NCT01219790: ZOLEDRONIC ASSOCIATED With Hight Hypofractionated Radiotherapy Dose in Bone Metastases Vertebral Prostate Adenocarcinoma
Official title: STUDY OF PHASE ID'ACIDE ZOLEDRONIC ASSOCIATED WITH A STRONG DOSE Hypofractionated Radiotherapy in Bone Metastases Vertebral Prostate Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Adenocarcinoma
Keywords: Patients with painful vertebral metastases with a prostate cancer with an indication of analgesic treatment.
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Neurological toxicity was defined as NCI-CTC grade V4.de greater than 2.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Paul Papin
city: Lyon
country: France
facility: Centre Léon Bérard
city: Saint Herblain
country: France
facility: Centre René Gauducheau
Study officials:
References: