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
Recruitment status was Recruiting
Sponsor:
Centre René Gauducheau
Information provided by:
Centre René Gauducheau
ClinicalTrials.gov Identifier:
NCT01219790
First received: October 11, 2010
Last updated: October 12, 2010
Last verified: October 2010
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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