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

Primary Purpose

Prostate Adenocarcinoma

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
external radiotherapy
Acide zoledronic
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma focused on measuring Patients with painful vertebral metastases with a prostate cancer with an indication of analgesic treatment.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Paul Papin
  • Centre Léon Bérard
  • Centre René Gauducheau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

irradiation + zometa

Arm Description

Outcomes

Primary Outcome Measures

Neurological toxicity was defined as NCI-CTC grade V4.de greater than 2.

Secondary Outcome Measures

Full Information

First Posted
October 11, 2010
Last Updated
April 18, 2016
Sponsor
Institut Cancerologie de l'Ouest
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1. Study Identification

Unique Protocol Identification Number
NCT01219790
Brief Title
ZOLEDRONIC ASSOCIATED With Hight Hypofractionated Radiotherapy Dose in Bone Metastases Vertebral Prostate Adenocarcinoma
Acronym
GEMO
Official Title
STUDY OF PHASE ID'ACIDE ZOLEDRONIC ASSOCIATED WITH A STRONG DOSE Hypofractionated Radiotherapy in Bone Metastases Vertebral Prostate Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma
Keywords
Patients with painful vertebral metastases with a prostate cancer with an indication of analgesic treatment.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
irradiation + zometa
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
external radiotherapy
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Acide zoledronic
Intervention Description
The administration of zoledronic acid as defined under the Authorisation on the Market.
Primary Outcome Measure Information:
Title
Neurological toxicity was defined as NCI-CTC grade V4.de greater than 2.
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Centre René Gauducheau
City
Saint Herblain
ZIP/Postal Code
44805
Country
France

12. IPD Sharing Statement

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

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