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


Phase 1
18 Years
N/A
Open (Enrolling)
Male
Prostate Adenocarcinoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

12 months

Safety Issue:

Yes

Authority:

France : Afssaps

Study ID:

BRD 10/2-S

NCT ID:

NCT01219790

Start Date:

October 2010

Completion Date:

Related Keywords:

  • Prostate Adenocarcinoma
  • Patients with painful vertebral metastases with a prostate cancer with an indication of analgesic treatment.
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms
  • Neoplasm Metastasis

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