TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention
NCT ID: NCT01613482
Last Updated: 2012-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
13 participants
INTERVENTIONAL
2007-10-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Without cerebral prophylactic radiation
Trastuzumab
Weekly, 2mg/kg of corporal weight
Other chemotherapy in association with Trastuzumab
other chemotherapy is possible to associate with Trastuzumab as well as a change of chemotherapy protocol is possible while maintening Trastuzumab 8 weeks is required between last injection of chemotherapy and first radiotherapy session
Arm B
With cerebral prophylactic radiation
cerebral prophylactic radiation
24Gy, 12 fractions of 2 Gy
Trastuzumab
Weekly, 2mg/kg of corporal weight
Other chemotherapy in association with Trastuzumab
other chemotherapy is possible to associate with Trastuzumab as well as a change of chemotherapy protocol is possible while maintening Trastuzumab 8 weeks is required between last injection of chemotherapy and first radiotherapy session
Interventions
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cerebral prophylactic radiation
24Gy, 12 fractions of 2 Gy
Trastuzumab
Weekly, 2mg/kg of corporal weight
Other chemotherapy in association with Trastuzumab
other chemotherapy is possible to associate with Trastuzumab as well as a change of chemotherapy protocol is possible while maintening Trastuzumab 8 weeks is required between last injection of chemotherapy and first radiotherapy session
Eligibility Criteria
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Inclusion Criteria
* Visceral metastasis, only or multiple
* First line metastasis treatment by Trastuzumab in association with chemotherapy
* Good general conditions: OMS=\<2 or Karnofsky \>=70%
* Age \> 18 years and \< 70 years
* Life expectancy \>=3 mois
* No Trastuzumab since more of 6 months
* No cerebral metastasis (MRI)
* Efficacy contraception for women with genital capacities
* Consent signed by the patient
Exclusion Criteria
* Psychiatric decease
* Prior cerebral radiotherapy,
* Geographical constraint, compromising the fallow of patients
* Infectious or other serious pathology, likely to stop the treatment
* Positive serology (HIV, hBC, hBS)
* Inclusion in an other clinical trial or in the 4 weeks before th inclusion
* Pregnant or breastfeeding women
18 Years
70 Years
FEMALE
No
Sponsors
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Centre Oscar Lambret
OTHER
Responsible Party
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Principal Investigators
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Locations
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Centre Paul Papin
Angers, , France
Centre Hospitalier
Boulogne-sur-Mer, , France
Centre Maurice Tubiana
Caen, , France
Centre G-François Baclesse
Caen, , France
Centre Léonard de Vinci
Dechy, , France
Centre Médical de Forcilles
Forcilles-attilly, , France
Clinique des Ormeaux- Vauban
Le Havre, , France
Centre Bourgogne
Lille, , France
Centre Oscar LAMBRET
Lille, , France
CHU Dupuytren
Limoges, , France
Clinique Clinique Clementville
Montpellier, , France
Centre Azuréen de Cancérologie
Mougins, , France
Centre Hospitalier de Mulhouse
Mulhouse, , France
Centre Catherine de Sienne
Nantes, , France
Clinique Hartmann
Neuilly-sur-Seine, , France
Centre Antoine Lacassagne
Nice, , France
Centre médical Oncogard
Nîmes, , France
Hôpital Tenon
Paris, , France
Centre Catalan d'Oncologie
Perpignan, , France
Centre Hospitalier LYON SUD
Pierre-Bénite, , France
Centre René Huguenin
Saint-Cloud, , France
Centre Etienne DOLET
Saint-Nazaire, , France
Centre de Cancérologie Paris Nord
Sarcelles, , France
Oncorad Garonne
Toulouse, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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TSARINE 0602
Identifier Type: -
Identifier Source: org_study_id
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