Informations générales (source: ClinicalTrials.gov)
Phase II Randomized Multicenter Study Comparing Brain Radiation in Combination With Temozolomide or Radiation Alone in Patients With Brain Metastases From Breast Cancer
Interventional
Phase 2
Institut Curie (Voir sur ClinicalTrials)
novembre 2007
29 juin 2024
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in
chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor
cells, either by killing the cells or by stopping them from dividing. It is not yet known
whether radiation therapy is more effective when given alone or together with
temozolomide in treating brain metastases secondary to breast cancer.
PURPOSE: This randomized phase II trial is studying how well radiation therapy given
together with temozolomide works compared with radiation therapy given alone in treating
women with brain metastases and breast cancer.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Youlia Kirova | Contact (sur clinicalTrials) | |||
Critères
Femme
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
- Unresectable disease or patient refused surgery
- Must have brain metastases
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Liver transaminases ≤ 1.5 times upper limit of normal (ULN)
- Creatinine < 1.5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No carcinomatous meningitis
- No history of cancer except for basal cell carcinoma of the skin or carcinoma in
situ of the cervix
- No other serious concurrent disease that is, in the opinion of the investigator,
likely to interfere with study evaluation and treatment
- No contraindications to treatment with temozolomide
- No psychological, familial, social, or geographic situations that preclude clinical
follow up
- No patient deprived of liberty or under guardianship
PRIOR CONCURRENT THERAPY:
- No prior brain radiotherapy
- At least 10 days since prior chemotherapy
- Diagnosis of breast cancer
- Unresectable disease or patient refused surgery
- Must have brain metastases
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Liver transaminases ≤ 1.5 times upper limit of normal (ULN)
- Creatinine < 1.5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No carcinomatous meningitis
- No history of cancer except for basal cell carcinoma of the skin or carcinoma in
situ of the cervix
- No other serious concurrent disease that is, in the opinion of the investigator,
likely to interfere with study evaluation and treatment
- No contraindications to treatment with temozolomide
- No psychological, familial, social, or geographic situations that preclude clinical
follow up
- No patient deprived of liberty or under guardianship
PRIOR CONCURRENT THERAPY:
- No prior brain radiotherapy
- At least 10 days since prior chemotherapy