Radiation Therapy With or Without Temozolomide in Treating Women With Brain Metastases and Breast Cancer

I

Institut Curie

Status and phase

Unknown
Phase 2

Conditions

Metastatic Cancer
Breast Cancer

Treatments

Drug: temozolomide
Radiation: radiation therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00875355
INCA-RECF0630
SCHER-CLCC-IC-RT-TEMODAL
CLCC-IC-2007-01
CLCC-IC-RT-TEMODAL
CDR0000633496
EUDRACT-2007-002531-83

Details and patient eligibility

About

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.

Full description

OBJECTIVES: Primary Compare the objective response rate at 6 weeks in women with brain metastases secondary to breast cancer treated with radiotherapy with vs without temozolomide. Secondary Evaluate the tolerability. Compare the duration of response. Compare local progression-free survival. Compare overall survival. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks. Arm II: Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks. After completion of study treatment, patients are followed at 3 and 6 months and then every 6 months for 2 years.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

100 participants in 2 patient groups

Arm I
Experimental group
Description:
Patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks.
Treatment:
Radiation: radiation therapy
Arm II
Experimental group
Description:
Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks.
Treatment:
Radiation: radiation therapy
Drug: temozolomide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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