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

NCT ID: NCT00875355

Last Updated: 2009-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30

Brief Summary

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.

Detailed 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.

Conditions

Breast Cancer; Metastatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Study Groups

Arm I

Patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks.

Group Type: EXPERIMENTAL

radiation therapy

Intervention Type: RADIATION

Patients undergo radiotherapy

Arm II

Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks.

Group Type: EXPERIMENTAL

temozolomide

Intervention Type: DRUG

Given orally

radiation therapy

Intervention Type: RADIATION

Patients undergo radiotherapy

Interventions

temozolomide

Given orally

Intervention Type: DRUG

radiation therapy

Patients undergo radiotherapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Curie

OTHER

Sponsor Role: lead

Principal Investigators

Youlia Kirova

Role: PRINCIPAL_INVESTIGATOR

Institut Curie

Locations

Institut Curie Hopital

Paris, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Youlia Kirova

Role: primary

33-44-32-4000

References

Cao KI, Lebas N, Gerber S, Levy C, Le Scodan R, Bourgier C, Pierga JY, Gobillion A, Savignoni A, Kirova YM. Phase II randomized study of whole-brain radiation therapy with or without concurrent temozolomide for brain metastases from breast cancer. Ann Oncol. 2015 Jan;26(1):89-94. doi: 10.1093/annonc/mdu488. Epub 2014 Oct 29.

Reference Type: DERIVED

PMID: 25355723 (View on PubMed)

Other Identifiers

CLCC-IC-RT-TEMODAL

Identifier Type: -

Identifier Source: secondary_id

CLCC-IC-2007-01

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0630

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2007-002531-83

Identifier Type: -

Identifier Source: secondary_id

SCHER-CLCC-IC-RT-TEMODAL

Identifier Type: -

Identifier Source: secondary_id

CDR0000633496

Identifier Type: -

Identifier Source: org_study_id