Radiation Therapy With or Without Temozolomide in Treating Women With Brain Metastases and Breast Cancer - Full Text View

Sponsor:	Institut Curie
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00875355

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Metastatic Cancer	Drug: temozolomide Radiation: radiation therapy	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	Phase II Randomized Multicenter Study Comparing Brain Radiation in Combination With Temozolomide or Radiation Alone in Patients With Brain Metastases From Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Temozolomide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response at 6 weeks as assessed by MRI and/or scan [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2007
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875355

Locations

France
Institut Curie Hopital	Recruiting
Paris, France, 75248
Contact: Youlia Kirova 33-44-32-4000

Sponsors and Collaborators

Institut Curie

Investigators

Principal Investigator:

Youlia Kirova

Institut Curie

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00875355 History of Changes
Other Study ID Numbers:	CDR0000633496, CLCC-IC-RT-TEMODAL, CLCC-IC-2007-01, INCA-RECF0630, EUDRACT-2007-002531-83, SCHER-CLCC-IC-RT-TEMODAL
Study First Received:	April 2, 2009
Last Updated:	August 25, 2009
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

tumors metastatic to brain
stage IV breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes

Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2012