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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00875355
First received: April 2, 2009
Last updated: August 25, 2009
Last verified: July 2009
History of Changes
  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:

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 June 17, 2013