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A Phase III, Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy With or Without RSR13 in Patients With Brain Metastases

Phase 3
18 Years
Not Enrolling
Metastatic Cancer

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Trial Information

A Phase III, Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy With or Without RSR13 in Patients With Brain Metastases


- Compare the median survival time in patients with brain metastases after receiving
treatment with whole brain radiotherapy with or without RSR13.

- Compare the response rate to these treatment regimens in these patients.

- Compare the time to progression after receiving these treatment regimens in these

- Compare quality of life in these patients receiving these treatment regimens.

- Compare cause of death (neurologic vs nonneurologic death) in these patients after
receiving these treatment regimens.

- Determine the safety of RSR13 in these patients.

- Assess the pharmacokinetics of RSR13 in these patients.

OUTLINE: This is a randomized, open label, comparative, multicenter study. Patients are
stratified according to the Radiation Therapy Oncology Group RPA Class (I vs II). Patients
are further stratified within the RPA class II stratum according to site of primary cancer
(non-small cell lung cancer vs breast vs other). Patients are randomized to one of two
treatment arms.

- Arm I: Patients receive whole brain radiotherapy 5 days a week for two weeks in
conjunction with supplemental oxygen breathing.

- Arm II: Patients receive RSR13 IV over 30 minutes followed by whole brain radiotherapy
and supplemental oxygen breathing as in arm I.

Quality of life is assessed at the first and last day of radiotherapy, at 1 month, 3 months,
and then every 3 months until disease progression.

Patients are followed at 1 month, 3 months, every 3 months until disease progression, and
then for survival.

PROJECTED ACCRUAL: A maximum of 408 (204 per treatment arm) patients will be accrued for
this study.

Inclusion Criteria


- Radiographically, histologically, or cytologically confirmed brain metastases with
histologically or cytologically confirmed primary malignancy except the following:

- Small cell lung cancer, germ cell tumors, and lymphomas

- No leptomeningeal metastases



- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Not specified


- Hemoglobin at least 10 g/dL

- WBC at least 2,000/mm3

- Platelet count at least 75,000/mm3


- Bilirubin no greater than 2.0 mg/dL

- ALT and AST no greater than 3 times upper limit of normal


- Creatinine no greater than 2.0 mg/dL


- Forced vital capacity and forced expiratory volume at least 50% of normal in patients
with significant intrathoracic tumor involvement, chronic obstructive pulmonary
disease, interstitial lung disease, or pulmonary embolism

- Resting and exercise oxygen saturation at least 90% on room air


- No other concurrent active malignancy from a second histologic site

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy:

- No prior biologic therapy or immunotherapy for brain metastases

- At least 28 days since prior investigational biologic therapy


- No prior chemotherapy for brain metastases

- No chemotherapy for brain metastases for at least one month following radiation

- At least 7 days since prior chemotherapy for primary tumor or extracranial metastases

- No planned chemotherapy during radiation therapy

Endocrine therapy:

- No prior hormonal therapy for brain metastases

- Prior or concurrent corticosteroid therapy allowed


- No prior whole brain radiotherapy for brain metastases

- No prior stereotactic radiosurgery for brain metastases


- Prior surgery allowed for brain metastases if at least one measurable lesion remains


- At least 28 days since prior investigational drug or device

- No prior RSR13

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Edward G. Shaw, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • tumors metastatic to brain
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Akron City Hospital Akron, Ohio  44304
Arizona Cancer Center Tucson, Arizona  85724
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Colorado Cancer Center Denver, Colorado  80262
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
Cooper Hospital/University Medical Center Camden, New Jersey  08103
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
State University of New York - Upstate Medical University Syracuse, New York  13210
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
St. Joseph's Hospital and Medical Center Phoenix, Arizona  85001-2071
Harbor Hospital Center Baltimore, Maryland  21225
Akron General Medical Center Akron, Ohio  44302
Massey Cancer Center Richmond, Virginia  23298-0037
Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee, Wisconsin  53295
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Lahey Clinic - Burlington Burlington, Massachusetts  01805
Monmouth Medical Center Long Branch, New Jersey  07740-6395
Ochsner Clinic New Orleans, Louisiana  70121
California Cancer Care, Inc. Greenbrae, California  94904-2007
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Alta Bates Comprehensive Cancer Center Berkeley, California  94704
Bismarck Cancer Center Bismarck, North Dakota  58501
U.S. Oncology Research Inc. Houston, Texas  77060
Comprehensive Cancer Care Specialists of Boca Raton Boca Raton, Florida  33428
Tower Hematology Oncology Medical Group Los Angeles, California  90048
Scripps Green Hospital & Scripps Clinic La Jolla, California  92037
Citrus Memorial Hospital Inverness, Florida  34452
St. Agnes Healthcare Baltimore, Maryland  21229
East Coast Radiation Oncology Toms River, New Jersey  08755
Millard Fillmore Hospital Buffalo, New York  14209
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group Memphis, Tennessee  38119
Memphis Regional Brain Tumor Center Memphis, Tennessee  38104
Center for Radiation Oncology Danville, Virginia  24541