Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Primary Central Nervous System (CNS) Germ Cell Tumor
Status: | Completed |
---|---|
Conditions: | Brain Cancer, Brain Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 3 - 25 |
Updated: | 9/9/2018 |
Start Date: | January 2007 |
End Date: | May 2009 |
Radiotherapy Alone Versus Chemotherapy Followed By Response-Based Radiotherapy For Newly Diagnosed Primary CNS Germinoma
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or
die. It is not yet known whether radiation therapy alone is as effective as chemotherapy plus
radiation therapy in treating germ cell tumor.
PURPOSE: This randomized phase III trial is studying radiation therapy alone to see how well
it works compared to chemotherapy and radiation therapy in treating patients with newly
diagnosed primary CNS germ cell tumor.
chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or
die. It is not yet known whether radiation therapy alone is as effective as chemotherapy plus
radiation therapy in treating germ cell tumor.
PURPOSE: This randomized phase III trial is studying radiation therapy alone to see how well
it works compared to chemotherapy and radiation therapy in treating patients with newly
diagnosed primary CNS germ cell tumor.
OBJECTIVES:
Primary
- Compare event-free survival and overall survival of patients with newly diagnosed
primary CNS germ cell tumor treated with conventional radiotherapy alone (regimen A) vs
chemotherapy followed by tumor response-based radiotherapy (regimen B).
Secondary
- Determine the complete response rate in patients treated with regimen B.
- Determine the acute and subacute toxicity of regimen B in these patients.
- Compare treatment-related morbidity, in terms of verbal learning and memory, executive
functioning, and quality of life, in patients treated with these regimens.
- Determine the prognostic value of baseline serum, lumbar, and intraventricular levels of
human chorionic gonadotropin levels from patients treated with these regimens.
- Determine the prognostic value of extent of disease (M+ vs modified M+ vs M0) on
event-free survival and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor
location (pineal vs suprasellar vs pineal + suprasellar or other), and disease stage
(disseminated vs occult multi-focal vs localized). Patients are randomized to 1 of 2
treatment regimens.
All patients undergo an operative procedure (endoscopic biopsy, stereotactic biopsy, or open
craniotomy) to confirm the diagnosis of pure germ cell germinoma followed by an
intraoperative and perioperative staging evaluation.
- Regimen A (radiotherapy only): Within 52 days of surgery, patients undergo standard-dose
radiotherapy once daily on days 1-5 for approximately 5-6 weeks.
- Regimen B (chemotherapy plus radiotherapy):
- Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and
etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2
courses.
Patients achieving a complete response (CR) proceed to reduced-dose radiotherapy. Patients
with minimal residual disease (MRD), a partial response (PR), or stable disease (SD) receive
chemotherapy courses 3 and 4 as outlined below. Patients with progressive disease undergo a
second surgical procedure for biopsy and are restaged. Patients with a confirmed diagnosis of
germ cell tumor with no change in tumor markers and no new lesions after restaging proceed to
chemotherapy courses 3 and 4.
- Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide
IV over 1 hour on days 2 and 3, and filgrastim (G-CSF) subcutaneously or IV beginning on
day 4 and continuing until blood counts recover. Treatment repeats every 21 days for 2
courses.
Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD,
or progressive disease are restaged. Patients with a confirmed diagnosis of germ cell tumor
after restaging undergo standard radiotherapy as in regimen A.
- Reduced-dose radiotherapy: Within 6 weeks of starting course 4, patients undergo
lower-dose radiotherapy once daily on days 1-5 for 5 weeks.
Treatment in both regimens continues in the absence of unacceptable toxicity or in the event
that a non-germinomatous germ cell tumor is detected.
Quality of life and neuropsychological function within the domains of intelligence,
attention-concentration, memory, and executive functioning are assessed at 9, 30, and 60
months after diagnosis.
Patients are followed every 4 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 225 patients (approximately 112 per treatment regimen) will be
accrued for this study within 5 years.
Primary
- Compare event-free survival and overall survival of patients with newly diagnosed
primary CNS germ cell tumor treated with conventional radiotherapy alone (regimen A) vs
chemotherapy followed by tumor response-based radiotherapy (regimen B).
Secondary
- Determine the complete response rate in patients treated with regimen B.
- Determine the acute and subacute toxicity of regimen B in these patients.
- Compare treatment-related morbidity, in terms of verbal learning and memory, executive
functioning, and quality of life, in patients treated with these regimens.
- Determine the prognostic value of baseline serum, lumbar, and intraventricular levels of
human chorionic gonadotropin levels from patients treated with these regimens.
- Determine the prognostic value of extent of disease (M+ vs modified M+ vs M0) on
event-free survival and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor
location (pineal vs suprasellar vs pineal + suprasellar or other), and disease stage
(disseminated vs occult multi-focal vs localized). Patients are randomized to 1 of 2
treatment regimens.
All patients undergo an operative procedure (endoscopic biopsy, stereotactic biopsy, or open
craniotomy) to confirm the diagnosis of pure germ cell germinoma followed by an
intraoperative and perioperative staging evaluation.
- Regimen A (radiotherapy only): Within 52 days of surgery, patients undergo standard-dose
radiotherapy once daily on days 1-5 for approximately 5-6 weeks.
- Regimen B (chemotherapy plus radiotherapy):
- Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and
etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2
courses.
Patients achieving a complete response (CR) proceed to reduced-dose radiotherapy. Patients
with minimal residual disease (MRD), a partial response (PR), or stable disease (SD) receive
chemotherapy courses 3 and 4 as outlined below. Patients with progressive disease undergo a
second surgical procedure for biopsy and are restaged. Patients with a confirmed diagnosis of
germ cell tumor with no change in tumor markers and no new lesions after restaging proceed to
chemotherapy courses 3 and 4.
- Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide
IV over 1 hour on days 2 and 3, and filgrastim (G-CSF) subcutaneously or IV beginning on
day 4 and continuing until blood counts recover. Treatment repeats every 21 days for 2
courses.
Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD,
or progressive disease are restaged. Patients with a confirmed diagnosis of germ cell tumor
after restaging undergo standard radiotherapy as in regimen A.
- Reduced-dose radiotherapy: Within 6 weeks of starting course 4, patients undergo
lower-dose radiotherapy once daily on days 1-5 for 5 weeks.
Treatment in both regimens continues in the absence of unacceptable toxicity or in the event
that a non-germinomatous germ cell tumor is detected.
Quality of life and neuropsychological function within the domains of intelligence,
attention-concentration, memory, and executive functioning are assessed at 9, 30, and 60
months after diagnosis.
Patients are followed every 4 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 225 patients (approximately 112 per treatment regimen) will be
accrued for this study within 5 years.
DISEASE CHARACTERISTICS:
- Histologically confirmed primary CNS pure germ cell tumor
- Diagnosed within the past 31 days
- Meets any 1 OR none (i.e., M0 [localized disease]) of the following staging criteria:
- M+ (disseminated disease)
- Leptomeningeal or intraventricular metastases visualized on MRI scans of the
brain and spine
- Clumps of tumor cells on lumbar cerebrospinal fluid (CSF) cytology
- Visible tumor studding the walls of the lateral or third ventricles noted
during endoscopy or surgery
- Primary tumor arising within the parenchyma of the brain, brainstem, or
spinal cord
- Measurable multi-focal tumors arising in both the pineal and suprasellar
regions (i.e., multiple midline tumors)
- Infiltrative, intra-axial extension on brain MRI > 1 cm beyond enhancing
tumor
- Modified M+ (occult multi-focal disease)
- M0 at diagnosis with a localized pineal region tumor with signs and symptoms
of diabetes insipidus without measurable disease in the suprasellar region
- Lumbar CSF assay meeting criteria for the following marker profiles:
- Serum and CSF beta human chorionic gonadotropin (β-HCG) ≤ 50 IU/dL
- Serum alpha fetoprotein (AFP) ≤ 10 IU/L AND ≤ institutional norm
- CSF AFP ≤ 2.0 IU/L AND ≤ institutional norm
PATIENT CHARACTERISTICS:
Age
- 3 to 25
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,000/mm^3
- Platelet count > 100,000/mm^3 (transfusion independent)
- Hemoglobin > 10.0 g/dL (transfusion allowed)
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 times ULN
Renal
- Creatinine adjusted according to age as follows*:
- No greater than 0.4 mg/dL (≤ 5 months)
- No greater than 0.5 mg/dL (6 months -11 months)
- No greater than 0.6 mg/dL (1 year-23 months)
- No greater than 0.8 mg/dL (2 years-5 years)
- No greater than 1.0 mg/dL (6 years-9 years)
- No greater than 1.2 mg/dL (10 years-12 years)
- No greater than 1.4 mg/dL (13 years and over [female])
- No greater than 1.5 mg/dL (13 years to 15 years [male])
- No greater than 1.7 mg/dL (16 years and over [male]) AND
- Creatinine clearance OR radioisotope glomerular filtration rate > 70 mL/min
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Euthyroid (with or without levothyroxine sodium therapy) as determined by normal T4 ±
thyroid-stimulating hormone levels*
- Diabetes insipidus allowed provided patient is relatively stable on desmopressin
acetate
- Normal endogenous cortisol function*
- Adequate antidiuretic hormone reserves* NOTE: *Unless receiving replacement therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Concurrent replacement hormones allowed (e.g., corticosteroids, levothyroxine sodium,
and desmopressin acetate)
Radiotherapy
- Not specified
Surgery
- Prior surgery for germ cell tumor allowed
Other
- No other prior therapy for germ cell tumor
- Concurrent anticonvulsants allowed
We found this trial at
96
sites
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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1201 Camino de Salud Northeast
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4900 Mueller Boulevard
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(512) 324-0000
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Charlotte, North Carolina 28204
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Cincinnati, Ohio 45229
1-513-636-4200
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115 Business loop 70 w
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(573) 882-2100
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(803) 296-3000
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(214) 645-8300
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11234 Anderson Street
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Long Beach, California 90806
Long Beach, California 90806
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(407) 303-1700
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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593 Eddy Street
Providence, Rhode Island 02903
Providence, Rhode Island 02903
401-444-4000

Rhode Island Hospital Comprehensive Cancer Center The Comprehensive Cancer Center at Rhode Island Hospital is...
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601 Elmwood Avenue
Rochester, New York 14642
Rochester, New York 14642
(585) 275-5830

James P. Wilmot Cancer Center at University of Rochester Medical Center The Wilmot Cancer Center...
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7700 Floyd Curl Dr
San Antonio, Texas 78229
San Antonio, Texas 78229
(210) 575-7000

Methodist Children's Hospital of South Texas Methodist Children
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4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000

University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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3001 W Dr Martin L King Jr
Tampa, Florida 33607
Tampa, Florida 33607
(813) 870-4123

St. Joseph's Cancer Institute at St. Joseph's Hospital St. Joseph's Hospital is known for its...
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Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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1415 Tulane Ave., HC-62
Alexandria, Louisiana 70112
Alexandria, Louisiana 70112
504-988-6121

Tulane Cancer Center Office of Clinical Research As an academic cancer center, Tulane offers our...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 778-1900

Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Birmingham, Alabama 35294
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101 Manning Drive
Chapel Hill, North Carolina 27514
Chapel Hill, North Carolina 27514
(919) 966-0000

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill One of the...
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3110 MacCorkle Ave. S.E.
Charleston, West Virginia 25304
Charleston, West Virginia 25304
304-347-1206

West Virginia University Health Sciences Center - Charleston The West Virginia University Robert C. Byrd...
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Children's Memorial Hospital, Chicago Ann & Robert H. Lurie Children
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4760 Sunset Blvd
Downey, California 90027
Downey, California 90027
(323) 783-6151

Southern California Permanente Medical Group We
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Farmington, Connecticut 06360
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Baylor University Medical Center - Houston Baylor University Medical Center in Dallas began in 1903...
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East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
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4018 W Capitol Ave.
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
(501) 296-1200

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences The Winthrop P. Rockefeller...
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8700 Beverly Blvd.
Los Angeles, California 90048
Los Angeles, California 90048
1-800-233-2771

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Cedars-Sinai's Samuel Oschin Comprehensive Cancer Institute...
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Marshfield Clinic - Marshfield Center The Clinic was incorporated under Wisconsin law in 1916 and...
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9000 W Wisconsin Ave
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 266-2000

Midwest Children's Cancer Center at Children's Hospital of Wisconsin We are the region's only independent...
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2525 Chicago Ave
Minneapolis, Minnesota 55404
Minneapolis, Minnesota 55404
(612) 813-6000

Children's Hospitals and Clinics of Minnesota - Minneapolis Children's Hospitals and Clinics of Minnesota is...
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195 Little Albany St
New Brunswick, New Jersey 08903
New Brunswick, New Jersey 08903
(732) 235-2465

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School As New...
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Saint Peter's University Hospital Located in New Brunswick, NJ, Saint Peter's University Hospital has been...
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160 E 34th St
New York, New York 10016
New York, New York 10016
(212) 731-5001

NYU Cancer Institute at New York University Medical Center The Perlmutter Cancer Center takes a...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Advocate Christ Medical Center Advocate Health Care, named among the nation
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Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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3 Edmund D. Pellegrino Road
Stony Brook, New York 11794
Stony Brook, New York 11794
(631) 638-1000

Stony Brook University Cancer Center Ask a cancer survivor. Having highly advanced care close to...
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6900 Georgia Ave NW
Washington, District of Columbia 20307
Washington, District of Columbia 20307
(202) 782-6849

Walter Reed Army Medical Center The Walter Reed National Military Medical Center is one of...
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111 Michigan Ave NW
Washington, District of Columbia
Washington, District of Columbia
(202) 476-5000

Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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