Clinical trial · Interventional

Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Primary Central Nervous System (CNS) Germ Cell Tumor

Radiotherapy Alone Versus Chemotherapy Followed By Response-Based Radiotherapy For Newly Diagnosed Primary CNS Germinoma

NCT00085098CI-TRIAL-00034754completedPhase 3Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Brain Tumor	Brain Neoplasm	ALIAS	0.90
Central Nervous System Tumor	Central Nervous System Neoplasm	ALIAS	0.90

Interventions

Interventions (6)

Intervention	Type	Mapped drug	Match
carboplatin	Drug	Carboplatin	ALIAS
cisplatin	Drug	Cisplatin	ALIAS
cyclophosphamide	Drug	Cyclophosphamide	ALIAS
etoposide	Drug	Etoposide	ALIAS
filgrastim	Biological	Filgrastim	ALIAS
radiation therapy	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Regimen A (radiotherapy only)
description
Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
interventionNames
1. Radiation: radiation therapy
type
EXPERIMENTAL
label
Regimen B (chemotherapy plus radiotherapy)
description
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. Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below. 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), subcutaneous (SC) 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 (PD) are restaged and may undergo standard radiation therapy as in regimen A. Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 3 Years
Maximum age: 25 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Jan 1, 2007
Primary completion: May 1, 2009
Completion: May 1, 2009
First posted: Jun 11, 2004
Last update posted: Sep 7, 2018
Results first posted: Nov 6, 2013
Enrollment: 24 (actual)
Lead sponsor: Children's Oncology Group NETWORK
Collaborators: National Cancer Institute (NCI)
Keywords: childhood central nervous system germ cell tumor

Data updated 22 days agoSource updated Sep 7, 2018source: clinicaltrials

Locations

Locations by country (107)

Country	Sites	Recruiting
United States	95	0
Canada	8	0
Australia	3	0
Puerto Rico