Phase 2 N=378 Treatment

Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma

Brain Tumor · Central Nervous System Tumor

Bottom Line

View on ClinicalTrials.gov: NCT00027846 ↗

Enrolled (actual)

378

Serious AEs

27.0%

Results posted

Mar 2017

Primary outcome: Primary: Event-free Survival — 0.614; 0.685; 0.372 Probability of EFS at 5 years

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: filgrastim (Biological); carboplatin (Drug); cyclophosphamide (Drug); etoposide (Drug); vincristine sulfate (Drug); radiation therapy (Radiation); Mesna (Drug); therapeutic conventional surgery (Procedure)
Age: Pediatric, Adult · 1+ yrs
Sex: All
Sponsor: Children's Oncology Group
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Event-free Survival	0.614; 0.685; 0.372	—
SECONDARY Overall Survival	1; 0.862; 0.702	—
SECONDARY Rate of Gross-total or Near-total Resection and Second Surgery After Chemotherapy	76	—
SECONDARY Event-free Survival (EFS)	0.746; 0.607	—
SECONDARY Event-free Survival (EFS)	0.746; 0.607	—
SECONDARY Local Control and Patterns of Failure	6; 217; 29; 4; 57; 31	—

Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to determine the effectiveness of specialized radiation therapy either alone or after chemotherapy and second surgery in treating children who have undergone surgery for localized ependymoma.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed intracranial ependymoma
Differentiated ependymoma or anaplastic ependymoma
No primary spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma
No evidence of noncontiguous spread beyond primary site
Initial surgical resection within the past 56 days

PATIENT CHARACTERISTICS:

Age:

1 to 21

Performance status:

No restrictions

Life expectancy:

At least 2 months

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

Able to undergo MRI
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy

Endocrine therapy:

Prior or concurrent corticosteroids allowed

Radiotherapy:

No prior radiotherapy

Surgery:

See Disease Characteristics
More than 1 prior surgery allowed

Other:

No other prior treatment for ependymoma

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00027846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.