N/A N=59 Treatment

Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or Pineoblastoma

Brain and Central Nervous System Tumors · Long-term Effects Secondary to Cancer Therapy in Children

Bottom Line

View on ClinicalTrials.gov: NCT00105560 ↗

Enrolled (actual)

Serious AEs

22.0%

Results posted

Aug 2017

Primary outcome: Primary: Cumulative Incidence of Ototoxicity — 12; 16; 16; 15 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: radiation therapy (Radiation)
Age: Pediatric, Adult · 3+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Cumulative Incidence of Ototoxicity	12; 16; 16; 15; 20; 20	—
SECONDARY Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 3 Years	27; 28; 25; 22; 23; 20	—
SECONDARY Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 5 Years	55; 58; 50; 46; 50; 40	—
SECONDARY Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years	27; 55; 63; 22; 46; 55	—
SECONDARY Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years	27; 55; 63; 22; 46; 55	—
SECONDARY Mean Change Per-Year in Neurocognitive Outcomes	-1.5; -1.3; -.4; -0.8; -2.4	—
SECONDARY Progression Free Survival	80; 75; 85; 81; 70; 63	—
SECONDARY Overall Survival	83; 81; 86; 86; 75; 68	—

Summary

RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue. PURPOSE: This phase II trial is studying how well proton beam radiation therapy works in treating young patients who have undergone biopsy or surgery for medulloblastoma or pineoblastoma.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed medulloblastoma or pineoblastoma
Standard-risk or high-risk disease
Must have undergone biopsy or attempted surgical resection of the tumor within the past 35 days
Requires craniospinal irradiation

PATIENT CHARACTERISTICS:

Age

3 to 21

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No more than 1 prior chemotherapy regimen
No prior IV or intrathecal methotrexate
No prior intrathecal thiotepa
Concurrent cisplatin-based chemotherapy, including chemotherapy administered on another study, allowed

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy

Surgery

See Disease Characteristics

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00105560). 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.