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Phase II Study of Craniospinal and Posterior Fossa Irradiation Using Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: Assessment of Acute and Long Term Sequelae


Phase 2
3 Years
21 Years
Open (Enrolling)
Both
Brain and Central Nervous System Tumors, Long-term Effects Secondary to Cancer Therapy in Children

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Trial Information

Phase II Study of Craniospinal and Posterior Fossa Irradiation Using Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: Assessment of Acute and Long Term Sequelae


OBJECTIVES:

- Determine the 3-year incidence and severity of ototoxicity in young patients with
medulloblastoma or pineoblastoma treated with adjuvant proton beam craniospinal and
posterior fossa radiotherapy.

- Determine the incidence of primary hypothyroidism and other endocrine dysfunction
(neuroendocrine and end organ) in patients treated with this regimen.

- Determine the incidence and severity of neurocognitive abnormalities in patients
treated with this regimen.

- Determine the acute side effects of this regimen, including esophagitis, upper and
lower gastrointestinal tract disease, and weight loss, in these patients.

- Determine the 3-year progression-free survival rate of patients treated with this
regimen.

OUTLINE: Patients are stratified according to risk (standard vs high).

Patients receive proton beam craniospinal and posterior fossa radiotherapy once daily 5 days
a week for 6-8 weeks*.

NOTE: *Unless otherwise specified by a co-existing protocol.

Patients undergo neurocognitive evaluation at baseline or within 3 months after completion
of radiotherapy and then at 1, 3, and 5 years. Patients also undergo endocrine evaluation at
baseline and then annually for 5 years; and audiology evaluation at baseline, before each
course of cisplatin-based chemotherapy (if receiving this), and then annually for 5 years.

After completion of study treatment, patients are followed every 3-6 months for 2-5 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Ototoxicity as measured by Common Toxicity Criteria (CTC) v3.0

Outcome Time Frame:

Annually

Safety Issue:

No

Principal Investigator

Nancy J. Tarbell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

CDR0000415841

NCT ID:

NCT00105560

Start Date:

May 2002

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Long-term Effects Secondary to Cancer Therapy in Children
  • long-term effects secondary to cancer therapy in children
  • untreated childhood medulloblastoma
  • untreated childhood pineoblastoma
  • Medulloblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Pinealoma

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617