Overview

Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy in different ways with combination chemotherapy may kill any remaining tumor cells following surgery. It is not yet known which radiation therapy regimen combined with combination chemotherapy is more effective in treating medulloblastoma. PURPOSE: Randomized phase III trial to compare different radiation therapy regimens plus combination chemotherapy in treating children who have undergone surgery for medulloblastoma.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Leicester
Treatments:
Lomustine
Vincristine
Criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed medulloblastoma, including the following variants:

- Classic

- Nodular/desmoplastic

- Large cell

- Melanotic

- Medullomyoblastoma

- Prior total or subtotal surgical removal of tumor within the past 28-40 days

- No more than 1.5 cm^2 residual tumor by early postoperative MRI or CT scan

- No brainstem or supratentorial primitive neuroectodermal tumor

- No atypical teratoid rhabdoid tumor

- No known predisposition to medulloblastoma (e.g., Gorlin's syndrome)

- No CNS metastasis (supratentorial, arachnoid of the posterior fossa, or craniospinal
axis) by MRI

- No clinical evidence of metastasis outside the CNS

- No tumor cells in lumbar cerebrospinal fluid by cytospin

PATIENT CHARACTERISTICS:

Age

- 3 to 21

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Hematological function less than CTC grade 2

Hepatic

- Liver function less than CTC grade 2

Renal

- Renal function less than CTC grade 2

Other

- Not pregnant

- Fertile patients must use effective contraception

- Able to receive radiotherapy twice daily

- Vital functions within age-appropriate normal range

- Audiological function less than CTC grade 2

- No medical contraindication to radiotherapy or chemotherapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Concurrent dexamethasone as an antiemetic allowed, provided all other therapies have
failed

Radiotherapy

- No concurrent cobalt irradiation

Surgery

- See Disease Characteristics

Other

- No prior treatment for brain tumor or any other malignancy