Clinical Trial Details
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NCT00276640 : Radiation Therapy or Combination Chemotherapy in Treating Patients With Clinically or Radiologically Progressive Low-Grade Gliomas
AgesMin: N/A Max: 18 Years

- Histologically confirmed low-grade glioma, of 1 of the following histologic subtypes:

- Pilocytic astrocytoma I° and variants

- Subependymal giant cell astrocytoma I°

- Dysembryoplastic neuroepithelial tumor I°

- Desmoplastic infantile ganglioglioma I°

- Ganglioglioma I° and II°

- Pleomorphic xanthoastrocytoma II°

- Oligodendroglioma II°

- Oligoastrocytoma II°

- Astrocytoma II°

- Fibrillary astrocytoma II°

- Protoplasmatic astrocytoma II°

- Gemistocytic astrocytoma II°

- Children with chiasmatic-hypothalamic tumors may be eligible without histological
diagnosis, if neuroradiologic findings meet unequivocal criteria for the presence of
a low-grade glioma

- Primary tumor localization: intracranial and/or spinal cord

- No diffuse intrinsic tumors of the pons, even if histologically an astrocytoma
I° or II° is diagnosed

- Exception: pontine glioma II° in neurofibromatosis type 1 (NF1) disease

- Children presenting with disseminated low-grade glioma will be eligible for the study

- All eligible patients without NF1 disease receiving chemotherapy as their first
nonsurgical therapy are eligible for randomization

- Children are eligible for the trial regardless of the presence of associated genetic
disease: NF1 disease will be the prominent one, all children with NF1 disease are
entered into the study arm III in case of an indication for nonsurgical therapy

- Patients presenting with rare intracranial neoplasms of low-grade malignancy, but
nonglial origin, may be followed according to the low-grade glioma strategy, but they
are not subject of this therapy trial.

- Data from these patients may be registered to learn about those therapeutic
interventions which may prove useful to these patients and to develop separate
strategies in the future

- Patients with choroid plexus papilloma should be entered into the SIOP-CPT study
(Prof. Dr. J. Wolff, M.D. Anderson Cancer Center, Houston, Texas)


- No preexisting impairments of health status, making the conduct of the study
impossible or ethically unwise

- No evidence of pregnancy or lactation period

- Pregnancy has to be prevented in fertile adolescent girls during chemotherapy by
reliable contraception methods (e.g., hormonal contraception)


- The tumor should not be pretreated with chemotherapy or radiotherapy

- Children treated with chemotherapy or radiotherapy prior to entering the study
will be evaluated separately

- Previous treatment with steroids is not considered a chemotherapeutic

- Surgery of any type and extent allowed

- Prior surgical resection of the tumor allowed

- Participation in another clinical study concurrently with this study (e.g.,
endocrinologic study) allowed provided it is not interfering with the present
treatment strategy

- No other concurrent chemotherapy

- Concurrent medication for associated or other conditions (e.g., hormone replacement,
anticonvulsants) that does not containing cytostatic drugs allowed
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