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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000068920 | Registry Identifier | PDQ (Physician Data Query) | |
| EU-20123 |
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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Tamoxifen may kill tumor cells by blocking the enzymes necessary for cell growth. Combining radiation therapy with tamoxifen may be effective in treating newly diagnosed brain stem glioma.
PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy and tamoxifen in treating children who have newly diagnosed brain stem glioma.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy once daily 5 days a week for 6 weeks. Within 2 weeks after the initiation of radiotherapy, patients receive oral high-dose tamoxifen once daily. Tamoxifen continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study within 4 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tamoxifen citrate | Drug | |||
| radiation therapy | Radiation |
DISEASE CHARACTERISTICS:
Newly diagnosed tumor of the brain stem (diffuse intrinsic lesion centered on the pons)
Radiological and clinical diagnostic criteria allowed (biopsy not required)
The following astrocytic tumors are allowed if histologically confirmed:
Less than 6 months since diagnosis
At least 1 of the following signs of brain stem tumor:
No focal lesions of the brain stem (either clearly marginated or cystic), cervicomedullary tumors, tumors predominately exophytic, or pontine tumors diagnosed as pilocytic on biopsy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Michalski, MD | Great Ormond Street Hospital for Children NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Our Lady's Hospital for Sick Children | Crumlin | 12 | Ireland | |||
| Birmingham Children's Hospital |
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| Birmingham |
| England |
| B4 6NH |
| United Kingdom |
| Bristol Royal Hospital for Children | Bristol | England | BS2 8BJ | United Kingdom |
| Addenbrooke's NHS Trust | Cambridge | England | CB2 2QQ | United Kingdom |
| St. James's Hospital | Leeds | England | LS9 7TF | United Kingdom |
| Leicester Royal Infirmary | Leicester | England | LE1 5WW | United Kingdom |
| Royal Liverpool Children's Hospital, Alder Hey | Liverpool | England | L12 2AP | United Kingdom |
| Saint Bartholomew's Hospital | London | England | EC1A 7BE | United Kingdom |
| Hospital for Sick Children NHS Trust | London | England | WC1N 3JH | United Kingdom |
| Middlesex Hospital- Meyerstein Institute | London | England | WIT 3AA | United Kingdom |
| Manchester Children's Hospitals (NHS Trust) | Manchester | England | M27 1HA | United Kingdom |
| Newcastle Upon Tyne Hospitals NHS Trust | Newcastle upon Tyne | England | NE7 7DN | United Kingdom |
| Queen's Medical Centre | Nottingham | England | NG7 2UH | United Kingdom |
| Oxford Radcliffe Hospital | Oxford | England | 0X3 9DU | United Kingdom |
| Children's Hospital - Sheffield | Sheffield | England | S10 2TH | United Kingdom |
| Southampton General Hospital | Southampton | England | SO16 6YD | United Kingdom |
| Royal Marsden Hospital | Sutton | England | SM2 5PT | United Kingdom |
| Royal Belfast Hospital for Sick Children | Belfast | Northern Ireland | BT12 6BE | United Kingdom |
| Aberdeen Royal Infirmary | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
| Royal Hospital for Sick Children | Edinburgh | Scotland | United Kingdom |
| Royal Hospital for Sick Children | Glasgow | Scotland | G3 8SJ | United Kingdom |
| Llandough Hospital | Penarth | Wales | CF64 2XX | United Kingdom |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |
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