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| ID | Type | Description | Link |
|---|---|---|---|
| CCLG-GC-1997-01 | |||
| EU-20579 | |||
| SIOP-CNS-GCT-96 |
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RATIONALE: Drugs used in chemotherapy, such as carboplatin, etoposide, ifosfamide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with radiation therapy may kill more tumor cells.
PURPOSE: This phase III trial is studying combination chemotherapy followed by radiation therapy to see how well it works compared to radiation therapy alone in treating patients with germ cell tumors in the brain.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a non-randomized, multicenter study. Patients are stratified according to tumor classification (pure CNS germinoma vs secreting germ cell tumor and embryonal carcinoma).
Patients in stratum I undergo biopsy or surgical resection and then begin radiotherapy with or without chemotherapy.
Stratum I (pure CNS germinoma [without elevated markers]): Patients receive 1 of 2 treatment options based on national/center standard:
Stratum II (secreting tumors and embryonal carcinoma): Patients receive etoposide phosphate IV over 1 hour on days 1-3, cisplatin IV over 1 hour on days 1-5, and ifosfamide IV over 22 hours on days 1-5. Treatment repeats every 3 weeks for up to 4 courses. Patients whose tumor markers do not return to normal after completion of chemotherapy are off protocol. Patients may undergo surgery after chemotherapy course 2 or 4 if required. After completion of chemotherapy and recovery from surgery, patients with nonmetastatic disease undergo radiotherapy to the tumor bed 5 day a week for 6 weeks, and patients with metastatic disease undergo radiotherapy to the cerebrum, spinal axis, and tumor bed for 7 weeks.
After completion of study treatment, patients are followed for 4 weeks and then periodically.
PROJECTED ACCRUAL: Approximately 500 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| cisplatin | Drug | |||
| etoposide phosphate | Drug | |||
| ifosfamide | Drug | |||
| adjuvant therapy | Procedure | |||
| conventional surgery | Procedure | |||
| neoadjuvant therapy | Procedure | |||
| radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | ||
| Event-free survival |
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DISEASE CHARACTERISTICS:
Clinical and radiological evidence of intracranial germ cell tumor, classified as 1 of the following:
Germinoma
Secreting germ cell tumor
Elevated tumor markers in serum and/or cerebral spinal fluid as evidenced by any of the following:
Any tumor containing 1 of these components:
Yolk sac tumor
Choriocarcinoma
Embryonal tumor
Diagnosis confirmed by histology or elevated serum markers
Metastatic or nonmetastatic disease
Study treatment must begin ≤ 4 weeks after diagnosis
No pure immature or mature teratomas
The following additional patients are eligible:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| James Nicholson, DM, MA, MRCPCH | Cambridge University Hospitals NHS Foundation Trust | Study Chair |
| Marie C. Baranzelli, MD | Centre Oscar Lambret | |
| U. Gobel, MD | Heinrich-Heine University, Duesseldorf |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Our Lady's Hospital for Sick Children | Dublin | 12 | Ireland | |||
| Birmingham Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33633029 | Derived | Rajagopal R, Leong SH, Jawin V, Foo JC, Ahmad Bahuri NF, Mun KS, Azman RR, Loh J, Yap TY, Ariffin H, Moreira DC, Gottardo NG, Bouffet E, Ganesan D. Challenges in the Management of Childhood Intracranial Germ Cell Tumors in Middle-Income Countries: A 20-Year Retrospective Review From a Single Tertiary Center in Malaysia. J Pediatr Hematol Oncol. 2021 Oct 1;43(7):e913-e923. doi: 10.1097/MPH.0000000000002116. |
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| Radiation |
| Birmingham |
| England |
| B4 6NH |
| United Kingdom |
| Institute of Child Health at University of Bristol | Bristol | England | BS2 8AE | United Kingdom |
| Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust | Cambridge | England | CB2 2QQ | United Kingdom |
| Leeds Cancer Centre at St. James's University 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 |
| Royal London Hospital | London | England | E1 1BB | United Kingdom |
| Great Ormond Street Hospital for Children NHS Trust | London | England | WC1N 3JH | United Kingdom |
| Central Manchester and Manchester Children's University Hospitals NHS Trust | Manchester | England | M27 4HA | United Kingdom |
| Sir James Spence Institute of Child Health | Newcastle upon Tyne | England | NE1 4LP | 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 NHS Foundation Trust - Surrey | Sutton | England | SM2 5PT | United Kingdom |
| Royal Belfast Hospital for Sick Children | Belfast | Northern Ireland | BT12 6BE | United Kingdom |
| Royal Aberdeen Children's Hospital | Aberdeen | Scotland | AB25 2ZG | United Kingdom |
| Royal Hospital for Sick Children | Edinburgh | Scotland | EH9 1LF | United Kingdom |
| Royal Hospital for Sick Children | Glasgow | Scotland | G3 8SJ | United Kingdom |
| Childrens Hospital for Wales | Cardiff | Wales | CF14 4XW | 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 |
|---|---|
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| C061400 | etoposide phosphate |
| D007069 | Ifosfamide |
| D017024 | Chemotherapy, Adjuvant |
| D020360 | Neoadjuvant Therapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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