Combination Chemotherapy and Radiation Therapy in Treating Patients With Germ Cell Tumors in the Brain
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|ClinicalTrials.gov Identifier: NCT00293358|
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : September 17, 2013
|First Submitted Date ICMJE||February 16, 2006|
|First Posted Date ICMJE||February 17, 2006|
|Last Update Posted Date||September 17, 2013|
|Study Start Date ICMJE||January 1997|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Not Provided|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Combination Chemotherapy and Radiation Therapy in Treating Patients With Germ Cell Tumors in the Brain|
|Official Title ICMJE||SIOP Intracranial Germ Cell Tumours Protocol|
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.
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 3|
|Study Design ICMJE||Allocation: Non-Randomized
Primary Purpose: Treatment
|Condition ICMJE||Brain and Central Nervous System Tumors|
|Study Arms ICMJE||Not Provided|
|Publications *||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.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE
|Original Enrollment ICMJE||Not Provided|
|Actual Study Completion Date ICMJE||December 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages ICMJE||Child, Adult, Older Adult|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Ireland, United Kingdom|
|Removed Location Countries|
|NCT Number ICMJE||NCT00293358|
|Other Study ID Numbers ICMJE||CDR0000455625
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Current Responsible Party||Not Provided|
|Original Responsible Party||Same as current|
|Current Study Sponsor ICMJE||Children's Cancer and Leukaemia Group|
|Original Study Sponsor ICMJE||United Kingdom Children's Cancer Study Group|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||July 2008|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP