Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma
A Prospective Randomised Controlled Trial Of Hyperfractionated Versus Conventionally Fractionated Radiotherapy In Standard Risk Medulloblastoma
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.
調査の概要
詳細な説明
OBJECTIVES:
- Compare the event-free survival rate in pediatric patients with standard-risk medulloblastoma treated with conventional vs hyperfractionated radiotherapy and vincristine followed by maintenance with cisplatin, lomustine, and vincristine.
- Compare the overall survival of patients treated with these regimens.
- Compare the pattern of relapse, especially local relapse (tumor bed or posterior fossa outside tumor bed), in patients treated with these regimens.
- Determine the toxicity of surgery and whether there are identifiable factors that correlate with toxicity in these patients.
- Determine the impact of any surgical complications on commencement of adjuvant therapy and event-free survival of these patients.
- Compare late sequelae, in terms of health status, endocrine deficiencies, and hearing loss, in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to country. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Within 28-40 days after surgical resection, patients undergo conventional fractionated radiotherapy once daily, 5 days a week, for 6-7 weeks. Patients also receive vincristine IV once weekly for 8 weeks.
- Arm II: Beginning as in arm I, patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, for 6-7 weeks. Patients also receive vincristine as in arm I.
- Maintenance chemotherapy:Six weeks after completion of radiotherapy, all patients receive cisplatin IV over 6 hours and oral lomustine on day 1 and vincristine IV on days 1, 8, and 15. Treatment repeats every 6 weeks for 8 courses.
Patients are followed at least every 6 months for 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 316 patients (158 per treatment arm) will be accrued for this study within 4 years.
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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England
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Liverpool、England、イギリス、L12 2AP
- Royal Liverpool Children's Hospital, Alder Hey
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Turin、イタリア、10126
- Ospedale Infantile Regina Margherita
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Amsterdam、オランダ、1105 AZ
- Academisch Medisch Centrum at University of Amsterdam
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Gothenburg、スウェーデン、41685
- Ostra Sjukhuset
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Vizcaya、スペイン、48
- Hospital De Cruces
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Wuerzburg、ドイツ、D-97080
- Universitaets - Kinderklinik Wuerzburg
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Paris、フランス、75248
- Institut Curie Hopital
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Leuven、ベルギー、B-3000
- U.Z. Gasthuisberg
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
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Comparison of event-free survival at 3 years
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二次結果の測定
結果測定 |
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Comparison of overall survival
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Comparison of the pattern of relapse (i.e., local relapse [tumor bed and posterior fossa outside tumor bed])
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Comparison of late sequelae, in terms of health status, quality of life, hearing loss, and endocrine deficiencies
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Toxicity of neurosurgery
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協力者と研究者
スポンサー
捜査官
- スタディチェア：Brigitta Lannering, MD, PhD、Ostra Sjukhuset
研究記録日
主要日程の研究
研究開始
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CDR0000269521
- SIOP-PNET-4
- EU-20244
- UKCCSG-CNS-2003-05
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