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Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma

23. juni 2014 opdateret af: University of Leicester

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.

Studieoversigt

Status

Ukendt

Betingelser

Tumorer i hjernen og centralnervesystemet

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

316

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Belgien
- - Leuven, Belgien, B-3000
    - U.Z. Gasthuisberg
Det Forenede Kongerige
- England
  - Liverpool, England, Det Forenede Kongerige, L12 2AP
    - Royal Liverpool Children's Hospital, Alder Hey
Frankrig
- - Paris, Frankrig, 75248
    - Institut Curie Hopital
Holland
- - Amsterdam, Holland, 1105 AZ
    - Academisch Medisch Centrum at University of Amsterdam
Italien
- - Turin, Italien, 10126
    - Ospedale Infantile Regina Margherita
Spanien
- - Vizcaya, Spanien, 48
    - Hospital De Cruces
Sverige
- - Gothenburg, Sverige, 41685
    - Ostra Sjukhuset
Tyskland
- - Wuerzburg, Tyskland, D-97080
    - Universitaets - Kinderklinik Wuerzburg

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

3 år til 21 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Comparison of event-free survival at 3 years

Sekundære resultatmål

Resultatmål
Comparison of overall survival
Comparison of the pattern of relapse (i.e., local relapse [tumor bed and posterior fossa outside tumor bed])
Comparison of late sequelae, in terms of health status, quality of life, hearing loss, and endocrine deficiencies
Toxicity of neurosurgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Leicester

Efterforskere

Studiestol: Brigitta Lannering, MD, PhD, Ostra Sjukhuset

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2003

Datoer for studieregistrering

Først indsendt

5. februar 2003

Først indsendt, der opfyldte QC-kriterier