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Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma

23 juin 2014 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Tumeurs du cerveau et du système nerveux central

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

316

Phase

Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Allemagne
- - Wuerzburg, Allemagne, D-97080
    - Universitaets - Kinderklinik Wuerzburg
Belgique
- - Leuven, Belgique, B-3000
    - U.Z. Gasthuisberg
Espagne
- - Vizcaya, Espagne, 48
    - Hospital De Cruces
France
- - Paris, France, 75248
    - Institut Curie Hopital
Italie
- - Turin, Italie, 10126
    - Ospedale Infantile Regina Margherita
Pays-Bas
- - Amsterdam, Pays-Bas, 1105 AZ
    - Academisch Medisch Centrum at University of Amsterdam
Royaume-Uni
- England
  - Liverpool, England, Royaume-Uni, L12 2AP
    - Royal Liverpool Children's Hospital, Alder Hey
Suède
- - Gothenburg, Suède, 41685
    - Ostra Sjukhuset

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

3 ans à 21 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Objectif principal: Traitement
Répartition: Randomisé

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Comparison of event-free survival at 3 years

Mesures de résultats secondaires

Mesure des résultats
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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Leicester

Les enquêteurs

Chaise d'étude: Brigitta Lannering, MD, PhD, Ostra Sjukhuset

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 février 2003

Dates d'inscription aux études

Première soumission

5 février 2003

Première soumission répondant aux critères de contrôle qualité