Radiation Therapy or Combination Chemotherapy in Treating Patients With Clinically or Radiologically Progressive Low-Grade Gliomas
- Conditions
- Primary Central Nervous System Neoplasms
- Interventions
- Registration Number
- NCT00276640
- Lead Sponsor
- Societe Internationale d'Oncologie Pediatrique
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This clinical trial is studying giving radiation therapy or combination chemotherapy to see how well it works in treating patients with clinically or radiologically progressive low-grade gliomas.
- Detailed Description
OBJECTIVES:
* Provide a comprehensive treatment strategy for children and adolescents with low-grade glioma of all tumour locations and histologies.
* Provide standardized treatment indication and treatment recommendations for non-surgical therapy in children and adolescents with low grade glioma without and with associated neurofibrosis-type 1 (NF1) at diagnosis or after observation.
* Determine overall, event-free, and progression-free survival.
* Radiotherapy arm: a. Determine progression free survival in older children without NF1 treated with radiotherapy using modern techniques for planning and treatment. b. Determine the reduction of the rate and intensity of possible late effects of therapy to the organs at risk by optimized planning and treatment.
* Chemotherapy arm: a. Determine progression free survival for younger children without NF1 treated with chemotherapy and randomized to either the 2-drug or the 3-drug induction regimen. b. Determine the distribution of response at week 24 (after induction) for younger children without NF1 treated with chemotherapy and randomized to either the 2-drug or the 3-drug induction regimen. c. Determine progression free survival for children with NF1treated with chemotherapy.
* Determine the influence of clinical and histological findings on overall survival, progression-free and event-free survival in these patients.
* Determine prospectively the late effects of tumor and therapy in these patients.
OUTLINE: This is a partially randomized, open-label, multicenter study.
Children with completely resected tumors, incompletely resected tumors, or those with clinically/neuroradiologically diagnosed tumors, who do not have severe symptoms at diagnosis, are only observed during follow-up.
Children with unresectable/incompletely-resectable tumors, or those with relapsed disease and those observed following incomplete initial resection or neuroradiologic diagnosis and clinical and/or neuro-radiologic progression receive non-surgical therapy. This non-surgical therapy is either chemotherapy (for children younger than 8 years and those with neurofibrosis-type 1 \[NF1\]) or radiotherapy (for children older than 8 years).
* Chemotherapy: Within the chemotherapy arm, patients without NF1 are randomized to receive 1 of 2 induction chemotherapy regimens. Patients with NF1 receive the two-drug induction therapy as in arm I.
* Arm I (two-drug induction therapy \[vincristine-carboplatin\] ): Patients receive induction therapy comprising vincristine IV on day 1 of weeks 1-10 and weeks 13, 17, and 21 and carboplatin IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 17, and 21.
* Arm II (three-drug induction therapy \[vincristine-carboplatin-etoposide\]): Patients receive vincristine and carboplatin as in two-drug induction therapy. Patients also receive etoposide IV over 1 hour on days 1-3 of weeks 1, 4, 7, and 10.
Beginning in week 25, all patients in the chemotherapy arm receive consolidation therapy comprising vincristine IV on days 1, 8, and 15 and carboplatin IV over 1 hour on day 1. Treatment repeats every 6 weeks for 9 courses. Patients experiencing disease progression or an allergic reaction to carboplatin receive vincristine IV on days 1, 8, and 15 and either cyclophosphamide IV over 1 hour on day 1 or cisplatin IV over 3 hours on days 1 and 2. Treatment repeats every 6 weeks for 5 courses. All patients in the chemotherapy arm receive a total of 18 months of treatment.
* Radiotherapy: Conventional external beam fractionated radiotherapy is given at standard doses for children receiving radiotherapy. Brachytherapy can be given, if tumors are suitable for this type of treatment.
After completion of study treatment, patients are followed periodically for 10 years.
PROJECTED ACCRUAL: A total of 520 patients will be accrued for the randomized arm of this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3417
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description radiation radiation therapy radiation therapy group vincristine, carboplatin vincristine, carboplatin standard chemotherapy group vincristine, carboplatin, etoposide vincristine, carboplatin, etoposide intensified induction chemotherapy group
- Primary Outcome Measures
Name Time Method Overall survival week 24 and at 1, 3, and 5 years Progression-free survival week 24, and at 1, 3, and 5 years Event-free survival week 24 and at 1, 3, and 5 years
- Secondary Outcome Measures
Name Time Method Response week 24 week 24 radiological response to therapy (chemotherapy or radiation therapy)
Trial Locations
- Locations (13)
Institut Gustave Roussy
🇫🇷Villejuif, France
Aalborg Hospital
🇩🇰Aalborg, Denmark
Klinikum Augsburg
🇩🇪Augsburg, Germany
University of Tromso
🇳🇴Tromso, Norway
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
🇦🇹Wien, Austria
Universitair Ziekenhuis Gent
🇧🇪Ghent, Belgium
Children's Hospital Zagreb
ðŸ‡ðŸ‡·Zagreb, Croatia
Children's Memorial Health Institute
🇵🇱Warsaw, Poland
Hospital San Joao
🇵🇹Porto, Portugal
University Children's Hospital
🇨ðŸ‡Zurich, Switzerland
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Queen's Medical Centre
🇬🇧Nottingham, England, United Kingdom