The aim of the study is to assess if a dose reduction of craniospinal irradiation in children with a medulloblastoma does not reduce event free survival (EFS) or overall survival (OS). Furthermore it will be assessed if a field reduction (only tumor…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Efs and OS
Secondary outcome
Type of relapse
Cognitive, audiological and endocrinological outcome
Background summary
The treatment of children with a medulloblastoma with craniospinal irradiation
causes severe neurotoxicity. The tumor is sensitive to chemotherapy. Research
is needed to find the optimal combination of therapy.
Study objective
The aim of the study is to assess if a dose reduction of craniospinal
irradiation in children with a medulloblastoma does not reduce event free
survival (EFS) or overall survival (OS). Furthermore it will be assessed if a
field reduction (only tumor plus marging instead of the whole posterior fossa)
has effect on EFS en OS.
Study design
This is a multicentre, randomised, open, parallel-group phase III clinical
trial.
Intervention
Part 1: Chemo-radiotherapy
1. radiotherapy
Craniospinal irradiation will be given 5 times per week for a period of 6 weeks
Randomisation will determine if the patient receives 18,00 or 23,4 Gy. All
patients receive 54 Gy in the tumor region. A second randomisation will
determine if only the tumor + margin will be irradiated or the whole posterior
fossa
2. chemotherapy
vincristin (bolus, i.v.) will be given once a week for a period of 6 weeks,
starting in week 1 (1 week after start of irradiation)
Part 2: maintenance therapy
During this part of treatment only chemotherapy is given. De treatment is the
same in all patients. Approximately 4 weeks after finishing the
chemoradiotherapy phase, maintenance therapy wil be started.
The maintenance therapy consists of 9 courses. There are 2 different types of
courses, called A and B. After 2 A courses follows a B course, which totals up
to 6 A courses and 3 B courses.
Course A 42 days
CCNU (orally) day 1
Vincristin (bolus, i.v.) on day 1,8 en 15
Cisplatinum (i.v. drip) day 1
Course B 28 days
Cyclofosfamide (i.v. drip) day 1 en 2
Vincristin (bolus, i.v.) op day 1 en 8
Study burden and risks
The risks and burden of participation are similar to standard treatment. A
potential benefit is les side effects of treatment. Potential risk is an
increased chance of recurrence, although this is unlikely based on literature
data available.
Leyweg 299
2524 CJ Den Haag
NL
Leyweg 299
2524 CJ Den Haag
NL
Listed location countries
Age
Inclusion criteria
1) maximal cross-sectional area of residual tumor of 1.5 cm2 or less
2) no evidence of metastatic disease in the head, spine or CSF
3) performance level >/ 50% (Karnofsky/Lansky)
4)no previous radiotherapy or chemotherapy other than corticosteroids
5) adequate renal function
6) adequate liver function
7) adequate bone marrow function
8) no pregnancy/breast feeding
9) signed informed consent
10) national and institutional requirements for human studies must be met
Exclusion criteria
1) maximal cross-sectional area of residual tumor larger than 1.5 cm2
2) evidence of metastatic disease in the head, spine or CSF
3) performance level below 50% (Karnofsky/Lansky)
4) previous radiotherapy or chemotherapy
5) inadequate renal function
6) inadequate liver function
7) inadequate bone marrow function
8) pregnancy/breast feeding
9) no signed informed consent
10) national and institutional requirements for human studies are not met
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-010004-28-NL |
| CCMO | NL23774.078.09 |