Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003771

Trial Description

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Title

Cooperative Multicenter Study for Children and Adolescents With Low Grade Glioma

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Trial Acronym

SIOP-LGG-2004

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00003771
  •   2012/05/04
  •   2006/01/12
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   2005-005377-29 
  •   NCT00276640  (ClinicalTrials.gov)
  •   CDR0000454506  (Societe Internationale d'Oncologie Pediatrique)
  •   2005-005377-29 
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Health Condition or Problem studied

  •   Brain and Central Nervous System Tumors
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Interventions/Observational Groups

  •   Drug: vincristine, carboplatin
  •   Drug: vincristine, carboplatin, etoposide
  •   Radiation: radiation therapy
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group), Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

- Progression-free survival; time frame: week 24, and at 1, 3, and 5 years
- Event-free survival; time frame: week 24 and at 1, 3, and 5 years
- Overall survival; time frame: week 24 and at 1, 3, and 5 years

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Secondary Outcome

- Response week 24; time frame: week 24; radiological response to therapy (chemotherapy or radiation therapy)

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Countries of Recruitment

  •   Austria
  •   Belgium
  •   Croatia
  •   Denmark
  •   France
  •   Germany
  •   Italy
  •   Norway
  •   Poland
  •   Portugal
  •   Switzerland
  •   United Kingdom
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Locations of Recruitment

  •  
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Recruitment

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  •   2004/04/30
  •   3000
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   18   Years
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Additional Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed low-grade glioma, of 1 of the following histologic subtypes:

- Pilocytic astrocytoma I° and variants

- Subependymal giant cell astrocytoma I°

- Dysembryoplastic neuroepithelial tumor I°

- Desmoplastic infantile ganglioglioma I°

- Ganglioglioma I° and II°

- Pleomorphic xanthoastrocytoma II°

- Oligodendroglioma II°

- Oligoastrocytoma II°

- Astrocytoma II°

- Fibrillary astrocytoma II°

- Protoplasmatic astrocytoma II°

- Gemistocytic astrocytoma II°

- Children with chiasmatic-hypothalamic tumors may be eligible without histological
diagnosis, if neuroradiologic findings meet unequivocal criteria for the presence of
a low-grade glioma

- Primary tumor localization: intracranial and/or spinal cord

- No diffuse intrinsic tumors of the pons, even if histologically an astrocytoma
I° or II° is diagnosed

- Exception: pontine glioma II° in neurofibromatosis type 1 (NF1) disease
allowed

- Children presenting with disseminated low-grade glioma will be eligible for the study

- All eligible patients without NF1 disease receiving chemotherapy as their first
nonsurgical therapy are eligible for randomization

- Children are eligible for the trial regardless of the presence of associated genetic
disease: NF1 disease will be the prominent one, all children with NF1 disease are
entered into the study arm III in case of an indication for nonsurgical therapy

- Patients presenting with rare intracranial neoplasms of low-grade malignancy, but
nonglial origin, may be followed according to the low-grade glioma strategy, but they
are not subject of this therapy trial.

- Data from these patients may be registered to learn about those therapeutic
interventions which may prove useful to these patients and to develop separate
strategies in the future

- Patients with choroid plexus papilloma should be entered into the SIOP-CPT study
(Prof. Dr. J. Wolff, M.D. Anderson Cancer Center, Houston, Texas)

PATIENT CHARACTERISTICS:

- No preexisting impairments of health status, making the conduct of the study
impossible or ethically unwise

- No evidence of pregnancy or lactation period

- Pregnancy has to be prevented in fertile adolescent girls during chemotherapy by
reliable contraception methods (e.g., hormonal contraception)

PRIOR CONCURRENT THERAPY:

- The tumor should not be pretreated with chemotherapy or radiotherapy

- Children treated with chemotherapy or radiotherapy prior to entering the study
will be evaluated separately

- Previous treatment with steroids is not considered a chemotherapeutic
treatment

- Surgery of any type and extent allowed

- Prior surgical resection of the tumor allowed

- Participation in another clinical study concurrently with this study (e.g.,
endocrinologic study) allowed provided it is not interfering with the present
treatment strategy

- No other concurrent chemotherapy

- Concurrent medication for associated or other conditions (e.g., hormone replacement,
anticonvulsants) that does not containing cytostatic drugs allowed

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Exclusion Criteria

[---]*

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Societe Internationale d'Oncologie Pediatrique
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    •   [---]*
    •   [---]*
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  • start of 1:1-Block address scientific-contact
    • Klinikum Augsburg
    • Astrid Gnekow 
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    • Klinikum Augsburg
    • Astrid Gnekow 
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    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   8
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.