Radiation Therapy or Combination Chemotherapy in Treating Patients With Clinically or Radiologically Progressive Low-Grade Gliomas

NCT00276640 | Completed DMC

• 2 other identifiers: CDR00004545062005-005377-29
• Study Type: interventional
• Target: 3,417
• Locations: 12 countries
• Sites: 13

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.

Conditions

Primary Central Nervous System Neoplasms

Keywords

recurrent childhood brain stem glioma; untreated childhood brain stem glioma; recurrent childhood cerebellar astrocytoma; untreated childhood cerebellar astrocytoma; childhood low-grade cerebral astrocytoma; recurrent childhood cerebral astrocytoma; childhood oligodendroglioma; recurrent childhood visual pathway and hypothalamic glioma; untreated childhood visual pathway and hypothalamic glioma; childhood spinal cord neoplasm

Outcome Measures

Primary Outcomes (3)

• Progression-free survival

  week 24, and at 1, 3, and 5 years

• Event-free survival

  week 24 and at 1, 3, and 5 years

• Overall survival

  week 24 and at 1, 3, and 5 years

Secondary Outcomes (1)

• Response week 24

  week 24

Study Arms (4)

vincristine, carboplatin

ACTIVE COMPARATOR

standard chemotherapy group

Drug: vincristine, carboplatin

vincristine, carboplatin, etoposide

ACTIVE COMPARATOR

intensified induction chemotherapy group

Drug: vincristine, carboplatin, etoposide

radiation

ACTIVE COMPARATOR

radiation therapy group

Radiation: radiation therapy

Control

NO INTERVENTION

Control group: wait and see strategy

Interventions

vincristine, carboplatin DRUG

vincristine: 1,5 mg/m² i.v., week 1,2,3,4,5,6,7,8,9,10,13,17,21 carboplatin: 550 mg/m² i.v., week 1,4,7,10,13,17,21

vincristine, carboplatin

vincristine, carboplatin, etoposide DRUG

vincristine: 1,5 mg/m² i.v., week 1,2,3,4,5,6,7,8,9,10,13,17,21 carboplatin: 550 mg/m² i.v., week 1,4,7,10,13,17,21 etoposide: 100 mg/m² i.v., week 1,4,7,10

vincristine, carboplatin, etoposide

radiation therapy RADIATION

intracranial tumor site: 30 fractions, dose per fraction: 1.8 Gy, total dose: 54 Gy, duration 6 weeks spinal tumor site: 28 fractions, dose per fraction: 1.8 Gy, total dose: 50.4 Gy duration 5 1/2 weeks

radiation

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: children and adolescents up to the completion of the 18th year of life.
• Histology: low grade glioma according to ICD O Code 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.
• Dissemination: Children presenting with disseminated low grade glioma will be eligible for the study.
• Associated conditions: Children are eligible for the trial regardless of the presence of associated genetic disease: Neurofibromatosis NF I will be the prominent one, all children with NF I are entered into the study arm III in case of an indication for non-surgical therapy. Other conditions like Tuberous Sclerosis etc. should be registered and their impact on the course of disease and/or therapy be followed.
• Primary tumor diagnosis: The tumor should not be pretreated with chemotherapy or radiotherapy.
• Informed consent: The patient and/or his legal guardian ( parents ) have to have declared their written informed consent to the study.
• Randomization: All eligible patients without Neurofibromatosis NF I receiving chemotherapy as their fist non-surgical therapy are eligible for randomization.

You may not qualify if:

• Primary tumor localization: diffuse intrinsic tumors of the pons, even if histologically an Astrocytoma I° or II° is diagnosed.
• Exception: pontine glioma II° in NF I patients may be entered into the study.
• Special diagnosis: Patients presenting with rare intracranial neoplasms of low grade malignancy, but non-glial origin may be followed according to the low grade glioma strategy but they are not subject of this therapy trial. Their data may be registered however, to learn about those therapeutic interventions which may prove useful to these patients and to develop separate strategies in the future. Choroid plexus papilloma should be entered into the SIOP-CPT study.
• Pretreatment: Children treated with chemo- or radiotherapy prior to entering the study will be evaluated separately. (Previous treatment with steroids is not considered a chemotherapeutic treatment.)
• Preexisting impairments of health status, making the conduct of the study impossible or ethically unwise.
• Evidence of pregnancy or lactation period.
• Participation in another clinical study: In case the patient participates in another clinical study simultaneously to being enrolled in the study SIOP-LGG 2004, which is not interfering with the present treatment strategy ( e.g. endocrinologic study ), this should be known to the national study chairmen.

Sponsors & Collaborators

• Societe Internationale d'Oncologie Pediatrique: lead

Study Sites (13)

Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik

Vienna, 1090, Austria

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

Children's Hospital Zagreb

Zagreb, 10000, Croatia

Location

Aalborg Hospital

Aalborg, 9100, Denmark

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Klinikum Augsburg

Augsburg, DOH-86156, Germany

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

University of Tromso

Tromsø, N-9037, Norway

Location

Children's Memorial Health Institute

Warsaw, 04-736, Poland

Location

Hospital San Joao

Porto, 4200, Portugal

Location

University Children's Hospital

Zurich, CH-8032, Switzerland

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Related Publications (3)

• Gnekow AK, Walker DA, Kandels D, Picton S, Giorgio Perilongo, Grill J, Stokland T, Sandstrom PE, Warmuth-Metz M, Pietsch T, Giangaspero F, Schmidt R, Faldum A, Kilmartin D, De Paoli A, De Salvo GL; of the Low Grade Glioma Consortium and the participating centers. A European randomised controlled trial of the addition of etoposide to standard vincristine and carboplatin induction as part of an 18-month treatment programme for childhood (</=16 years) low grade glioma - A final report. Eur J Cancer. 2017 Aug;81:206-225. doi: 10.1016/j.ejca.2017.04.019. Epub 2017 Jun 22.

  PMID: 28649001 RESULT

• Weiss S, Thomale UW, Schulz M, Kandels D, Schuhmann MU, El Damaty A, Krauss J, Driever PH, Witt O, Bison B, Pietsch T, Gnekow A, Simon M. Neurosurgical morbidity in pediatric supratentorial midline low-grade glioma: Results from the German LGG studies. Int J Cancer. 2023 Oct 15;153(8):1487-1500. doi: 10.1002/ijc.34615. Epub 2023 Jun 1.

  PMID: 37260252 DERIVED

• Kandels D, Pietsch T, Bison B, Warmuth-Metz M, Thomale UW, Kortmann RD, Timmermann B, Hernaiz Driever P, Witt O, Schmidt R, Gnekow AK. Loss of efficacy of subsequent nonsurgical therapy after primary treatment failure in pediatric low-grade glioma patients-Report from the German SIOP-LGG 2004 cohort. Int J Cancer. 2020 Dec 15;147(12):3471-3489. doi: 10.1002/ijc.33170. Epub 2020 Jul 11.

  PMID: 32580249 DERIVED

MeSH Terms

Conditions

Central Nervous System Neoplasms; Astrocytoma; Oligodendroglioma; Optic Nerve Glioma; Spinal Cord Neoplasms

Interventions

Vincristine; Carboplatin; Etoposide; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Optic Nerve Diseases; Eye Diseases; Spinal Cord Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Therapeutics

Study Officials

• Astrid Gnekow

  University Hospital Augsburg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairlady

Study Record Dates

• First Submitted: January 12, 2006
• First Posted: January 13, 2006
• Study Start: April 1, 2004
• Primary Completion: December 31, 2015
• Study Completion: May 31, 2017
• Last Updated: April 20, 2018

Record last verified: 2018-04

Locations

PL (1); BE (1); DE (1); CH (1); FR (1); CR (1); PT (1); AU (1); IT (1); NO (1); GB (2); DK (1)