NCT00003573|CompletedPhase 2DMC

Etoposide Plus Radiation Therapy Followed by Combination Chemotherapy in Treating Children With Newly Diagnosed Advanced Medulloblastoma

A Phase I/II Feasibility Study of Oral Etoposide Given Concurrently With Radiotherapy Followed With Dose Intensive Adjuvant Chemotherapy for Children With Newly Diagnosed High Stage Medulloblastoma

Children's Oncology Group ClinicalTrials.gov

Compare

3 other identifiers

9631POG-9631CDR0000066640

Study Type

interventional

Target

Locations

5 countries

Sites

106

Timeline

RegisteredFeb 2004

StartedNov 1998

CompletionMar 2008

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of etoposide plus radiation therapy followed by combination chemotherapy in treating children with newly diagnosed advanced medulloblastoma.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Nov 1998

Longer than P75 for phase_2

Geographic Reach

5 countries

106 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.3 years study duration

Study Start

First participant enrolled

November 1, 1998

Completed

1 year until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed

4.3 years until next milestone

First Posted

Study publicly available on registry

February 20, 2004

Completed

3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed

Last Updated

July 25, 2014

Status Verified

July 1, 2014

Enrollment Period

8.9 years

First QC Date

November 1, 1999

Last Update Submit

July 24, 2014

Conditions

Brain Tumors Central Nervous System Tumors

Keywords

untreated childhood medulloblastoma

Outcome Measures

Primary Outcomes (1)

Assess the efficacy of oral etoposide at 50 mg/m2/day given concurrently with radiotherapy followed with dose intensive adjuvant chemotherapy in children with newly diagnosed high stage medulloblastoma
It is possible that unacceptably high levels of toxicity may arise. For this reason, there is a 3-stage stopping rule designed to allow the Study Coordinator to stop this study early if it appears that the true proportion of eligible patients who suffer unacceptable levels of toxicity exceeds 10%.
End of course 1 (week 10)

Study Arms (2)

Treatment 1, Etoposide, 50mg/m2/day

EXPERIMENTAL

Patients begin treatment within 1 month of surgery. Patients receive 6 weeks of radiation therapy to the head and spine, with boosts to the posterior fossa and to sites of metastasis. Patients also receive 2 courses of oral etoposide once daily for 3 weeks concurrent with and immediately following radiotherapy (weeks 1-3 and 5-7). Patients then receive adjuvant chemotherapy consisting of cisplatin IV once every 4 weeks for 3 courses beginning on week 11, oral etoposide daily for 21 days every 4 weeks for 3 courses (weeks 11, 15, and 19), cyclophosphamide IV on days 1 and 2 with filgrastim (G-CSF) SQ daily for at least 10 days every 4 weeks for 8 courses (weeks 23-51), and vincristine IV on days 1, 8, and 15 every 4 weeks for 8 courses (weeks 23-51).

Biological: filgrastimDrug: cisplatinDrug: cyclophosphamideDrug: etoposideDrug: vincristine sulfateRadiation: radiation therapy

Treatment 2, Etoposide, 35mg/m2/day

EXPERIMENTAL

Biological: filgrastimDrug: cisplatinDrug: cyclophosphamideDrug: etoposideDrug: vincristine sulfateRadiation: radiation therapy