NCT00003203|CompletedPhase 2DMC

Carboplatin and Vincristine Plus Radiation Therapy Followed By Adjuvant Chemotherapy in Treating Young Patients With Newly Diagnosed CNS Embryonal Tumors

An Intergroup Pilot Study of Concurrent Carboplatin, Vincristine and Radiotherapy Followed by Adjuvant Chemotherapy in Patients With Newly Diagnosed High-Risk Central Nervous System Embryonal Tumors

Children's Oncology Group ClinicalTrials.gov

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4 other identifiers

A9971COG-A9971CCG-99701CDR0000066055

Study Type

interventional

Target

168

Locations

3 countries

Sites

Timeline

RegisteredMay 2003

StartedMar 1998

CompletionMar 2012

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and vincristine, work in 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 carboplatin and vincristine with radiation therapy followed by adjuvant chemotherapy may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy followed adjuvant chemotherapy in treating young patients who have newly diagnosed high-risk CNS embryonal tumors.

Trial Health

On Track

Trial Health Score

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

Enrollment

168

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Mar 1998

Longer than P75 for phase_2

Geographic Reach

3 countries

38 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

14 years study duration

Study Start

First participant enrolled

March 1, 1998

Completed

1.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed

3.5 years until next milestone

First Posted

Study publicly available on registry

May 19, 2003

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed

4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed

Last Updated

August 23, 2013

Status Verified

August 1, 2013

Enrollment Period

9.6 years

First QC Date

November 1, 1999

Last Update Submit

August 22, 2013

Conditions

Brain Tumors Central Nervous System Tumors Neuroblastoma

Keywords

untreated childhood supratentorial primitive neuroectodermal tumoruntreated childhood medulloblastomalocalized unresectable neuroblastomaregional neuroblastomastage 4S neuroblastoma

Outcome Measures

Primary Outcomes (1)

Event Free Survival
Minimum time to disease progression or recurrence, time to death for any reason, or time to occurrence of a second malignant neoplasm (SMN).
Length of study

Secondary Outcomes (1)

Survival
Length of study

Study Arms (1)

Newly diagnosed cerebral PNET with histologic verification

EXPERIMENTAL

Begin therapy within 31 days of surgery. Radiation therapy will be given in standard fractions along with filgrastim. The craniospinal axis will be treated first. Patients will receive carboplatin at 35 mg/m2/day IV over 15-20 minutes Monday through Friday, 1-4 hours prior to radiation for 6 weeks (total of 30 doses). Vincristine sulfate 1.5 mg/m2 IV will be given weekly x 6. Following radiation, patients will receive Maintenance chemotherapy. Patients enrolled prior to Amendment #5 will receive six cycles of cyclophosphamide and vincristine (Regimen A). Patients enrolled after Amendment #5 will receive six cycles of cyclophosphamide, vincristine sulfate and cisplatin (Regimen B).

Biological: filgrastimDrug: carboplatinDrug: cisplatinDrug: cyclophosphamideDrug: vincristine sulfateProcedure: adjuvant therapyRadiation: radiation therapy