NCT00085098|CompletedPhase 3ResultsDMC

Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Primary Central Nervous System (CNS) Germ Cell Tumor

Radiotherapy Alone Versus Chemotherapy Followed By Response-Based Radiotherapy For Newly Diagnosed Primary CNS Germinoma

Children's Oncology Group ClinicalTrials.gov

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3 other identifiers

ACNS0232CDR0000367294COG-ACNS0232

Study Type

interventional

Target

Locations

4 countries

Sites

107

Timeline

RegisteredJun 2004

StartedJan 2007

CompletionMay 2009

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy alone is as effective as chemotherapy plus radiation therapy in treating germ cell tumor. PURPOSE: This randomized phase III trial is studying radiation therapy alone to see how well it works compared to chemotherapy and radiation therapy in treating patients with newly diagnosed primary CNS germ cell tumor.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Jan 2007

Geographic Reach

4 countries

107 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

2.3 years study duration

First Submitted

Initial submission to the registry

June 10, 2004

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2004

Completed

2.6 years until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed

4.5 years until next milestone

Results Posted

Study results publicly available

November 6, 2013

Completed

Last Updated

September 7, 2018

Status Verified

August 1, 2018

Enrollment Period

2.3 years

First QC Date

June 10, 2004

Results QC Date

June 7, 2013

Last Update Submit

August 8, 2018

Conditions

Brain Tumor Central Nervous System Tumor

Keywords

childhood central nervous system germ cell tumor

Outcome Measures

Primary Outcomes (1)

Event-free Survival
Data will be summarized as number of patients in the following categories at the time of data cutoff for analyses of 3-year EFS: 1)Experienced a qualifying event (QE) (see below);2)Event-free through 3 years of follow-up;3)Event-free until data cutoff (if less than 3 years of follow-up);4)Withdrew from study;5)Lost to follow-up. QEs: 1)disease progression, defined as increase \>= 40% in tumor volume or \>= 25% in tumor area of target lesions;2)development of new lesions;3)occurrence of a second malignant neoplasm, defined as a malignancy with different histological type from trial-qualifying diagnosis;4)death from any cause. Stat. analyses will be based on time from enrollment to the earliest of: 1)occurrence of any of the QEs;2)withdrawal from study or lost to follow-up;3)completion of three years of follow-up event-free;4)data cutoff for completion of the statistical analyses for the protocol's primary objective. NOTE: Reported data are through May 2009 (see Caveats section).
Study enrollment until date of earliest qualifying event (QE), date last known to be QE-free if the patient is followed for less than three years and is QE-free at the time of analysis, or 3 years if the patient is QE-free at 3 years

Secondary Outcomes (3)

Number of Participants With a Response to Regimen B
5 years from beginning of treatment
Toxicity and Safety as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
From the beginning of treatment, assessed up to 5 years
Quality of Life (QOL) and Neurocognitive Assessment (NP)
2 years from beginning of treatment

Study Arms (2)

Regimen A (radiotherapy only)

EXPERIMENTAL

Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.

Radiation: radiation therapy

Regimen B (chemotherapy plus radiotherapy)

EXPERIMENTAL

Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses. Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below. Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF), subcutaneous (SC) or IV beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or progressive disease (PD) are restaged and may undergo standard radiation therapy as in regimen A. Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks

Biological: filgrastimDrug: carboplatinDrug: cisplatinDrug: cyclophosphamideDrug: etoposideRadiation: radiation therapy