NCT01602666|CompletedPhase 2ResultsDMC

Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors

Phase 2 Trial of Response-Based Radiation Therapy for Patients With Localized Central Nervous System Germ Cell Tumors (CNS GCT)

Children's Oncology Group ClinicalTrials.gov

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7 other identifiers

ACNS1123NCI-2012-01967CDR0000734032S12-02807K12CA086913U10CA098543U10CA180886

Study Type

interventional

Target

262

Locations

5 countries

Sites

167

Timeline

RegisteredMay 2012

StartedJun 2012

CompletionSep 2024

Brief Summary

This phase II trial studies how well chemotherapy followed by radiation therapy work in treating younger patients with newly diagnosed central nervous system germ cell tumors that have not spread to other parts of the brain, spinal canal, or body (localized). Drugs used as chemotherapy, such as carboplatin, etoposide, and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x rays to kill tumor cells. Giving chemotherapy followed by radiation therapy may kill more tumor cells.

Trial Health

On Track

Trial Health Score

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

Enrollment

262

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jun 2012

Longer than P75 for phase_2

Geographic Reach

5 countries

167 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

12.3 years study duration

First Submitted

Initial submission to the registry

May 18, 2012

Completed

3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2012

Completed

1 month until next milestone

Study Start

First participant enrolled

June 27, 2012

Completed

8.5 years until next milestone

Results Posted

Study results publicly available

December 16, 2020

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

12.3 years

First QC Date

May 18, 2012

Results QC Date

September 30, 2020

Last Update Submit

November 7, 2025

Conditions

Central Nervous System Nongerminomatous Germ Cell Tumor Childhood Germinoma

Outcome Measures

Primary Outcomes (3)

3-year Progression-free Survival (PFS) Rate of Patients With Nongerminomatous Germ Cell Tumor (NGGCT) Who Were Treated With Reduced Dose Whole Ventricular-field Irradiation
Binomial estimate of the 3-year PFS rate defined as "Yes" for patients who were followed up per protocol and were progression free at 3-years, and "No" for those who either experienced a progression or were lost to follow-up/withdrew from the trial within 3 years from enrollment. Progression was determined by MRI using the COG Guidelines for Measurement of Tumor Size (\>25% increase in 2D or \>40% in 3D of the product of perpendicular diameters of the target lesion) as well as by tumor marker assessments which were mandatory for this study.
3 years
3-year PFS Rate of Patients With Localized CNS Germinoma Who Were Treated With Reduced Dose Radiation Therapy
Binomial estimate of the 3-year PFS rate defined as "Yes" for patients who were followed up per protocol and were progression free at 3-years, and "No" for those who either experienced a progression or were lost to follow-up/withdrew from the trial within 3 years from initiation of treatment. Progression was determined by MRI using the COG Guidelines for Measurement of Tumor Size (\>25% increase in 2D or \>40% in 3D of the product of perpendicular diameters of the target lesion) as well as by tumor marker assessments which were mandatory for this study.
3 years
Neurocognitive Function Using the ALTE07C1 Protocol
Estimated scores for the cognitive functions of processing speed, attention/concentration, and estimated IQ were assessed using the age-appropriate version of the Wechsler Scales of Intelligence. The range for the Processing Speed Index (PSI) is 45 to 155, with a mean of 100 and a standard deviation of 15. Estimated IQ was estimated using 2 subtests from the Wechsler Scales of Intelligence to derive a standard score with a mean of 100 and standard deviation of 15 with a range of 45 to 158. Scores from the 2 subtests were summed and translated to a standard score using published procedures. Attention/concentration was measured by the Digit Span subtest score from the Wechsler Scales of Intelligence. Subset scores have a range of 1-19, with a mean of 10 and standard deviation of 3. Higher scores on all these measures indicate higher or better cognitive performance, lower scores indicate lower or worse cognitive functioning.
Up to 5 years

Secondary Outcomes (4)

Estimation of the PFS Distribution of Patients With NGGCT Treated With Involved-field Radiation Therapy (IFR)
Up to 3 years
Estimation of the Overall Survival (OS) Distribution of Patients With NGGCT Treated With IFR Assessed
Up to 3 years
Estimation of the PFS Distribution of Patients With Localized Germinoma Patients and Cerebrospinal Fluid (CSF) Serum hCGbeta of 50 mIU/mL or Less or CSF Serum hCGbeta Greater Than 50 mIU/mL and Less Than or Equal to 100 mIU/mL
Up to 3 years
Estimation of the OS Distribution of Patients With Localized Germinoma Patients and CSF Serum hCGbeta of 50 mIU/mL or Less or CSF Serum hCGbeta Greater Than 50 mIU/mL and Less Than or Equal to 100 mIU/mL
Up to 3 years

Study Arms (1)

Treatment (combination chemotherapy, radiation therapy)

EXPERIMENTAL

See Detailed Description

Radiation: 3-Dimensional Conformal Radiation TherapyDrug: CarboplatinDrug: EtoposideDrug: IfosfamideRadiation: Intensity-Modulated Radiation Therapy

Interventions

3-Dimensional Conformal Radiation TherapyRADIATION

Undergo 3D-CRT

Also known as: 3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D radiotherapy, 3D-CRT, Conformal Therapy, Radiation Conformal Therapy, Radiation, 3D Conformal, Three dimensional external beam radiation therapy (procedure)