NCT00047320|CompletedPhase 2ResultsDMC

Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors

A Phase II Study To Assess The Ability Of Neoadjuvant Chemotherapy Plus/Minus Second Look Surgery To Eliminate All Measurable Disease Prior To Radiotherapy For NGGCT

Children's Oncology Group ClinicalTrials.gov

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3 other identifiers

ACNS0122CDR0000257664COG-ACNS0122

Study Type

interventional

Target

104

Locations

5 countries

Sites

106

Timeline

RegisteredJan 2003

StartedJan 2004

CompletionFeb 2009

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it is no longer present by conventional imaging and tumor markers from serum and cerebrospinal fluid. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Combining different types of therapy may kill more tumor cells. PURPOSE: This Phase II trial is studying how well neoadjuvant chemotherapy with or without surgery and with or without high dose chemotherapy and peripheral stem cell transplantation, can increase response rates prior to radiation therapy and increase progression free and overall surviving patients with newly diagnosed intracranial germ cell tumors.

Trial Health

On Track

Trial Health Score

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

Enrollment

104

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Jan 2004

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

5.1 years study duration

First Submitted

Initial submission to the registry

October 3, 2002

Completed

4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

11 months until next milestone

Study Start

First participant enrolled

January 1, 2004

Completed

5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed

5.1 years until next milestone

Results Posted

Study results publicly available

February 27, 2014

Completed

Last Updated

February 14, 2018

Status Verified

January 1, 2018

Enrollment Period

5.1 years

First QC Date

October 3, 2002

Results QC Date

January 15, 2014

Last Update Submit

January 17, 2018

Conditions

Brain Tumor Central Nervous System Tumors Childhood Germ Cell Tumor

Keywords

childhood central nervous system germ cell tumorchildhood teratomarecurrent childhood malignant germ cell tumorchildhood central nervous system choriocarcinomachildhood central nervous system embryonal tumorchildhood central nervous system germinomachildhood central nervous system mixed germ cell tumorchildhood central nervous system teratomachildhood central nervous system yolk sac tumorrecurrent childhood central nervous system embryonal tumor

Outcome Measures

Primary Outcomes (1)

Response to Induction Chemotherapy
A patient who achieves a complete or partial response, defined a reduction of at least 65% in tumor size after induction chemotherapy will be considered to have experienced response.
18 weeks

Secondary Outcomes (5)

The Probability of Event-free Survival (EFS)
At 3 years from study entry
Progression-free Survival (PFS)
At 3 years from study entry
Overall Survival (OS)
At 3 years from study entry
Number of Patients Experiencing Toxic Death
During chemotherapy (up to 18 weeks)
Occurrence of Non-hematological Grade 4 Toxicity Occurrence of Nonhematological Grade 4 Toxicity
During chemotherapy(up to 18 weeks)

Study Arms (1)

Radiation Therapy (CR from Induction)

EXPERIMENTAL

Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC \> 750/L and platelets \> 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.

Drug: carboplatinDrug: etoposideDrug: ifosfamideDrug: thiotepaProcedure: adjuvant therapyProcedure: conventional surgeryProcedure: neoadjuvant therapyProcedure: peripheral blood stem cell transplantationRadiation: radiation therapy