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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00047320
Registration number
NCT00047320
Ethics application status
Date submitted
3/10/2002
Date registered
27/01/2003
Date last updated
14/02/2018
Titles & IDs
Public title
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
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Scientific title
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
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Secondary ID [1]
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CDR0000257664
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Secondary ID [2]
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ACNS0122
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Brain Tumor
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Central Nervous System Tumors
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Childhood Germ Cell Tumor
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Condition category
Condition code
Cancer
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Ovarian and primary peritoneal
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Cancer
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Testicular
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Cancer
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Other cancer types
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Cancer
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Neuroendocrine tumour (NET)
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Cancer
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Brain
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Cancer
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Children's - Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - carboplatin
Treatment: Drugs - etoposide
Treatment: Drugs - ifosfamide
Treatment: Drugs - thiotepa
Treatment: Other - radiation therapy
Experimental: Radiation Therapy (CR from Induction) - 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.
Treatment: Drugs: carboplatin
Given IV
Treatment: Drugs: etoposide
Given IV
Treatment: Drugs: ifosfamide
Given IV
Treatment: Drugs: thiotepa
Given IV
Treatment: Other: radiation therapy
craniospinal irradiation
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Response to Induction Chemotherapy
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Assessment method [1]
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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.
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Timepoint [1]
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18 weeks
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Secondary outcome [1]
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The Probability of Event-free Survival (EFS)
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Assessment method [1]
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Event-free Survival was defined as time from study entry to death from any cause, disease progression or recurrence, or second malignant neoplasm. Event-free survival was estimated by KM estimate.
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Timepoint [1]
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At 3 years from study entry
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Secondary outcome [2]
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Progression-free Survival (PFS)
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Assessment method [2]
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Progression-free Survival was defined as time from study entry to disease progression or recurrence. Deaths that are clearly unrelated to disease progression, and second neoplasms are censored in this analysis. Progression -free survival was estimated by KM estimate.
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Timepoint [2]
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At 3 years from study entry
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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Overall Survival was defined as time from study entry to death from any cause. Overall survival was estimated by KM estimate.
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Timepoint [3]
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At 3 years from study entry
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Secondary outcome [4]
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Number of Patients Experiencing Toxic Death
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Assessment method [4]
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Toxic death, defined as death predominantly attributable to treatment-related causes.
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Timepoint [4]
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During chemotherapy (up to 18 weeks)
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Secondary outcome [5]
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Occurrence of Non-hematological Grade 4 Toxicity Occurrence of Nonhematological Grade 4 Toxicity
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Assessment method [5]
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The number of patients who experienced non-hematological grade 4 toxicities anytime during chemotherapy.
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Timepoint [5]
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During chemotherapy(up to 18 weeks)
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
* One of the following diagnoses:
* Histologically confirmed intracranial non-germinomatous germ cell tumor (NGGCT) of 1 of the following types:
* Endodermal sinus tumor (yolk sac tumor)
* Embryonal carcinoma
* Choriocarcinoma
* Immature teratoma and teratoma with malignant transformation
* Mixed germ cell tumor
* Histologically confirmed germinoma with elevation of serum/CSF beta human chorionic gonadotropin (HCG) levels greater than 50 mIU/mL or any serum/CSF alpha-fetoprotein (AFP) levels greater than 10 ng/ml or above institutional norm
* Histologically unconfirmed pineal and/or suprasellar tumors with serum/CSF beta HCG levels greater than 50 mIU/mL or AFP levels greater than 10 ng/ml or above institutional norm
* Patients with normal AFP and beta HCG < 50 mIU/mL without histologic diagnosis of a NGGCT or patients with pure germinoma without elevation of tumor marker are ineligible
* Initial diagnosis within the past 31 days
PATIENT CHARACTERISTICS:
Age
* 3 to 24 at diagnosis
Performance status
* No minimum performance level
Life expectancy
* At least 8 weeks
Hematopoietic
* Absolute neutrophil count at least 1,000/mm^3
* Platelet count at least 100,000/mm^3 (transfusion independent)
* Hemoglobin at least 10.0 g/dL (transfusion allowed)
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* ALT no greater than 2.5 times ULN
Renal
* Creatinine no greater than 1.5 times ULN OR
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
Pulmonary
* No assisted ventilation
Other
* Seizure disorders allowed
* No patients in status or coma
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patient must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Prior corticosteroids allowed
* Concurrent corticosteroids allowed
* Concurrent endocrine replacement therapy allowed (e.g., L-thyroxine, testosterone, estrogen, desmopressin acetate)
* No concurrent growth hormone therapy
Radiotherapy
* Not specified
Surgery
* More than 1 prior surgery allowed
Other
* No other prior therapy for malignancy
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Minimum age
3
Years
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Maximum age
24
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2009
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Sample size
Target
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Accrual to date
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Final
104
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Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
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Recruitment hospital [1]
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Royal Children's Hospital - Brisbane
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Recruitment hospital [2]
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Royal Children's Hospital - Parkville
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Recruitment hospital [3]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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4029 - Brisbane
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Recruitment postcode(s) [2]
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3052 - Parkville
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Recruitment postcode(s) [3]
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6001 - Perth
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Connecticut
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Delaware
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District of Columbia
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Bern
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Geneva
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00047320
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Trial related presentations / publications
Fangusaro J, Wu S, MacDonald S, Murphy E, Shaw D, Bartels U, Khatua S, Souweidane M, Lu HM, Morris D, Panigrahy A, Onar-Thomas A, Fouladi M, Gajjar A, Dhall G. Phase II Trial of Response-Based Radiation Therapy for Patients With Localized CNS Nongerminomatous Germ Cell Tumors: A Children's Oncology Group Study. J Clin Oncol. 2019 Dec 1;37(34):3283-3290. doi: 10.1200/JCO.19.00701. Epub 2019 Sep 23.
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Public notes
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Contacts
Principal investigator
Name
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Stewart Goldman, MD
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Address
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Ann & Robert H Lurie Children's Hospital of Chicago
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00047320
Download to PDF