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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00053352




Registration number
NCT00053352
Ethics application status
Date submitted
27/01/2003
Date registered
28/01/2003
Date last updated
25/03/2020

Titles & IDs
Public title
Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors
Scientific title
A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors
Secondary ID [1] 0 0
NCI-2009-00373
Secondary ID [2] 0 0
AGCT0132
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Embryonal Tumor 0 0
Childhood Extracranial Germ Cell Tumor 0 0
Childhood Extragonadal Germ Cell Tumor 0 0
Childhood Malignant Ovarian Germ Cell Tumor 0 0
Childhood Malignant Testicular Germ Cell Tumor 0 0
Childhood Teratoma 0 0
Ovarian Embryonal Carcinoma 0 0
Ovarian Yolk Sac Tumor 0 0
Stage II Malignant Testicular Germ Cell Tumor 0 0
Stage IIA Ovarian Germ Cell Tumor 0 0
Stage IIB Ovarian Germ Cell Tumor 0 0
Stage IIC Ovarian Germ Cell Tumor 0 0
Stage III Malignant Testicular Germ Cell Tumor 0 0
Stage IIIA Ovarian Germ Cell Tumor 0 0
Stage IIIB Ovarian Germ Cell Tumor 0 0
Stage IIIC Ovarian Germ Cell Tumor 0 0
Testicular Choriocarcinoma and Yolk Sac Tumor 0 0
Testicular Embryonal Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Testicular
Cancer 0 0 0 0
Other cancer types
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - conventional surgery
Treatment: Drugs - cisplatin
Treatment: Drugs - etoposide
Other interventions - bleomycin sulfate
Other interventions - laboratory biomarker analysis

Experimental: Arm I - Patients enrolled with gonadal tumors of stage II or greater or extragonadal tumors of any stage receive cisplatin IV over 90 minutes & etoposide IV over 90 minutes days 1-3 and bleomycin sulfate IV over = 10 minutes day 1. Treatment repeats every 3 weeks, 3 courses (weeks 0,3 & 6).
After completion of compressed induction chemotherapy, patients with no change in disease status or disease progression are removed from study. Patients with no evidence of disease receive no further therapy. Patients with a partial response or abnormal tumor markers proceed to conventional surgery (second-look) and/or 3 more courses of compressed consolidation chemotherapy.
After surgery, patients with pathologic complete response and have normal tumor markers receive no further therapy. Patients who remain with a partial response after surgery receive compressed consolidation chemotherapy.
Patients receive cisplatin, etoposide, and bleomycin as induction chemotherapy in weeks 10,13, & 16.

No Intervention: Arm 2 - Patients who are enrolled with stage I gonadal tumors receive no further anticancer therapy until evidence of tumor recurrence or the diagnosis of a second malignant neoplasm.
Observation only for recurrence or development of an SMN


Treatment: Surgery: conventional surgery


Treatment: Drugs: cisplatin
Given IV

Treatment: Drugs: etoposide
Given IV

Other interventions: bleomycin sulfate
Given IV

Other interventions: laboratory biomarker analysis
Correlative studies

Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-Free Survival (EFS) - Proportion of patients event free at 3 years following enrollment. Event-free survival is not a primary outcome measure for Arm 2 patients.
Timepoint [1] 0 0
3 Years after enrollment
Primary outcome [2] 0 0
Overall Survival (OS) - Percentage probability of being alive at 3 years following enrollment.
Timepoint [2] 0 0
3 Years after enrollment
Secondary outcome [1] 0 0
Days Hospitalized for Patients Who Receive Chemotherapy - Calculated to quantify the treatment cost associated with this regimen.
Timepoint [1] 0 0
Up to 126 days after the start of chemotherapy
Secondary outcome [2] 0 0
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 - The number of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher at any time during protocol therapy
Timepoint [2] 0 0
Up to 126 days after the start of chemotherapy

Eligibility
Key inclusion criteria
- Extracranial germ cell tumor that contains 1 of the following malignant histologies:
NOTE: Mixed germ cell tumors that include mature/immature teratoma are eligible
provided 1 of the 3 histologies listed above is also present in the tumor.

- Yolk sac tumor

- Embryonal carcinoma

- Choriocarcinoma

- Low-risk disease (closed to accrual as of 01/20/10)

- Stage I gonadal tumors (ovarian and testicular)

- Must have undergone complete surgical and radiologic staging to exclude the
possibility of > stage I disease

- Intermediate-risk disease

- Stage II, III, or IV malignant testicular GCT

- Stage II or III malignant ovarian GCT

- Stage I or II malignant extragonadal GCT

- Previously stage I gonadal patients who have relapsed on the low-risk
(observation) stratum of this study(closed to accrual as of 01/20/10)

- Patients with immature teratoma or mature teratoma who relapse with a malignant
component

- No patients with any of the following diagnoses:

- Stage IV ovarian and stage III-IV extragonadal GCT

- Intracranial GCT

- Pure mature or immature teratoma, pure dysgerminoma, or seminoma

- Patients with a non-germ cell component in their GCT (e.g., primitive
neuroectodermal tumors or rhabdomyosarcoma)

- Alpha-fetoprotein and beta human chorionic gonadotropin tumor markers known

- If > 5 days have elapsed from the time of obtaining original markers, tumor
markers must be repeated before enrollment of low-risk patients and before
initiating therapy in intermediate-risk patients (the results of the repeated
tumor markers do not have to be known at the time of study enrollment)

- Must be enrolled within 6 weeks of original diagnostic surgery

- Creatinine clearance or radioisotope GFR = 70 mL/min OR a serum creatinine based on
age/gender as follows:

- = 0.4 mg/dL (for patients 1 to 5 months of age)

- = 0.5 mg/dL (for patients 6 to 11 months of age)

- = 0.6 mg/dL (for patients 1 year of age)

- = 0.8 mg/dL (for patients 2 to 5 years of age)

- = 1.0 mg/dL (for patients 6 to 9 years of age)

- = 1.2 mg/dL (for patients 10 to 12 years of age)

- = 1.4 mg/dL (for female patients = 13 years of age)

- = 1.5 mg/dL (for male patients 13 to 15 years of age)

- = 1.7 mg/dL (for male patients = 16 years of age)

- No prior chemotherapy

- No prior radiotherapy
Minimum age
No limit
Maximum age
21 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Sydney
Recruitment hospital [2] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment postcode(s) [2] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
State/province [11] 0 0
Hawaii
Country [12] 0 0
United States of America
State/province [12] 0 0
Idaho
Country [13] 0 0
United States of America
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Illinois
Country [14] 0 0
United States of America
State/province [14] 0 0
Kentucky
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
New Hampshire
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
North Dakota
Country [24] 0 0
United States of America
State/province [24] 0 0
Ohio
Country [25] 0 0
United States of America
State/province [25] 0 0
Oklahoma
Country [26] 0 0
United States of America
State/province [26] 0 0
Oregon
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
Tennessee
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Utah
Country [32] 0 0
United States of America
State/province [32] 0 0
Vermont
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Washington
Country [35] 0 0
United States of America
State/province [35] 0 0
West Virginia
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United States of America
State/province [36] 0 0
Wisconsin
Country [37] 0 0
Canada
State/province [37] 0 0
Alberta
Country [38] 0 0
Canada
State/province [38] 0 0
British Columbia
Country [39] 0 0
Canada
State/province [39] 0 0
Ontario
Country [40] 0 0
Canada
State/province [40] 0 0
Quebec
Country [41] 0 0
Canada
State/province [41] 0 0
Saskatchewan
Country [42] 0 0
New Zealand
State/province [42] 0 0
Auckland
Country [43] 0 0
Puerto Rico
State/province [43] 0 0
Santurce
Country [44] 0 0
Switzerland
State/province [44] 0 0
Geneva

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This phase III trial is studying surgery followed by combination chemotherapy to see how well
it works in treating children with germ cell tumors that are not located in the head. Drugs
used in chemotherapy use different ways to stop tumor cells from dividing so they stop
growing or die. Combining more than one drug, and giving them after surgery, may kill any
remaining tumor cells following surgery. It is not yet known whether combination chemotherapy
is effective in decreasing the recurrence of childhood germ cell tumors.
Trial website
https://clinicaltrials.gov/show/NCT00053352
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anne Frazier, MD
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00053352