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Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors
This study is currently recruiting participants.
Study NCT00053352   Information provided by National Cancer Institute (NCI)
First Received: January 27, 2003   Last Updated: November 7, 2009   History of Changes

January 27, 2003
November 7, 2009
November 2003
October 2010   (final data collection date for primary outcome measure)
Event-free survival [ Designated as safety issue: No ]
Event-free survival
Complete list of historical versions of study NCT00053352 on ClinicalTrials.gov Archive Site
 
 
 
Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors
A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors

RATIONALE: 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.

PURPOSE: 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.

OBJECTIVES:

  • Determine whether children with newly diagnosed low- or intermediate-risk extracranial germ cell tumors (GCTs) can maintain a 3-year event-free survival of at least 92% (for intermediate-risk tumors only) and overall survival of at least 95% (both low-risk and intermediate-risk tumors) after treatment with surgery followed by compressed cisplatin, etoposide, and bleomycin.
  • Determine the percentage of patients with stage I ovarian or stage I testicular GCTs for whom chemotherapy can be eliminated.
  • Determine the percentage of intermediate-risk patients who require only 3 courses of therapy.
  • Determine the acute toxic effects of compressed therapy in these patients.
  • Determine the long-term sequelae in patients treated with this regimen.
  • Determine the number of hospital days and total drug doses required for patients treated with compressed therapy.
  • Compare the number of protocol-directed treatment days used in CCG-8882 vs the number of treatment days used in this study.
  • Determine the cytogenetic and molecular genetic features in patients treated with this regimen.

OUTLINE: Patients are stratified according to disease risk (low vs intermediate).

  • Surgery: Patients undergo surgical resection.

    • Low-risk disease: Patients with gonadal primaries and no evidence of disease after surgery undergo monitoring for disease progression. Patients who remain disease free receive no further treatment. Patients who have disease progression after surgery receive compressed induction chemotherapy.
    • Intermediate-risk disease: After surgery, patients proceed to compressed induction chemotherapy.
  • Compressed induction therapy: Patients receive cisplatin IV over 90 minutes and etoposide IV over 90 minutes on days 1-3 and bleomycin IV over 10 minutes on day 1. Treatment repeats every 3 weeks for 3 courses (weeks 0, 3, and 6).

After completion of compressed induction chemotherapy, patients who have 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 who have abnormal tumor markers proceed to second-look surgery and/or compressed consolidation chemotherapy.

  • Second-look surgery: Patients undergo surgical resection of residual tumor. After surgery, patients who are in 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.
  • Compressed consolidation chemotherapy: Patients receive cisplatin, etoposide, and bleomycin as in induction chemotherapy in weeks 10, 13, and 16.

Patients are followed monthly for 6 months, every 3 months for 6 months, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 306 patients (126 with low-risk disease and 180 with intermediate-risk disease) will be accrued for this study within 6 years.

Phase III
Interventional
Treatment, Open Label
  • Childhood Germ Cell Tumor
  • Extragonadal Germ Cell Tumor
  • Ovarian Cancer
  • Biological: bleomycin sulfate
  • Drug: cisplatin
  • Drug: etoposide
  • Procedure: conventional surgery
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
306
 
October 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary extracranial germ cell tumor (GCT), including one of the following types:

    • Yolk sac tumor
    • Embryonal carcinoma
    • Choriocarcinoma
    • Mixed germ cell tumor

      • Immature teratoma*
      • Mature teratoma*
      • Dysgerminoma* NOTE: *Mixed with yolk sac tumor, embryonal carcinoma or choriocarcinoma
  • Patients with any of the following diagnosis are not allowed:

    • Intracranial germ cell tumors
    • Pure mature or immature teratoma
    • Pure dysgerminoma
    • Pure seminoma
  • Low-risk disease

    • Stage I malignant testicular GCT
    • Stage I malignant ovarian GCT
  • Intermediate-risk disease

    • Stage II, III, or IV malignant testicular GCT
    • Stage II or III malignant ovarian GCT
    • Stage I or II extragonadal GCT
  • Alpha-fetoprotein and beta human chorionic gonadotropin tumor markers known
  • Must be enrolled within 6 weeks of original diagnostic surgery

PATIENT CHARACTERISTICS:

Age

  • 21 and under at diagnosis (under 15 for patients with primary testicular tumors)

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Creatinine normal for age OR
  • Isotope glomerular filtration rate at least 50% normal OR
  • Creatinine clearance at least 60 mL/min

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics
Both
up to 21 Years
No
 
United States,   Australia,   Canada,   New Zealand,   Puerto Rico,   Switzerland
 
NCT00053352
Gregory H. Reaman, Children's Oncology Group - Group Chair Office
CDR0000269433, COG-AGCT0132
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: A. Lindsay Frazier, MD Dana-Farber Cancer Institute
National Cancer Institute (NCI)
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP