Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors
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ClinicalTrials.gov Identifier: NCT00053352 |
Recruitment Status :
Completed
First Posted : January 28, 2003
Results First Posted : December 8, 2017
Last Update Posted : July 13, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Childhood Embryonal Tumor Childhood Extracranial Germ Cell Tumor Childhood Extragonadal Germ Cell Tumor Childhood Malignant Ovarian Germ Cell Tumor Childhood Malignant Testicular Germ Cell Tumor Childhood Teratoma Ovarian Embryonal Carcinoma Ovarian Yolk Sac Tumor Stage II Malignant Testicular Germ Cell Tumor Stage IIA Ovarian Germ Cell Tumor Stage IIB Ovarian Germ Cell Tumor Stage IIC Ovarian Germ Cell Tumor Stage III Malignant Testicular Germ Cell Tumor Stage IIIA Ovarian Germ Cell Tumor Stage IIIB Ovarian Germ Cell Tumor Stage IIIC Ovarian Germ Cell Tumor Testicular Choriocarcinoma and Yolk Sac Tumor Testicular Embryonal Carcinoma | Procedure: conventional surgery Drug: cisplatin Drug: etoposide Biological: bleomycin sulfate Other: laboratory biomarker analysis | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 302 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors |
Actual Study Start Date : | November 3, 2003 |
Actual Primary Completion Date : | October 1, 2013 |
Actual Study Completion Date : | June 30, 2021 |

Arm | Intervention/treatment |
---|---|
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. |
Procedure: conventional surgery
Other Name: surgery, conventional Drug: cisplatin Given IV
Other Names:
Drug: etoposide Given IV
Other Names:
Biological: bleomycin sulfate Given IV
Other Names:
Other: laboratory biomarker analysis Correlative studies |
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 |
- Event-Free Survival (EFS) [ Time Frame: 3 Years after enrollment ]Proportion of patients event free at 3 years following enrollment. Event-free survival is not a primary outcome measure for Arm 2 patients.
- Overall Survival (OS) [ Time Frame: 3 Years after enrollment ]Percentage probability of being alive at 3 years following enrollment.
- Days Hospitalized for Patients Who Receive Chemotherapy [ Time Frame: Up to 126 days after the start of chemotherapy ]Calculated to quantify the treatment cost associated with this regimen.
- Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Up to 126 days after the start of chemotherapy ]The number of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher at any time during protocol therapy

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Ages Eligible for Study: | up to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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
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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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053352

Principal Investigator: | Anne Frazier, MD | Children's Oncology Group |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Children's Oncology Group |
ClinicalTrials.gov Identifier: | NCT00053352 |
Other Study ID Numbers: |
AGCT0132 NCI-2009-00373 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000269433 ( Other Identifier: Clinical Trials.gov ) COG-AGCT0132 ( Other Identifier: Children's Oncology Group ) U10CA098543 ( U.S. NIH Grant/Contract ) |
First Posted: | January 28, 2003 Key Record Dates |
Results First Posted: | December 8, 2017 |
Last Update Posted: | July 13, 2021 |
Last Verified: | July 2021 |
Carcinoma Neoplasms Neoplasms, Germ Cell and Embryonal Germinoma Ovarian Neoplasms Teratoma Testicular Neoplasms Carcinoma, Embryonal Endodermal Sinus Tumor Choriocarcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases |
Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases Endocrine System Diseases Gonadal Disorders Genital Neoplasms, Male Genital Diseases, Male Male Urogenital Diseases Testicular Diseases Mesonephroma |