Clinical trial · Interventional
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
NCT00053352CI-TRIAL-00052650completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (18)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Embryonal Tumor | Embryonal Neoplasm | CURATED_BROADER | 0.80 |
| Childhood Extracranial Germ Cell Tumor | Childhood Extracranial Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Childhood Extragonadal Germ Cell Tumor | Extragonadal Germ Cell Tumor | ONTOLOGY_EXACT | 0.85 |
| Childhood Malignant Ovarian Germ Cell Tumor | Childhood Malignant Ovarian Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Childhood Malignant Testicular Germ Cell Tumor | Childhood Malignant Testicular Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Childhood Teratoma | Childhood Teratoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Embryonal Carcinoma |
Interventions
Interventions (5)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Procedure: conventional surgery
- Drug: cisplatin
- Drug: etoposide
- Biological: bleomycin sulfate
- Other: laboratory biomarker analysis
- type
- NO_INTERVENTION
- label
- Arm 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDO'Neill AF, Xia C, Krailo MD, Shaikh F, Pashankar FD, Billmire DF, Olson TA, Amatruda JF, Villaluna D, Huang L, Malogolowkin M, Rodriguez-Galindo C, Frazier AL. alpha-Fetoprotein as a predictor of outcome for children with germ cell tumors: A report from the Malignant Germ Cell International Consortium. Cancer. 2019 Oct 15;125(20):3649-3656. doi: 10.1002/cncr.32363. Epub 2019 Jul 29. PMID 31355926