OncoMatch/Clinical Trials/NCT03067181
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
Is NCT03067181 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Bleomycin Sulfate and Carboplatin for childhood extracranial germ cell tumor.
Treatment: Bleomycin Sulfate · Carboplatin · Cisplatin · Etoposide — This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Testicular Germ Cell Tumor
Biomarker criteria
Required: AFP overexpression (< 1000 ng/mL)
Low risk immature teratoma (IT); ... tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG institutional normal
Required: HCG institutional normal (institutional normal)
Low risk immature teratoma (IT); ... tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG institutional normal
Required: AFP overexpression (< 1000 ng/mL)
Site: testicular; ... post op: alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) < 3.0 x normal; age (years) >= 11 and < 25
Required: HCG overexpression (< 5,000 IU/mL)
Site: testicular; ... post op: alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) < 3.0 x normal; age (years) >= 11 and < 25
Required: LDHA overexpression (< 3.0 x normal)
Site: testicular; ... post op: alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) < 3.0 x normal; age (years) >= 11 and < 25
Excluded: AFP overexpression
Pure immature teratoma with alpha-fetoprotein (AFP) >= 1000 ng/mL [excluded]
Allowed: AFP elevated tumor marker (> 5 x ULN on at least 2 measurements taken at least 1 week apart)
elevated tumor markers rise to > 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart
Allowed: AFP overexpression
exceptionally raised tumor markers (alpha fetoprotein [AFP- ≥ 500 ng/mL ...])
Allowed: HCG overexpression
exceptionally raised tumor markers (... HCG ≥ 500 IU/L)
Disease stage
Required: Stage I, II, III, IV
Performance status
ECOG/KARNOFSKY/LANSKY 0–3
ECOG scores of 0, 1, 2 or 3; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
Prior therapy
Cannot have received: systemic therapy
Exception: Patients with prior cisplatin- or carboplatin-based chemotherapy for malignancy (including diagnoses other than germ cell tumor) may participate in the AYA-HEARS pilot study only
Patients must have had no prior systemic therapy for the current cancer diagnosis
Cannot have received: radiation therapy
Exception: CNS irradiation of brain metastases allowed only for SR1 patients
Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain [stage IV disease] would be considered poor risk and therefore not eligible for this trial)
Lab requirements
Blood counts
ANC >= 750/mm^3; Platelet count >= 75,000/mm^3
Kidney function
Creatinine clearance or GFR >= 70 mL/min/1.73 m^2 OR age/sex-based serum creatinine thresholds
Liver function
Total bilirubin <= 2 x ULN for age (unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome); AST and ALT < 3 x ULN (unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome)
Adequate renal function ... Total bilirubin <= 2 x ULN ... AST and ALT < 3 x ULN ... ANC >= 750/mm^3 ... Platelet count >= 75,000/mm^3
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital of Alabama · Birmingham, Alabama
- USA Health Strada Patient Care Center · Mobile, Alabama
- Anchorage Associates in Radiation Medicine · Anchorage, Alaska
- Anchorage Radiation Therapy Center · Anchorage, Alaska
- Alaska Breast Care and Surgery LLC · Anchorage, Alaska
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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