Phase 3
Completed N=203
Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors
Extragonadal Germ Cell Tumor · Teratoma · testicular germ cell tumor
Source: ClinicalTrials.gov NCT00104676 ↗
Enrolled (actual)
203
Serious AEs
46.8%
Results posted
Jun 2021
Primary outcomePrimary: Progression-free Survival Rate After 1 Course of Treatment — 48; 59 percentage of participants — p=0.05
◆ Published Evidence
Highly cited
▲ Trending
200citations · ~17 / year
Personalised chemotherapy based on tumour marker decline in poor prognosis germ-cell tumours (GETUG 13): a phase 3, multicentre, randomised trial.
Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III non-seminomatous germ cell tumors.
Linked Publications (2)
-
Personalised chemotherapy based on tumour marker decline in poor prognosis germ-cell tumours (GETUG 13): a phase 3, multicentre, randomised trial.
-
Personalized Chemotherapy on the Basis of Tumor Marker Decline in Poor-Prognosis Germ-Cell Tumors: Updated Analysis of the GETUG-13 Phase III Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival Rate After 1 Course of Treatment |
48; 59 | 0.05 |
| SECONDARY Overall Survival |
65; 73 | 0.34 |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of non-seminomatous germ cell tumors (NSGCT) as evidenced by 1 of the following criteria:
- Histologically confirmed NSGCT
- Clinical evidence of disease AND high serum human chorionic gonadotropin (HCG) or alpha-fetoprotein (AFP) levels
- Clinical stage II-III disease (disseminated disease)
- Testicular, retroperitoneal, or mediastinal primary site
- Poor prognosis disease, meeting 1 of the following criteria:
- Mediastinal primary site
- Non-pulmonary visceral metastases
- One of the following lab values:
- HCG > 50,000 UI/L
- AFP > 10,000 ng/mL
- Lactate dehydrogenase > 10 times upper limit of normal (ULN)
PATIENT CHARACTERISTICS:
Age
- Over 16
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times ULN
Renal
- Creatinine clearance > 60 mL/min
Other
- No other prior malignancy except basal cell skin cancer
- No HIV positivity
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Data sourced from ClinicalTrials.gov (NCT00104676) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.