Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
Phase 3 N=203 Randomized Treatment

Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors

Extragonadal Germ Cell Tumor · Teratoma · Testicular Germ Cell Tumor

Bottom Line

View on ClinicalTrials.gov: NCT00104676 ↗
Enrolled (actual)
203
Serious AEs
46.8%
Results posted
Jun 2021
Primary outcome: Primary: Progression-free Survival Rate After 1 Course of Treatment — 48; 59 percentage of participants — p=0.05

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
bleomycin sulfate (Biological); cisplatin (Drug); etoposide (Drug); ifosfamide (Drug); oxaliplatin (Drug); paclitaxel (Drug)
Age
Pediatric, Adult, Older Adult · 16+ yrs
Sex
All
Sponsor
UNICANCER
Primary completion
Mar 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Progression-free Survival Rate After 1 Course of Treatment		 48; 59 0.05
SECONDARY
Overall Survival		 65; 73 0.34

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00104676). 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.

Back to search