Observation and/or Combination Chemotherapy After Surgery or Biopsy in Treating Young Patients With Extracranial Germ Cell Tumors
NCT00274950 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105
Last updated 2013-09-17
Summary
RATIONALE: Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. 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. Giving combination chemotherapy after surgery may kill any remaining tumor cells.
PURPOSE: This phase III trial is studying how well observation and/or combination chemotherapy works after surgery or biopsy in treating young patients with extracranial germ cell tumors.
Conditions
- Childhood Germ Cell Tumor
- Extragonadal Germ Cell Tumor
- Ovarian Cancer
Interventions
- BIOLOGICAL
-
bleomycin sulfate
- DRUG
- DRUG
- DRUG
-
etoposide
- DRUG
-
ifosfamide
- DRUG
-
vinblastine sulfate
- PROCEDURE
-
adjuvant therapy
- PROCEDURE
-
conventional surgery
Sponsors & Collaborators
-
Children's Cancer and Leukaemia Group
lead OTHER
Principal Investigators
-
Juliet Hale, MD · Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Study Design
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-05-31
- Primary Completion
- 2010-05-31
Countries
- Ireland
- United Kingdom
Study Locations
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