Brief Title
Treatment Outcome and Quality of Life in Patients With Pediatric Extra-Cranial Germ Cell Tumors Previously Treated on Clinical Trial CCLG-GC-1979-01 or CCLG-GC-1989-01
Official Title
Cross-Sectional Evaluation of Outcome Following Extra-Cranial Germ Cell Tumors Treated According to UKCCSG GC 7901 (GC I) and GC 8901 (GC II) Protocols
Brief Summary
RATIONALE: Treatment for pediatric extracranial germ cell tumors may cause side effects and
secondary cancers later in life. A study that evaluates patients after receiving combination
chemotherapy or surgery may help doctors understand the side effects and secondary cancers
that occur later in life.
PURPOSE: This study is looking at treatment outcome and quality of life in patients with
pediatric extracranial germ cell tumors previously treated on clinical trial CCLG-GC-1979-01
or CCLG-GC-1989-01.
Detailed Description
OBJECTIVES:
- Determine the late effects of treatment and the quality-of-life of patients with germ
cell tumors (GCT) previously treated on clinical trial CCLG-GC-1979-01 or
CCLG-GC-1989-01.
- Evaluate the late effects of carboplatin, etoposide, and bleomycin in patients treated
on clinical trial CCLG-GC-1989-01.
- Determine the toxicity of bleomycin and a combination of either cisplatin and
vinblastine, etoposide and cisplatin, or carboplatin and etoposide in patients treated
on clinical trial CCLG-GC-1979-01.
- Evaluate tumor-associated/surgical morbidity (bladder, bowel, and lower limb function)
in patients with malignant sacrococcygeal tumors treated in these clinical trials.
- Evaluate tumor-associated/surgical morbidity (sexual function/fertility) in patients
with malignant gonadal or pelvic GCTs.
- Evaluate tumor-associated/surgical morbidity (respiratory function) in patients with
thoracic GCTs.
- Develop a methodology and recommendations for the prospective late evaluation of
patients treated on future extracranial GCT clinical trials and those included in this
study.
- Inform clinicians about the late effects of treatment of malignant GCTs and advise them
on what long-term care these patients require.
OUTLINE: This is a cohort, multicenter study.
Patients complete questionnaires about ototoxicity, bladder and bowel dysfunction, and sexual
function and fertility as appropriate. They also complete a health-related quality-of-life
questionnaire over 20 minutes.
Treating physicians complete a lower-limb and neurologic dysfunction questionnaire. Data from
myelodysplasia, second malignancy, ototoxicity, nephrotoxicity, and pulmonary toxicity
assessments are collected from the patient's treating physician.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Study Type
Observational
Primary Outcome
Ototoxicity as measured by audiogram and Health Utilities Index in patients previously treated with cisplatin or carboplatin
Condition
Childhood Germ Cell Tumor
Intervention
assessment of therapy complications
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
60
Start Date
June 2006
Primary Completion Date
September 2010
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Previously enrolled in 1 of the following United Kingdom Children's Cancer Study Group
(UKCCSG) clinical trials for treatment of extracranial germ cell tumors:
- CCLG-GC-1989-01
- CCLG-GC-1979-01
- Received bleomycin or cisplatin therapy
- At least 5 years since completion of therapy in these clinical trials
- Attending or in contact with a UKCCSG center
- Patients treated for sacrococcygeal teratomas and discharged from follow-up are
eligible
- No recurrent or progressive disease
PATIENT CHARACTERISTICS:
- No patient deemed unsuitable for this study by the treating clinician
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Gender
All
Ages
5 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Adam Glaser, MD, ,
Location Countries
Ireland
Location Countries
Ireland
Administrative Informations
NCT ID
NCT00436774
Organization ID
CCLG-GC-2006-06
Secondary IDs
CDR0000531140
Study Sponsor
Children's Cancer and Leukaemia Group
Study Sponsor
Adam Glaser, MD, Study Chair, Leeds Cancer Centre at St. James's University Hospital
Verification Date
June 2009