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

Sponsor

Children's Cancer and Leukaemia Group (Other)

Overall Status

Unknown status

CT.gov ID

NCT00436774

Collaborator

(none)

Enrollment

Locations

4.6

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Gastrointestinal Complications Infertility Long-term Effects Secondary to Cancer Therapy in Children Neurotoxicity Ovarian Cancer Pulmonary Complications Sexual Dysfunction Urinary Complications	Procedure: assessment of therapy complications Procedure: quality-of-life assessment

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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

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

Study Start Date :

Jun 1, 2006

Anticipated Primary Completion Date :

Sep 1, 2010

Outcome Measures

Primary Outcome Measures

Ototoxicity as measured by audiogram and Health Utilities Index in patients previously treated with cisplatin or carboplatin []
Nephrotoxicity as measured by serum magnesium, calcium, and creatinine and glomerular filtration rate in patients previously treated with cisplatin or carboplatin []
Myelodysplasia and second malignancies in patients previously treated with etoposide []
Pulmonary toxicity as measured by lung function test and respiratory symptom questionnaire in patients previously treated with bleomycin []
Bladder and bowel dysfunction, sexual function, and fertility as measured by patient-completed questionnaires and lower limb and neurological dysfunction as measured by clinician-completed questionnaires in patients with pelvic or sacrococcygeal tumors []
Quality of life (QOL) as measured by pediatric cancer quality-of-life inventory or Short Form 36 questionnaires []

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Our Lady's Hospital for Sick Children Crumlin	Dublin		Ireland	12
2	Institute of Child Health at University of Bristol	Bristol	England	United Kingdom	BS2 8AE
3	Addenbrooke's Hospital	Cambridge	England	United Kingdom	CB2 2QQ
4	Leeds Cancer Centre at St. James's University Hospital	Leeds	England	United Kingdom	LS9 7TF
5	Great Ormond Street Hospital for Children	London	England	United Kingdom	WC1N 3JH
6	Sir James Spence Institute of Child Health at Royal Victoria Infirmary	Newcastle-Upon-Tyne	England	United Kingdom	NE1 4LP
7	Children's Hospital - Sheffield	Sheffield	England	United Kingdom	S10 2TH
8	Southampton General Hospital	Southampton	England	United Kingdom	SO16 6YD
9	Royal Marsden - Surrey	Sutton	England	United Kingdom	SM2 5PT
10	Royal Aberdeen Children's Hospital	Aberdeen	Scotland	United Kingdom	AB25 2ZG
11	Royal Hospital for Sick Children	Edinburgh	Scotland	United Kingdom	EH9 1LF
12	Royal Hospital for Sick Children	Glasgow	Scotland	United Kingdom	G3 8SJ
13	Childrens Hospital for Wales	Cardiff	Wales	United Kingdom	CF14 4XW