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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: February 15, 2007
Last updated: August 9, 2013
Last verified: June 2009

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 Intervention
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Gastrointestinal Complications
Long-term Effects Secondary to Cancer Therapy in Children
Ovarian Cancer
Pulmonary Complications
Sexual Dysfunction
Urinary Complications
Procedure: assessment of therapy complications
Procedure: quality-of-life assessment

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Ototoxicity as measured by audiogram and Health Utilities Index in patients previously treated with cisplatin or carboplatin [ Designated as safety issue: Yes ]
  • Nephrotoxicity as measured by serum magnesium, calcium, and creatinine and glomerular filtration rate in patients previously treated with cisplatin or carboplatin [ Designated as safety issue: Yes ]
  • Myelodysplasia and second malignancies in patients previously treated with etoposide [ Designated as safety issue: No ]
  • Pulmonary toxicity as measured by lung function test and respiratory symptom questionnaire in patients previously treated with bleomycin [ Designated as safety issue: Yes ]
  • 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 [ Designated as safety issue: No ]
  • Quality of life (QOL) as measured by pediatric cancer quality-of-life inventory or Short Form 36 questionnaires [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2006
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • No patient deemed unsuitable for this study by the treating clinician


  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00436774

Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12
United Kingdom
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Great Ormond Street Hospital for Children
London, England, United Kingdom, WC1N 3JH
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom, EH9 1LF
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom, G3 8SJ
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Study Chair: Adam Glaser, MD Leeds Cancer Centre at St. James's University Hospital
  More Information Identifier: NCT00436774     History of Changes
Other Study ID Numbers: CCLG-GC-2006-06  CDR0000531140  EU-20642 
Study First Received: February 15, 2007
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
long-term effects secondary to cancer therapy in children
gastrointestinal complications
pulmonary complications
sexual dysfunction
urinary complications
childhood extragonadal germ cell tumor
childhood malignant ovarian germ cell tumor
childhood malignant testicular germ cell tumor
childhood teratoma

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Neurotoxicity Syndromes
Genital Diseases, Male
Genital Diseases, Female
Neoplasms by Histologic Type
Nervous System Diseases
Chemically-Induced Disorders processed this record on January 14, 2017