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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
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008
Sponsored by: Children's Cancer and Leukaemia Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00436774
  Purpose

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
Cancer-Related Problem/Condition
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Ovarian Cancer
Procedure: assessment of therapy complications
Procedure: quality-of-life assessment

MedlinePlus related topics: Cancer Infertility Ovarian Cancer
U.S. FDA Resources
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

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:

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.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436774

Locations
Ireland
Our Lady's Hospital for Sick Children Crumlin Recruiting
Dublin, Ireland, 12
Contact: Fin Breatnach, MD, FRCPE     353-1-409-6659     fin.breatnach@olhsc.ie    
United Kingdom, England
Addenbrooke's Hospital Recruiting
Cambridge, England, United Kingdom, CB2 2QQ
Contact: Amos Burke, MD     44-1223-348-151        
Birmingham Children's Hospital Recruiting
Birmingham, England, United Kingdom, B4 6NH
Contact: Martin W. English, MD     44-121-333-8412     martin.english@bch.nhs.uk    
Children's Hospital - Sheffield Recruiting
Sheffield, England, United Kingdom, S10 2TH
Contact: Mary P. Gerrard, BSc, MBChB, FRCP, FRCPCH     44-114-271-7366     mary.gerrard@sch.nhs.uk    
Great Ormond Street Hospital for Children Recruiting
London, England, United Kingdom, WC1N 3JH
Contact: Gill Levitt, MD     44-20-7405-9200 ext. 0073        
Oxford Radcliffe Hospital Recruiting
Oxford, England, United Kingdom, 0X3 9DU
Contact: Kate Wheeler, MD     44-186-522-1066        
Leeds Cancer Centre at St. James's University Hospital Recruiting
Leeds, England, United Kingdom, LS9 7TF
Contact: Adam Glaser, MD     44-113-206-4984     adam.glaser@leedsth.nhs.uk    
Leicester Royal Infirmary Recruiting
Leicester, England, United Kingdom, LE1 5WW
Contact: Mabrouk Madi, MD     44-116-258-5959        
Middlesex Hospital Recruiting
London, England, United Kingdom, W1T 3AA
Contact: Ananth Shankar, MD     44-20-7380-9300 ext. 9950        
Institute of Child Health at University of Bristol Recruiting
Bristol, England, United Kingdom, BS2 8AE
Contact: Pamela Kearns, MD     44-117-342-8260        
Queen's Medical Centre Recruiting
Nottingham, England, United Kingdom, NG7 2UH
Contact: Martin Hewitt, MD, BSc, FRCP, FRCPCH     44-115-924-9924 ext. 43394     martin.hewitt@nuh.nhs.uk    
Royal Liverpool Children's Hospital, Alder Hey Recruiting
Liverpool, England, United Kingdom, L12 2AP
Contact: Heather P. McDowell, MD     44-151-293-3679        
Royal Manchester Children's Hospital Recruiting
Manchester, England, United Kingdom, M27 4HA
Contact: Bernadette Brennan, MD     44-161-922-2227     bernadette.brennan@cmmc.nhs.uk    
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Mary Taj, MD     44-20-8642-6011 ext. 1307        
Sir James Spence Institute of Child Health Recruiting
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Contact: Juliet Hale, MD     44-191-282-4101     j.p.hale@ncl.ac.uk    
Southampton General Hospital Recruiting
Southampton, England, United Kingdom, SO16 6YD
Contact: Janice A. Kohler, MD, FRCP     44-23-8079-6942        
United Kingdom, Northern Ireland
Royal Belfast Hospital for Sick Children Recruiting
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Contact: Anthony McCarthy, MD     44-289-063-3631     anthonymcarthy@royalhospital.n.i.nhs.uk    
United Kingdom, Scotland
Royal Aberdeen Children's Hospital Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Contact: Veronica Neefjes     44-1224-550-217        
Royal Hospital for Sick Children Recruiting
Glasgow, Scotland, United Kingdom, G3 8SJ
Contact: Milind D. Ronghe, MD     44-141-201-9309        
Royal Hospital for Sick Children Recruiting
Edinburgh, Scotland, United Kingdom, EH9 1LF
Contact: W. Hamish Wallace, MD     44-131-536-0426        
United Kingdom, Wales
Childrens Hospital for Wales Recruiting
Cardiff, Wales, United Kingdom, CF14 4XW
Contact: Heidi Traunecker, MD, PhD     44-29-2074-2285     heidi.traunecker@cardiffandvale.wales.nhs.uk    
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
Study Chair: Adam Glaser, MD Leeds Cancer Centre at St. James's University Hospital
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000531140, CCLG-GC-2006-06, EU-20642
Study First Received: February 15, 2007
Last Updated: October 17, 2008
ClinicalTrials.gov Identifier: NCT00436774  
Health Authority: Unspecified

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

Study placed in the following topic categories:
Ovarian cancer
Infertility
Ovarian Neoplasms
Neurotoxicity Syndromes
Gonadal Disorders
Neurotoxicity syndromes
Genital Neoplasms, Female
Quality of Life
Endocrine System Diseases
Urogenital Neoplasms
Testicular Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Testicular cancer
Endocrinopathy
Teratoma
Extragonadal Germ Cell Tumor
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 15, 2009