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 because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00436774
First received: February 15, 2007
Last updated: August 9, 2013
Last verified: June 2009
  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
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

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:

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: Contact Person    353-1-409-6653      
United Kingdom
Institute of Child Health at University of Bristol Recruiting
Bristol, England, United Kingdom, BS2 8AE
Contact: Contact Person    44-117-342-8811      
Addenbrooke's Hospital Recruiting
Cambridge, England, United Kingdom, CB2 2QQ
Contact: Contact Person    44-1223-256-298      
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   
Great Ormond Street Hospital for Children Recruiting
London, England, United Kingdom, WC1N 3JH
Contact: Gill Levitt, MD    44-20-7405-9200 ext. 0073      
Sir James Spence Institute of Child Health at Royal Victoria Infirmary Recruiting
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Contact: Juliet Hale, MD    44-191-282-4101    j.p.hale@ncl.ac.uk   
Children's Hospital - Sheffield Recruiting
Sheffield, England, United Kingdom, S10 2TH
Contact: Mary P. Gerrard, MBChB, FRCP, FRCPCH    44-114-271-7366    mary.gerrard@sch.nhs.uk   
Southampton General Hospital Recruiting
Southampton, England, United Kingdom, SO16 6YD
Contact: Janice A. Kohler, MD, FRCP    44-23-8079-6942      
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Mary Taj, MD    44-20-8642-6011 ext. 1307      
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
Edinburgh, Scotland, United Kingdom, EH9 1LF
Contact: W. Hamish Wallace, MD    44-131-536-0426      
Royal Hospital for Sick Children Recruiting
Glasgow, Scotland, United Kingdom, G3 8SJ
Contact: Milind D. Ronghe, MD    44-141-201-9309      
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

Additional Information:
No publications provided

ClinicalTrials.gov 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
childhood extragonadal germ cell tumor
childhood malignant ovarian germ cell tumor
childhood malignant testicular germ cell tumor
neurotoxicity
gastrointestinal complications
pulmonary complications
sexual dysfunction
infertility
urinary complications
childhood teratoma

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Germ Cell and Embryonal
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Histologic Type
Infertility
Sexual Dysfunctions, Psychological
Neurotoxicity Syndromes
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Sexual and Gender Disorders
Mental Disorders
Nervous System Diseases
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on April 15, 2014