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

NCT00436774 | Unknown

• 3 other identifiers: CCLG-GC-2006-06CDR0000531140EU-20642
• Study Type: observational
• Target: 60
• Locations: 2 countries
• Sites: 13

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.

Conditions

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

Keywords

long-term effects secondary to cancer therapy in children; neurotoxicity; gastrointestinal complications; pulmonary complications; sexual dysfunction; infertility; urinary complications; childhood extragonadal germ cell tumor; childhood malignant ovarian germ cell tumor; childhood malignant testicular germ cell tumor; childhood teratoma

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

assessment of therapy complications PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Cancer and Leukaemia Group: lead

Study Sites (13)

Our Lady's Hospital for Sick Children Crumlin

Dublin, 12, Ireland

RECRUITING

Institute of Child Health at University of Bristol

Bristol, England, BS2 8AE, United Kingdom

RECRUITING

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

RECRUITING

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

RECRUITING

Great Ormond Street Hospital for Children

London, England, WC1N 3JH, United Kingdom

RECRUITING

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

RECRUITING

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

RECRUITING

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

RECRUITING

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

RECRUITING

Royal Aberdeen Children's Hospital

Aberdeen, Scotland, AB25 2ZG, United Kingdom

RECRUITING

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

RECRUITING

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

RECRUITING

Childrens Hospital for Wales

Cardiff, Wales, CF14 4XW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Infertility; Neurotoxicity Syndromes; Ovarian Neoplasms; Sexual Dysfunction, Physiological; Ovarian Germ Cell Cancer; Testicular Neoplasms; Teratoma

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Male Urogenital Diseases; Testicular Diseases; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type

Study Officials

• Adam Glaser, MD

  Leeds Cancer Centre at St. James's University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 15, 2007
• First Posted: February 19, 2007
• Study Start: June 1, 2006
• Primary Completion: September 1, 2010
• Last Updated: August 12, 2013

Record last verified: 2009-06

Locations

GB (12); IE (1)