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
Primary Purpose
Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Gastrointestinal Complications
Status
Unknown status
Phase
Locations
International
Study Type
Observational
Intervention
assessment of therapy complications
quality-of-life assessment
Sponsored by
About this trial
This is an observational trial for Childhood Germ Cell Tumor focused on measuring 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
Eligibility 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
Sites / Locations
- Our Lady's Hospital for Sick Children CrumlinRecruiting
- Institute of Child Health at University of BristolRecruiting
- Addenbrooke's HospitalRecruiting
- Leeds Cancer Centre at St. James's University HospitalRecruiting
- Great Ormond Street Hospital for ChildrenRecruiting
- Sir James Spence Institute of Child Health at Royal Victoria InfirmaryRecruiting
- Children's Hospital - SheffieldRecruiting
- Southampton General HospitalRecruiting
- Royal Marsden - SurreyRecruiting
- Royal Aberdeen Children's HospitalRecruiting
- Royal Hospital for Sick ChildrenRecruiting
- Royal Hospital for Sick ChildrenRecruiting
- Childrens Hospital for WalesRecruiting
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00436774
First Posted
February 15, 2007
Last Updated
August 9, 2013
Sponsor
Children's Cancer and Leukaemia Group
1. Study Identification
Unique Protocol Identification Number
NCT00436774
Brief Title
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
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 Type
Observational
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Children's Cancer and Leukaemia Group
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
assessment of therapy complications
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Ototoxicity as measured by audiogram and Health Utilities Index in patients previously treated with cisplatin or carboplatin
Title
Nephrotoxicity as measured by serum magnesium, calcium, and creatinine and glomerular filtration rate in patients previously treated with cisplatin or carboplatin
Title
Myelodysplasia and second malignancies in patients previously treated with etoposide
Title
Pulmonary toxicity as measured by lung function test and respiratory symptom questionnaire in patients previously treated with bleomycin
Title
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
Title
Quality of life (QOL) as measured by pediatric cancer quality-of-life inventory or Short Form 36 questionnaires
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Glaser, MD
Organizational Affiliation
Leeds Cancer Centre at St. James's University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Our Lady's Hospital for Sick Children Crumlin
City
Dublin
ZIP/Postal Code
12
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
353-1-409-6653
Facility Name
Institute of Child Health at University of Bristol
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8AE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-117-342-8811
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1223-256-298
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Glaser, MD
Phone
44-113-206-4984
Email
adam.glaser@leedsth.nhs.uk
Facility Name
Great Ormond Street Hospital for Children
City
London
State/Province
England
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gill Levitt, MD
Phone
44-20-7405-9200 ext. 0073
Facility Name
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliet Hale, MD
Phone
44-191-282-4101
Email
j.p.hale@ncl.ac.uk
Facility Name
Children's Hospital - Sheffield
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary P. Gerrard, MBChB, FRCP, FRCPCH
Phone
44-114-271-7366
Email
mary.gerrard@sch.nhs.uk
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janice A. Kohler, MD, FRCP
Phone
44-23-8079-6942
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Taj, MD
Phone
44-20-8642-6011 ext. 1307
Facility Name
Royal Aberdeen Children's Hospital
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronica Neefjes
Phone
44-1224-550-217
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH9 1LF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
W. Hamish Wallace, MD
Phone
44-131-536-0426
Facility Name
Royal Hospital for Sick Children
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milind D. Ronghe, MD
Phone
44-141-201-9309
Facility Name
Childrens Hospital for Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Traunecker, MD, PhD
Phone
44-29-2074-2285
Email
heidi.traunecker@cardiffandvale.wales.nhs.uk
12. IPD Sharing Statement
Learn more about this trial
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
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