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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

5 Years
Open (Enrolling)
Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Gastrointestinal Complications, Long-term Effects Secondary to Cancer Therapy in Children, Neurotoxicity, Ovarian Cancer, Pulmonary Complications, Sexual Dysfunction and Infertility, Sexuality and Reproductive Issues, Urinary Complications

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Trial Information

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


- 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

- 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

- 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.

Inclusion Criteria


- 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

- No recurrent or progressive disease


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


- See Disease Characteristics

Type of Study:


Study Design:


Outcome Measure:

Ototoxicity as measured by audiogram and Health Utilities Index in patients previously treated with cisplatin or carboplatin

Safety Issue:


Principal Investigator

Adam Glaser, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Leeds Cancer Centre at St. James's University Hospital



Study ID:




Start Date:

June 2006

Completion Date:

Related Keywords:

  • Childhood Germ Cell Tumor
  • Extragonadal Germ Cell Tumor
  • Gastrointestinal Complications
  • Long-term Effects Secondary to Cancer Therapy in Children
  • Neurotoxicity
  • Ovarian Cancer
  • Pulmonary Complications
  • Sexual Dysfunction and Infertility
  • Sexuality and Reproductive Issues
  • Urinary Complications
  • 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
  • Infertility
  • Ovarian Neoplasms
  • Sexual Dysfunctions, Psychological
  • Neoplasms, Germ Cell and Embryonal
  • Neurotoxicity Syndromes