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Sponsored by: |
Institute of Cancer Research - London |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045045 |
RATIONALE: Imaging procedures such as positron emission tomography may improve the ability to detect the extent of cancer and allow doctors to plan more effective treatment for patients who have testicle cancer.
PURPOSE: Diagnostic trial to study the effectiveness of positron emission tomography using fludeoxyglucose F 18 in predicting relapse in patients who have stage I germ cell tumor of the testicle.
Condition | Intervention |
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Testicular Germ Cell Tumor |
Drug: fludeoxyglucose F 18 Procedure: positron emission tomography |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Active Control |
Official Title: | A Study Of 18 FDG PET In The Prediction Of Relapse In Patients With A Clinical Stage I Non-Seminomatous Germ Cell Tumor |
Study Start Date: | May 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive fludeoxyglucose F 18 (FDG) IV followed 1 hour later by positron emission tomography (PET) imaging. Patients with metastatic disease identified by FDG PET imaging may receive adjuvant chemotherapy according to the standard clinical practice at each participating center. Patients with no metastatic disease identified by FDG PET imaging are considered for entry into the MRC-TE08 trial (randomized trial of 2 CT scan frequencies in the surveillance of stage I teratoma) or are followed according to the standard surveillance schedule.
Patients with metastatic disease are followed every 6 months. Patients with no metastatic disease are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 4-6 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: Approximately 135 patients will be accrued for this study within 2-3 years.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United Kingdom, England | |
Guy's and St. Thomas' Hospitals NHS Foundation Trust | |
London, England, United Kingdom, SE1 9RT | |
Ipswich Hospital NHS Trust | |
Ipswich, England, United Kingdom, IP4 5PD | |
Meyerstein Institute of Oncology at University College of London Hospitals | |
London, England, United Kingdom, WIT 3AA | |
Nottingham City Hospital NHS Trust | |
Nottingham, England, United Kingdom, NG5 1PB | |
Royal Devon and Exeter Hospital | |
Exeter, England, United Kingdom, EX2 5DW | |
Royal Marsden NHS Foundation Trust - Surrey | |
Sutton, England, United Kingdom, SM2 5PT | |
Royal South Hants Hospital | |
Southampton, England, United Kingdom, 5O14OYG | |
United Kingdom, Scotland | |
Beatson Oncology Centre | |
Glasgow, Scotland, United Kingdom, G11 6NT |
Study Chair: | Robert A. Huddart, MD | Royal Marsden - Surrey |
Study ID Numbers: | CDR0000256314, MRC-TE22, EU-20115 |
Study First Received: | September 6, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00045045 |
Health Authority: | United States: Federal Government |
stage I malignant testicular germ cell tumor testicular choriocarcinoma testicular choriocarcinoma and embryonal carcinoma testicular choriocarcinoma and seminoma testicular choriocarcinoma and teratoma testicular choriocarcinoma and yolk sac tumor testicular embryonal carcinoma and seminoma testicular embryonal carcinoma and teratoma with seminoma |
testicular embryonal carcinoma and teratoma testicular embryonal carcinoma and yolk sac tumor with seminoma testicular embryonal carcinoma and yolk sac tumor testicular embryonal carcinoma testicular teratoma testicular yolk sac tumor and teratoma with seminoma testicular yolk sac tumor and teratoma testicular yolk sac tumor |
Neoplasms, Germ Cell and Embryonal Choriocarcinoma Seminoma Testicular cancer |
Nonseminomatous germ cell tumor Testicular Neoplasms Teratoma Carcinoma |
Neoplasms Neoplasms by Histologic Type |