Positron Emission Tomography in Detecting Testicle Cancer
NCT ID: NCT00045045
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
2002-05-31
2007-07-31
Brief Summary
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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.
Detailed Description
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* Assess the ability of fludeoxyglucose F 18 positron emission tomography to predict relapse requiring adjuvant chemotherapy in patients with high-risk stage I non-seminomatous or mixed seminoma/non-seminomatous germ cell tumor of the testis who are on current management protocols.
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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
DIAGNOSTIC
Interventions
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positron emission tomography
fludeoxyglucose F 18
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed non-seminomatous or mixed seminoma/non-seminomatous germ cell tumor of the testis with evidence of vascular (lymphatic or venous) invasion in primary specimen
* Clinical stage I on the basis of clinical examination, chest x-ray, and CT scan of the chest, abdomen, and pelvis
* Negative post-orchidectomy tumor markers (alpha-fetoprotein and beta human chorionic gonadotropin)
* High-risk disease
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* No evidence of active inflammatory or infective diseases
* No other disease or prior malignancy that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
* No more than 8 weeks since prior orchidectomy
Other
* No prior positron emission tomography scans
MALE
No
Sponsors
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Institute of Cancer Research, United Kingdom
OTHER
Principal Investigators
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Robert A. Huddart, MD
Role: STUDY_CHAIR
Royal Marsden NHS Foundation Trust
Locations
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Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
Ipswich Hospital NHS Trust
Ipswich, England, United Kingdom
Guy's and St. Thomas' Hospitals NHS Foundation Trust
London, England, United Kingdom
Meyerstein Institute of Oncology at University College of London Hospitals
London, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Royal South Hants Hospital
Southampton, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom
Countries
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References
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Huddart RA, O'Doherty MJ, Padhani A, Rustin GJ, Mead GM, Joffe JK, Vasey P, Harland SJ, Logue J, Daugaard G, Hain SF, Kirk SJ, MacKewn JE, Stenning SP; NCRI Testis Tumour Clinical Study Group. 18fluorodeoxyglucose positron emission tomography in the prediction of relapse in patients with high-risk, clinical stage I nonseminomatous germ cell tumors: preliminary report of MRC Trial TE22--the NCRI Testis Tumour Clinical Study Group. J Clin Oncol. 2007 Jul 20;25(21):3090-5. doi: 10.1200/JCO.2006.09.3831.
Other Identifiers
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MRC-TE22
Identifier Type: -
Identifier Source: secondary_id
EU-20115
Identifier Type: -
Identifier Source: secondary_id
CDR0000256314
Identifier Type: -
Identifier Source: org_study_id