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	Treatment or Intervention
Testicular Cancer	Drug: fludeoxyglucose F 18  Procedure: diagnostic test  Procedure: tomography, emission computed

Further Study Details: 

OBJECTIVES:

• 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.

PROJECTED ACCRUAL: Approximately 135 patients will be accrued for this study within 2-3 years.

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• 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

United Kingdom, England
      Guy's and St. Thomas' Hospitals NHS Foundation Trust, London,  England,  SE1 9RT,  United Kingdom
      Ipswich Hospital NHS Trust, Ipswich,  England,  IP4 5PD,  United Kingdom
      Meyerstein Institute of Oncology at University College of London Hospitals, London,  England,  WIT 3AA,  United Kingdom
      Nottingham City Hospital NHS Trust, Nottingham,  England,  NG5 1PB,  United Kingdom
      Royal Devon and Exeter Hospital, Exeter,  England,  EX2 5DW,  United Kingdom
      Royal Marsden NHS Foundation Trust - Surrey, Sutton,  England,  SM2 5PT,  United Kingdom
      Royal South Hants Hospital, Southampton,  England,  5O14OYG,  United Kingdom
United Kingdom, Scotland
      Beatson Oncology Centre, Glasgow,  Scotland,  G11 6NT,  United Kingdom

Study chairs or principal investigators

Robert Huddart, MD,  Study Chair,  Royal Marsden NHS Trust   

Study ID Numbers:  CDR0000256314; MRC-TE22; EU-20115; NCT00045045
Record last reviewed:  March 2005
Last Updated:  March 28, 2005
Record first received:  September 6, 2002
ClinicalTrials.gov Identifier:  NCT00045045
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08