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Home > "P" Clinical Trials Conditions > Positron Emission Tomography in Detecting Testicle Cancer  Positron Emission Tomography in Detecting Testicle Cancer
Positron Emission Tomography in Detecting Testicle Cancer
For Condition: Testicular Cancer
Status: Recruiting
Sponsor(s): Medical Research Council ,
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertHuddart, Study Chair, Royal Marsden Hospital
Meyerstein Institute of Oncology at Middlesex Hospital *Recruiting*
London, England, WIT 3AA
United Kingdom
Recruiting Stephen Harland 20-7380-9041
Royal South Hants Hospital *Recruiting*
Southampton, England, 5O14OYG
United Kingdom
Recruiting Graham Mead 44-23-8082-5973
Royal Marsden Hospital - Sutton *Recruiting*
Sutton, England, SM2 5PT
United Kingdom
Recruiting Robert Huddart 44-20-8661-3457
Guy's and St. Thomas' Hospitals NHS Trust *Recruiting*
London, England, SE1 9RT
United Kingdom
Recruiting Peter Harper 44-20-7955-2933
Ipswich Hospital NHS Trust *Recruiting*
Ipswich, England, IP4 5PD
United Kingdom
Recruiting John Vay 44-014-7371-2233
Beatson Oncology Centre *Recruiting*
Glasgow, Scotland, G11 6NT
United Kingdom
Recruiting Paul Vasey 0141-211-2009
Nottingham City Hospital NHS Trust *Recruiting*
Nottingham, England, NG5 1PB
United Kingdom
Recruiting Michael Sokal 44-115-969-1169
Royal Devon and Exeter Hospital *Recruiting*
Exeter, England, EX2 5DW
United Kingdom
Recruiting A. Hong 01392-402118
Additional Information:
Study ID Numbers: CDR0000256314; EU-20115,MRC-TE22
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045045
Other Testicular Cancer Studies:
1. BMS-247550 in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors
2. Diagnostic Study of Patients With Stage I Testicular Cancer
3. Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors
4. Ribavirin With or Without Monoclonal Antibody Therapy in Treating Patients Who Develop RSV Pneumonia Following Peripheral Stem Cell Transplantation
5. High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
Related Studies:
Other Testicular Cancer Clinical Trials
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Positron Emission Tomography in Detecting Testicle Cancer
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