National Cancer Institute National Cancer Institute
U.S. National Institutes of Health National Cancer Institute
Diagnostic Study of Fludeoxyglucose F 18 Positron Emission Tomography in the Prediction of Relapse in Patients With High-Risk Stage I Non-Seminomatous or Mixed Seminoma/Non-Seminomatous Germ Cell Tumor of the Testis
Last Modified: 7/26/2007     First Published: 9/1/2002  

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Positron Emission Tomography in Detecting Testicle Cancer

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedDiagnosticClosedAny ageOtherMRC-TE22
EU-20115, NCT00045045

Objectives

  1. 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.

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


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

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

Expected Enrollment

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

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

Published Results

Huddart RA, O'Doherty MJ, Padhani A, et al.: 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 25 (21): 3090-5, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Institute of Cancer Research - London

Robert Huddart, MD, Protocol chair
Ph: 44-20-8661-3457
Email: robert.huddart@icr.ac.uk

Registry Information
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
Trial Start Date 2002-05-27
Registered in ClinicalTrials.gov NCT00045045 1
Date Submitted to PDQ 2002-06-19
Information Last Verified 2002-09-30

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.



Table of Links

1http://clinicaltrials.gov/ct/show/NCT00045045