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A Study Of 18 FDG PET In The Prediction Of Relapse In Patients With A Clinical Stage I Non-Seminomatous Germ Cell Tumor


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Testicular Germ Cell Tumor

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Trial Information

A Study Of 18 FDG PET In The Prediction Of Relapse In Patients With A Clinical Stage I Non-Seminomatous Germ Cell Tumor


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.

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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Diagnostic

Principal Investigator

Robert A. Huddart, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Royal Marsden NHS Foundation Trust

Authority:

United States: Federal Government

Study ID:

CDR0000256314

NCT ID:

NCT00045045

Start Date:

May 2002

Completion Date:

Related Keywords:

  • Testicular Germ Cell Tumor
  • 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

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