Positron Emission Tomography in Detecting Testicle Cancer
A Study Of 18 FDG PET In The Prediction Of Relapse In Patients With A Clinical Stage I Non-Seminomatous Germ Cell Tumor
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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England
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Exeter, England, Reino Unido, EX2 5DW
- Royal Devon and Exeter Hospital
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Ipswich, England, Reino Unido, IP4 5PD
- Ipswich Hospital NHS Trust
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London, England, Reino Unido, SE1 9RT
- Guy's and St. Thomas' Hospitals NHS Foundation Trust
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London, England, Reino Unido, WIT 3AA
- Meyerstein Institute of Oncology at University College of London Hospitals
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Nottingham, England, Reino Unido, NG5 1PB
- Nottingham City Hospital NHS Trust
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Southampton, England, Reino Unido, 5O14OYG
- Royal South Hants Hospital
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Sutton, England, Reino Unido, SM2 5PT
- Royal Marsden NHS Foundation Trust - Surrey
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Scotland
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Glasgow, Scotland, Reino Unido, G11 6NT
- Beatson Oncology Centre
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: No aleatorizado
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Robert A. Huddart, MD, Royal Marsden NHS Foundation Trust
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- teratoma testicular
- carcinoma embrionario testicular
- coriocarcinoma testicular
- tumor del saco vitelino testicular
- Carcinoma y teratoma embrionario testicular
- Carcinoma embrionario testicular y teratoma con seminoma
- carcinoma embrionario testicular y tumor del saco vitelino
- carcinoma embrionario testicular y tumor del saco vitelino con seminoma
- carcinoma embrionario testicular y seminoma
- Tumor testicular del saco vitelino y teratoma
- tumor del saco vitelino testicular y teratoma con seminoma
- coriocarcinoma testicular y tumor del saco vitelino
- coriocarcinoma testicular y carcinoma embrionario
- coriocarcinoma y teratoma testicular
- coriocarcinoma y seminoma testicular
- Tumor testicular maligno de células germinativas en estadio I
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CDR0000256314
- MRC-TE22
- EU-20115
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