Observation in Patients With Early-Stage Vulvar Cancer Following Surgery and/or Radiation Therapy

Overview

Información sobre este estudio

This observational trial studies how well surgery to remove the tumor and lymph nodes, and/or radiation therapy work in treating patients with early-stage vulvar cancer. Observation is closely monitoring a patient's condition and not giving treatment until symptoms appear or change. Observation may help doctors see how effective surgery and/or radiation therapy are in treating vulvar cancer.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria: - Patients with squamous cell carcinoma, depth of invasion > 1 mm - Patients with T1 or T2 tumors (International Federation of Gynecology and Obstetrics[FIGO] staging), tumors < 4 cm, and/or not encroaching in urethra, vagina, or anus with clinically negative inguinofemoral lymph nodes - Localization and size of the tumor are such that perilesional injection of the tracers at three or four sites is possible - Preoperative imaging do not show enlarged (< 1.5 cm) suspicious nodes - No inoperable tumors and tumors with diameter > 4 cm - No patients with inguinofemoral lymph nodes, at palpation clinically suspect for metastases, at radiology enlarged (> 1.5 cm)/suspicious groin nodes, and with cytologically proven inguinofemoral lymph node metastases - No patients with multifocal tumors - No concurrent intensity-modulated radiation therapy - Patients who are currently on an investigational drug for the treatment of vulvar cancer are excluded from participation in this trial

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Jamie Bakkum-Gamez, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Mankato, Minn.

Investigador principal de Mayo Clinic

Jamie Bakkum-Gamez, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Eau Claire, Wis.

Investigador principal de Mayo Clinic

Jamie Bakkum-Gamez, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Albert Lea, Minn.

Investigador principal de Mayo Clinic

Jamie Bakkum-Gamez, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

La Crosse, Wis.

Investigador principal de Mayo Clinic

Jamie Bakkum-Gamez, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publicaciones

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CLS-20177812

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