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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jamie Bakkum-Gamez, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Mankato, Minn.

Mayo Clinic principal investigator

Jamie Bakkum-Gamez, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Eau Claire, Wis.

Mayo Clinic principal investigator

Jamie Bakkum-Gamez, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Albert Lea, Minn.

Mayo Clinic principal investigator

Jamie Bakkum-Gamez, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

La Crosse, Wis.

Mayo Clinic principal investigator

Jamie Bakkum-Gamez, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20177812

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