New Strategy for the Treatment of Vulvar Cancer
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|ClinicalTrials.gov Identifier: NCT02067052|
Recruitment Status : Recruiting
First Posted : February 20, 2014
Last Update Posted : January 17, 2018
Vulvar cancer is a rare disease that is treated with surgery, radiation and chemotherapy. When tumors are large (greater than 4 cm) or compromise the urethra (urine canal) and the anus, or when it is in the groin lymph nodes, surgery alone is not always able to be performed. In this circumstance, is necessary to add radiotherapy, chemotherapy or both .
So far it is not known the best sequence of treatment: surgery, chemotherapy or radiotherapy. The radical surgeries usually need long recovery term both in the region of the vulva and in the region of the groin lymph nodes. When it is performed, convalescence can delay other treatments, like radiotherapy and chemotherapy. On the other hand, the use of radiotherapy and chemotherapy as a first step treatment can result in a complete elimination of the disease in at least 30% of the cases or substantial reduction of its size, allowing less extensive surgery.
Investigators intend to use surgery, chemotherapy and radiotherapy in the treatment of vulvar cancer, but in a sequence that has not been studied, in order to increase benefits of these treatments, and reduce morbidity.
This study will be offered to patients who have disease of the vulva less than 4 cm (sentinel lymph node), or greater than 4 cm, or illness that compromises urethra and anus, or patients with disease in groin lymph nodes (glands).
- On the eve of the surgery, investigators will inject dextran-70 labeled with technetium-99 m. Only patients with tumors smaller than 4 cm will do this procedure.
- On the day of the surgery, the groin lymph nodes will be removed from the inguinal (groin) only. If lymph nodes are disease positive, the vulvectomy will not be performed at this time. Patients will be treated with radiation therapy with concomitant chemotherapy for approximately six weeks.
- At the end of treatment with chemotherapy and radiotherapy, investigators will perform a surgery to remove the remaining tumor in the vulva.
|Condition or disease||Intervention/treatment|
|Vulvar Neoplasm||Procedure: Surgery, radiotherapy and chemotherapy Procedure: Surgery|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||21 participants|
|Official Title:||New Strategy for the Treatment of Vulvar Cancer Employing Sentinel Scintigraphy, Surgery, Chemotherapy, and Radiotherapy|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||December 2018|
Advanced vulvar cancer
Patients with advanced-stage tumors.
Procedure: Surgery, radiotherapy and chemotherapy
Surgery: vulvectomy and lymphadenectomy Radiotherapy: 180 cGy / day per 5 days untill maximum dose 4500 - 5940 cGy Chemotherapy: vulvectomy, lymphadenectomy
Early-stage vulvar cancer
Patients with early-stage tumors
Vulvectomy & lymphadenectomy
- Patological response [ Time Frame: up to 24 months ]
The groin lymph nodes will be removed from the inguinal (groin) only. If investigators find disease in the lymph nodes, the vulvectomy will not be performed at this time, but patients will be treated with radiation therapy with concomitant chemotherapy for a period of approximately six weeks.
At the end of treatment with chemotherapy and radiotherapy, the investigators will perform a surgery to remove remaining tumour in the vulva followed by patological response evaluation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02067052
|Contact: Altamiro R Dias Jr||(11)email@example.com|
|Contact: Altamiro R Dias Jr||11)firstname.lastname@example.org|
|São Paulo, Brazil, 05409-001|
|Contact: Altamiro R Dias Jr (11)99112-8281 email@example.com|
|Principal Investigator: Altamiro R Dias Jr|
|Principal Investigator:||Altamiro R Dias Jr||University of Sao Paulo General Hospital|