New Strategy for the Treatment of Vulvar Cancer

NCT02067052 | Unknown

• 1 other identifier: NP 245/12
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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).

1. 1.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.
2. 2.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.
3. 3.At the end of treatment with chemotherapy and radiotherapy, investigators will perform a surgery to remove the remaining tumor in the vulva.

Conditions

Vulvar Neoplasm

Keywords

Vulvar neoplasm; sentinel nodes; chemotherapy; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Patological response

  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.

  up to 24 months

Secondary Outcomes (1)

• Inguinal lymphadenectomy-derived outcomes

  up to 12 months

Study Arms (2)

Advanced vulvar cancer

Patients with advanced-stage tumors.

Procedure: Surgery, radiotherapy and chemotherapy

Early-stage vulvar cancer

Patients with early-stage tumors

Procedure: Surgery

Interventions

Surgery, radiotherapy and chemotherapy PROCEDURE

Surgery: vulvectomy and lymphadenectomy Radiotherapy: 180 cGy / day per 5 days untill maximum dose 4500 - 5940 cGy Chemotherapy: vulvectomy, lymphadenectomy

Advanced vulvar cancer

Surgery PROCEDURE

Vulvectomy \& lymphadenectomy

Early-stage vulvar cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Twenty one consecutive patients with a diagnosis of vulvar carcinoma (early and advanced stages) will be studied. All patients with tumors up to 4 cm in greatest diameter, uncompromised urethra or anus, and lymph nodes smaller than 15 mm in greatest diameter in scan images will be considered early-stage cases. Any other cases will be deemed advanced.

You may qualify if:

• Patients with histological diagnosis of squamous cell carcinoma of the vulva;
• Performance status 0-3 (ECOG);
• Adequate bone marrow function, liver and kidney;

You may not qualify if:

• \- Patients with a history of treatment of other invasive cancers in the last 5 years

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead
• University of Sao Paulo General Hospital: collaborator

Study Sites (1)

USPauloGH

São Paulo, 05409-001, Brazil

Location

Related Publications (1)

• Dias-Jr AR, Soares-Jr JM, de Faria MBS, Genta MLND, Carvalho JP, Baracat EC. Secondary healing strategy for difficult wound closure in invasive vulvar cancer: a pilot case-control study. Clinics (Sao Paulo). 2019;74:e1218. doi: 10.6061/clinics/2019/e1218. Epub 2019 Sep 2.

  PMID: 31482981 DERIVED

MeSH Terms

Conditions

Vulvar Neoplasms

Interventions

Surgical Procedures, Operative; Radiotherapy; Drug Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Altamiro R Dias Jr

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2013
• First Posted: February 20, 2014
• Study Start: July 1, 2012
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2022
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

BR (1)