Trial record 5 of 23 for:    Open Studies | "Vulvar Neoplasms"

New Strategy for the Treatment of Vulvar Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Instituto do Cancer do Estado de São Paulo
Sponsor:
Collaborator:
University of Sao Paulo General Hospital
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier:
NCT02067052
First received: August 30, 2013
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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

Condition Intervention
Vulvar Neoplasm
Procedure: Surgery, radiotherapy and chemotherapy
Procedure: Surgery

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: New Strategy for the Treatment of Vulvar Cancer Employing Sentinel Scintigraphy, Surgery, Chemotherapy, and Radiotherapy

Resource links provided by NLM:


Further study details as provided by Instituto do Cancer do Estado de São Paulo:

Primary Outcome Measures:
  • Patological response [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 21
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Procedure: Surgery
Vulvectomy & lymphadenectomy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02067052

Contacts
Contact: Altamiro R Dias Jr (11)99112-8281 altamirodias@terra.com.br
Contact: Altamiro R Dias Jr 11)99112-8281 altamirodias@terra.com.br

Locations
Brazil
USPauloGH Recruiting
São Paulo, Brazil, 05409-001
Contact: Altamiro R Dias Jr    (11)99112-8281    altamirodias@terra.com.br   
Principal Investigator: Altamiro R Dias Jr         
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Altamiro R Dias Jr University of Sao Paulo General Hospital
  More Information

No publications provided

Responsible Party: Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT02067052     History of Changes
Other Study ID Numbers: Vulvar protocol- Dr. Altamiro
Study First Received: August 30, 2013
Last Updated: February 18, 2014
Health Authority: Brazil: Associação Fundo de Incentivo à Pesquisa
Brazil: National Committee of Ethics in Research

Keywords provided by Instituto do Cancer do Estado de São Paulo:
Vulvar neoplasm
sentinel nodes
chemotherapy
radiotherapy

Additional relevant MeSH terms:
Neoplasms
Vulvar Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Vulvar Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 22, 2014