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Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 11, 2003
Last Update Posted: September 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

RATIONALE: Drugs used in chemotherapy such as cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery.

PURPOSE: This phase II trial is studying how well giving radiation therapy together with cisplatin followed by surgery works in treating patients with locally advanced cancer of the vulva.

Condition Intervention Phase
Vulvar Cancer Drug: cisplatin Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Radiation Therapy and Weekly Cisplatin Chemotherapy for the Treatment of Locally-Advanced Squamous Cell Carcinoma of the Vulva

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Complete clinical and pathologic tumor response at completion of treatment

Secondary Outcome Measures:
  • Toxicity weekly during treatment then every 3 months after treatment

Estimated Enrollment: 58
Study Start Date: January 2005
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:


  • Determine the efficacy of radiotherapy and cisplatin, in terms of achieving a complete clinical and pathological response, in patients with locally advanced squamous cell carcinoma of the vulva that is not amenable to standard radical vulvectomy.
  • Determine the toxicity of this regimen followed by surgery in these patients.

OUTLINE: This is a multicenter study.

Patients undergo radiotherapy daily on days 1-5 and receive concurrent cisplatin IV over 30 minutes on day 1. Treatment repeats weekly for approximately 6.5 weeks (a total of 32 fractions of radiotherapy) in the absence of unacceptable toxicity.

Six to eight weeks after the completion of chemoradiotherapy, patients with a complete clinical response may undergo incisional biopsy of the primary tumor and bilateral inguinal/femoral nodes (if the groin nodes were initially unresectable). Patients with microscopic or gross resectable residual disease may then undergo radical resection of the residual tumor. Patients with unresectable disease after the completion of chemoradiotherapy receive additional radiotherapy with 1-2 courses of concurrent cisplatin.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 25-58 patients will be accrued for this study within 1.8-2.3 years.


Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Diagnosis of locally advanced squamous cell carcinoma of the vulva

    • T3 or T4 (N0-3, M0)
  • Not amenable to surgical resection by standard radical vulvectomy
  • Previously untreated disease
  • No recurrent disease
  • No vulvar melanoma or sarcoma



  • Any age

Performance status

  • GOG 0-3

Life expectancy

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 times normal
  • Alkaline phosphatase no greater than 3 times normal
  • SGOT no greater than 3 times normal


  • Creatinine no greater than 2.0 mg/dL


  • No gastrointestinal bleeding
  • No severe gastrointestinal symptoms


  • Capable of tolerating a radical course of chemoradiotherapy
  • No septicemia
  • No severe infection
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No circumstance that would preclude study completion or follow-up


Biologic therapy

  • Not specified


  • No prior cytotoxic chemotherapy

Endocrine therapy

  • Not specified


  • No prior pelvic radiotherapy
  • No concurrent boost brachytherapy


  • Not specified


  • No prior anticancer therapy that would contraindicate study therapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068406

  Show 113 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: David H. Moore, MD Gynecologic Oncology of Indiana
OverallOfficial: Wui-jin Koh, MD Fred Hutchinson Cancer Research Center
  More Information

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00068406     History of Changes
Other Study ID Numbers: CDR0000322259
First Submitted: September 10, 2003
First Posted: September 11, 2003
Last Update Posted: September 5, 2012
Last Verified: September 2009

Keywords provided by National Cancer Institute (NCI):
squamous cell carcinoma of the vulva
stage III vulvar cancer
stage IVB vulvar cancer

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

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