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A Phase II Trial of Radiation Therapy and Weekly Cisplatin Chemotherapy for the Treatment of Locally-Advanced Squamous Cell Carcinoma of the Vulva

Phase 2
Not Enrolling
Vulvar Cancer

Thank you

Trial Information

A Phase II Trial of Radiation Therapy and Weekly Cisplatin Chemotherapy for the Treatment of Locally-Advanced Squamous Cell Carcinoma of the Vulva


- 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

Inclusion Criteria


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete clinical and pathologic tumor response at completion of treatment

Safety Issue:


Principal Investigator

David H. Moore, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gynecologic Oncology of Indiana


United States: Federal Government

Study ID:




Start Date:

January 2005

Completion Date:

Related Keywords:

  • Vulvar Cancer
  • squamous cell carcinoma of the vulva
  • stage III vulvar cancer
  • stage IVB vulvar cancer
  • Carcinoma, Squamous Cell
  • Vulvar Neoplasms



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