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A Phase II Trial Evaluating Cisplatin (NSC #119875) and Gemcitabine (NSC #613327) Concurrent With Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva

Phase 2
18 Years
Open (Enrolling)
Vulvar Cancer

Thank you

Trial Information

A Phase II Trial Evaluating Cisplatin (NSC #119875) and Gemcitabine (NSC #613327) Concurrent With Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva



- To determine the efficacy of cisplatin, gemcitabine hydrochloride (gemcitabine), and
intensity-modulated radiation therapy (IMRT) in achieving a complete pathologic
response when used for the primary treatment of locally advanced squamous cell
carcinoma of the vulva.


- To determine the efficacy of cisplatin, gemcitabine, and IMRT in achieving a complete
clinical response when used for the primary treatment of locally advanced squamous cell
carcinoma of the vulva.

- To determine the vulvar progression-free survival and groin progression-free survival
of women treated with cisplatin, gemcitabine, and IMRT for locally advanced vulvar

- To determine the toxicity and surgical morbidity of the combined-modality approach of
cisplatin, gemcitabine, and IMRT followed by reduced-scope surgery for the treatment of
locally advanced vulvar carcinoma.

OUTLINE: This is a multicenter study.

Patients undergo intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks.
Patients also receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 60
minutes weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.

Within 6-8 weeks after completion of chemoradiation patients undergo local core biopsy to
confirm response or surgical excision of gross residual disease in the vulva and/or
inguinal-femoral lymph nodes.

After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria


- Patients with locally advanced, previously untreated squamous cell carcinoma of the

- Patients with T2 or T3 primary tumors (N0-3, M0) not amenable to surgical resection
by standard radical vulvectomy

- Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG)
protocol, if one exists; in general, this would refer to any active GOG Phase III
protocol or Rare Tumor protocol for the same patient population

- No patients with recurrent carcinoma of the vulva regardless of previous treatment

- No patients with vulvar melanomas or sarcomas


- Absolute neutrophil count (ANC) ≥ 1,500/mcl

- Platelets ≥ 100,000/mcl

- Creatinine ≤ 1.5 times institutional upper limit of normal (ULN) OR calculated
creatinine clearance ≥ 60 mL/min

- Bilirubin ≤ 1.5 times ULN

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 times ULN

- Alkaline phosphatase ≤ 3 times ULN

- Patients judged capable of tolerating a radical course of chemoradiation therapy

- Patients must have signed an approved informed consent and authorization permitting
release of personal health information

- Patients with a GOG performance status of 0, 1, or 2

- No patients with circumstances that will not permit completion of the study or the
required follow-up

- No patients with evidence of active septicemia, severe infection, gastrointestinal
bleeding, or severe gastrointestinal symptoms requiring medical or surgical therapy

- Patients with a history of other invasive malignancies, with the exception of
non-melanoma skin cancer, are excluded if there is any evidence of other malignancy
being present within the last five years


- No patients who have received prior pelvic radiation or cytotoxic chemotherapy

- Patients are excluded if their previous cancer treatment contraindicates this
protocol therapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete pathologic response (pCR) evaluated as the frequency of complete clinical and pathologic response after primary therapy

Safety Issue:


Principal Investigator

Neil S. Horowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber/Brigham and Women's Cancer Center


United States: National Cancer Institutie

Study ID:




Start Date:

August 2012

Completion Date:

Related Keywords:

  • Vulvar Cancer
  • squamous cell carcinoma of the vulva
  • stage IIIA vulvar cancer
  • stage IIIB vulvar cancer
  • stage IIIC vulvar cancer
  • stage IVA vulvar cancer
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Vulvar Neoplasms



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