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

J
Jeanne Schilder, MD

Primary Investigator

Overview

This phase II trial studies how well giving radiation therapy together with gemcitabine hydrochloride and cisplatin work in treating patients with locally advanced squamous cell carcinoma of the vulva.

Description

This phase II trial studies how well giving radiation therapy together with gemcitabine hydrochloride and cisplatin work in treating patients with locally advanced squamous cell carcinoma of the vulva.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Vulva Cancer
  • Age: Between 18 Years - 100 Years
  • Gender: Female

Inclusion Criteria
Patients with locally advanced, previously untreated squamous cell carcinoma of the vulva
Patients with T2 or T3 primary tumors (N0-3, M0) not amenable to surgical resection by standard radical vulvectomy
Absolute neutrophil count (ANC) >= 1,500/mcl
Platelets >= 100,000/mcl
Creatinine =
Exclusion Criteria
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

Updated on 20 Nov 2022. Study ID: 1302010703

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

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