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
Recruiting
18 years - 100 years
Female
Phase
N/A
13 participants needed
1 Location
Brief description of study
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.
Detailed description of study
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 of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Squamous Cell Carcinoma of the Vulva,Squamous Cell Carcinoma,Squamous Cell,Carcinoma,Cancer,Vulva Cancer,Oncology
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Age: 18 years - 100 years
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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
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
04 Aug 2024.
Study ID: 1302010703
Pre-Screener
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