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

Investigating Radiation Therapy with Investigational Medications for squamous cell carcinoma of the Vulva

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
  • Age: 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 19 Feb 2024. Study ID: 1302010703

This study investigates the effectiveness of using radiation therapy along with investigational medications in treating patients with a type of skin cancer called squamous cell carcinoma of the vulva. Squamous cell carcinoma is a cancer that begins in the flat cells lining the vulva, which is the outer part of the female genitals. This study focuses on cases where the cancer is locally advanced, meaning it has spread to nearby tissues but not to distant body parts.

Participants in the study will receive radiation therapy combined with investigational medications. Radiation therapy uses high-energy rays to kill cancer cells, while the investigational medications are substances being tested to see if they can improve treatment outcomes. One of the medications used in this study is a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.

  • Who can participate: Adults with locally advanced, previously untreated squamous cell carcinoma of the vulva may participate. Eligible candidates have T2 or T3 primary tumors that cannot be surgically removed by standard radical vulvectomy and must meet certain health criteria, including specific blood cell counts.
  • Study details: Participants will undergo radiation therapy and receive investigational medications. Some participants will receive a placebo, an inactive substance that looks like the investigational medicine but does not contain any medicine.

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