MedTrace Logo

Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva

NCT01595061 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2021-12-29

Study results available
· View outcomes & findings →

Summary

This phase II trial studies how well radiation therapy works when given with gemcitabine hydrochloride and cisplatin work in treating patients with squamous cell cancer of the vulva that has spread from where it started to nearby tissue or lymph nodes. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving radiation therapy together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.

Conditions

  • Stage III Vulvar Cancer AJCC v7
  • Stage IIIA Vulvar Cancer AJCC v7
  • Stage IIIB Vulvar Cancer AJCC v7
  • Stage IIIC Vulvar Cancer AJCC v7
  • Stage IVA Vulvar Cancer AJCC v7
  • Vulvar Squamous Cell Carcinoma

Interventions

DRUG

Cisplatin

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

PROCEDURE

Therapeutic Conventional Surgery

Undergo local core biopsy or surgical excision

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Gynecologic Oncology Group

    lead NETWORK

Principal Investigators

  • Neil S Horowitz · NRG Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-02
Primary Completion
2020-09-23
Completion
2022-09-23

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01595061 on ClinicalTrials.gov