Clinical trialNCT01595061UnknownPhase 2Interventional

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

SponsorGynecologic Oncology GroupEnrollment57Stage III Vulvar Cancer AJCC v7Stage IIIA Vulvar Cancer AJCC v7Stage IIIB Vulvar Cancer AJCC v7Stage IIIC Vulvar Cancer AJCC v7Stage IVA Vulvar Cancer AJCC v7Vulvar Squamous Cell Carcinoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Neil S Horowitz
NRG Oncology
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

193 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Alaska Breast Care and Surgery Llc
Anchorage, Alaska, United States
Alaska Oncology and Hematology Llc
Anchorage, Alaska, United States
Alaska Women'S Cancer Care
Anchorage, Alaska, United States
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
Anchorage Oncology Centre
Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Providence Saint Joseph Medical Center/disney Family Cancer Center
Burbank, California, United States
Uc Irvine Health/chao Family Comprehensive Cancer Center
Orange, California, United States
Hartford Hospital
Hartford, Connecticut, United States
the Hospital of Central Connecticut
New Britain, Connecticut, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Christiana Gynecologic Oncology Llc
Newark, Delaware, United States
Delaware Clinical and Laboratory Physicians Pa
Newark, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants Pa
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Tidalhealth Nanticoke / Allen Cancer Center
Seaford, Delaware, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States
Augusta University Medical Center
Augusta, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph'S/candler
Savannah, Georgia, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Queen'S Medical Center
Honolulu, Hawaii, United States
the Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
the Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, United States
Saint Luke'S Cancer Institute - Boise
Boise, Idaho, United States
Saint Luke'S Cancer Institute - Fruitland
Fruitland, Idaho, United States
Saint Luke'S Cancer Institute - Meridian
Meridian, Idaho, United States
Saint Luke'S Cancer Institute - Nampa
Nampa, Idaho, United States
Saint Luke'S Cancer Institute - Twin Falls
Twin Falls, Idaho, United States
Rush - Copley Medical Center
Aurora, Illinois, United States
Illinois Cancercare-Bloomington
Bloomington, Illinois, United States
Saint Joseph Medical Center
Bloomington, Illinois, United States
Illinois Cancercare-Canton
Canton, Illinois, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, United States
Sih Cancer Institute
Carterville, Illinois, United States

153 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cisplatin →Gemcitabine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 2 Jul 2012
Primary completion: 23 Sept 2020
Completion: 23 Sept 2022
Last update posted: 29 Dec 2021
Registered enrollment: 57
Registry id: NCT01595061

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.