ClinicalTrials.gov record
Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva
ClinicalTrials.gov ID: NCT01595061
Public ClinicalTrials.gov record NCT01595061. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Trial Evaluating Cisplatin (NSC #119875) and Gemcitabine (NSC #613327) Concurrent With Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva (NCT #01595061)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01595061
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 57 participants
Conditions and interventions
Conditions
Interventions
- Cisplatin Drug
- Gemcitabine Hydrochloride Drug
- Intensity-Modulated Radiation Therapy Radiation
- Therapeutic Conventional Surgery Procedure
Drug · Radiation · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 1, 2012
- Primary completion
- Sep 22, 2020
- Completion
- Sep 22, 2022
- Last update posted
- Dec 28, 2021
2012 – 2022
United States locations
- U.S. sites
- 193
- U.S. states
- 34
- U.S. cities
- 133
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | — |
| Anchorage Associates in Radiation Medicine | Anchorage | Alaska | 98508 | — |
| Anchorage Radiation Therapy Center | Anchorage | Alaska | 99504 | — |
| Alaska Breast Care and Surgery LLC | Anchorage | Alaska | 99508 | — |
| Alaska Oncology and Hematology LLC | Anchorage | Alaska | 99508 | — |
| Alaska Women's Cancer Care | Anchorage | Alaska | 99508 | — |
| Anchorage Oncology Centre | Anchorage | Alaska | 99508 | — |
| Katmai Oncology Group | Anchorage | Alaska | 99508 | — |
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | — |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | 91505 | — |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| The Hospital of Central Connecticut | New Britain | Connecticut | 06050 | — |
| Beebe Medical Center | Lewes | Delaware | 19958 | — |
| Christiana Gynecologic Oncology LLC | Newark | Delaware | 19713 | — |
| Delaware Clinical and Laboratory Physicians PA | Newark | Delaware | 19713 | — |
| Helen F Graham Cancer Center | Newark | Delaware | 19713 | — |
| Medical Oncology Hematology Consultants PA | Newark | Delaware | 19713 | — |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | — |
| Beebe Health Campus | Rehoboth Beach | Delaware | 19971 | — |
| TidalHealth Nanticoke / Allen Cancer Center | Seaford | Delaware | 19973 | — |
| Christiana Care Health System-Wilmington Hospital | Wilmington | Delaware | 19801 | — |
| Augusta University Medical Center | Augusta | Georgia | 30912 | — |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia | 31405 | — |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | — |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | — |
| The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii | 96817 | — |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | — |
| The Cancer Center of Hawaii-Pali Momi | ‘Aiea | Hawaii | 96701 | — |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | — |
| Saint Luke's Cancer Institute - Fruitland | Fruitland | Idaho | 83619 | — |
| Saint Luke's Cancer Institute - Meridian | Meridian | Idaho | 83642 | — |
| Saint Luke's Cancer Institute - Nampa | Nampa | Idaho | 83686 | — |
| Saint Luke's Cancer Institute - Twin Falls | Twin Falls | Idaho | 83301 | — |
| Rush - Copley Medical Center | Aurora | Illinois | 60504 | — |
| Saint Joseph Medical Center | Bloomington | Illinois | 61701 | — |
| Illinois CancerCare-Bloomington | Bloomington | Illinois | 61704 | — |
| Illinois CancerCare-Canton | Canton | Illinois | 61520 | — |
| Memorial Hospital of Carbondale | Carbondale | Illinois | 62902 | — |
| SIH Cancer Institute | Carterville | Illinois | 62918 | — |
| Illinois CancerCare-Carthage | Carthage | Illinois | 62321 | — |
| Centralia Oncology Clinic | Centralia | Illinois | 62801 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Carle on Vermilion | Danville | Illinois | 61832 | — |
| Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | 62526 | — |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | — |
| Carle Physician Group-Effingham | Effingham | Illinois | 62401 | — |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | — |
| Illinois CancerCare-Eureka | Eureka | Illinois | 61530 | — |
| Illinois CancerCare-Galesburg | Galesburg | Illinois | 61401 | — |
| Western Illinois Cancer Treatment Center | Galesburg | Illinois | 61401 | — |
| Northwestern Medicine Cancer Center Delnor | Geneva | Illinois | 60134 | — |
| Sudarshan K Sharma MD Limited-Gynecologic Oncology | Hinsdale | Illinois | 60521 | — |
| Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | 61443 | — |
| Illinois CancerCare-Macomb | Macomb | Illinois | 61455 | — |
| Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | 61938 | — |
| Good Samaritan Regional Health Center | Mount Vernon | Illinois | 62864 | — |
| UC Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois | 60451 | — |
| Cancer Care Center of O'Fallon | O'Fallon | Illinois | 62269 | — |
| Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | 61350 | — |
| Radiation Oncology of Northern Illinois | Ottawa | Illinois | 61350 | — |
| Illinois CancerCare-Pekin | Pekin | Illinois | 61554 | — |
| OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center | Pekin | Illinois | 61554 | — |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | — |
| OSF Saint Francis Radiation Oncology at Peoria Cancer Center | Peoria | Illinois | 61615 | — |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | — |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | — |
| Illinois CancerCare-Peru | Peru | Illinois | 61354 | — |
| Valley Radiation Oncology | Peru | Illinois | 61354 | — |
| Illinois CancerCare-Princeton | Princeton | Illinois | 61356 | — |
| Central Illinois Hematology Oncology Center | Springfield | Illinois | 62702 | — |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | — |
| Springfield Clinic | Springfield | Illinois | 62702 | — |
| Memorial Medical Center | Springfield | Illinois | 62781 | — |
| Southwest Illinois Health Services LLP | Swansea | Illinois | 62226 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| The Carle Foundation Hospital | Urbana | Illinois | 61801 | — |
| Rush-Copley Healthcare Center | Yorkville | Illinois | 60560 | — |
| Parkview Hospital Randallia | Fort Wayne | Indiana | 46805 | — |
| Parkview Regional Medical Center | Fort Wayne | Indiana | 46845 | — |
| Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| Saint Elizabeth Medical Center South | Edgewood | Kentucky | 41017 | — |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| Woman's Hospital | Baton Rouge | Louisiana | 70817 | — |
| Ochsner Baptist Medical Center | New Orleans | Louisiana | 70115 | — |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | — |
| Christiana Care - Union Hospital | Elkton | Maryland | 21921 | — |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | — |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Weisberg Cancer Treatment Center | Farmington Hills | Michigan | 48334 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | — |
| Borgess Medical Center | Kalamazoo | Michigan | 49048 | — |
| Sanford Joe Lueken Cancer Center | Bemidji | Minnesota | 56601 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Parkland Health Center-Bonne Terre | Bonne Terre | Missouri | 63628 | — |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | — |
| Southeast Cancer Center | Cape Girardeau | Missouri | 63703 | — |
| Capital Region Southwest Campus | Jefferson City | Missouri | 65109 | — |
| Mercy Hospital Joplin | Joplin | Missouri | 64804 | — |
| Delbert Day Cancer Institute at PCRMC | Rolla | Missouri | 65401 | — |
| Mercy Clinic-Rolla-Cancer and Hematology | Rolla | Missouri | 65401 | — |
| Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri | 63670 | — |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | — |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | — |
| Saint Louis Cancer and Breast Institute-South City | St Louis | Missouri | 63109 | — |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | — |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | — |
| Missouri Baptist Sullivan Hospital | Sullivan | Missouri | 63080 | — |
| Missouri Baptist Outpatient Center-Sunset Hills | Sunset Hills | Missouri | 63127 | — |
| Saint Patrick Hospital - Community Hospital | Missoula | Montana | 59802 | — |
| Women's Cancer Center of Nevada | Las Vegas | Nevada | 89169 | — |
| Cooper Hospital University Medical Center | Camden | New Jersey | 08103 | — |
| MD Anderson Cancer Center at Cooper-Voorhees | Voorhees Township | New Jersey | 08043 | — |
| Women's Cancer Care Associates LLC | Albany | New York | 12208 | — |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | — |
| AdventHealth Hendersonville | Hendersonville | North Carolina | 28792 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | 58501 | — |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | — |
| Sanford Clinic North-Fargo | Fargo | North Dakota | 58122 | — |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58122 | — |
| Summa Health System - Akron Campus | Akron | Ohio | 44304 | — |
| UHHS-Chagrin Highlands Medical Center | Beachwood | Ohio | 44122 | — |
| University of Cincinnati Cancer Center-UC Medical Center | Cincinnati | Ohio | 45219 | — |
| Case Western Reserve University | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | 44111 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Grandview Hospital | Dayton | Ohio | 45405 | — |
| Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | 44124 | — |
| UHHS-Westlake Medical Center | Westlake | Ohio | 44145 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Oklahoma Cancer Specialists and Research Institute-Tulsa | Tulsa | Oklahoma | 74146 | — |
| Saint Charles Health System | Bend | Oregon | 97701 | — |
| Clackamas Radiation Oncology Center | Clackamas | Oregon | 97015 | — |
| Providence Cancer Institute Clackamas Clinic | Clackamas | Oregon | 97015 | — |
| Bay Area Hospital | Coos Bay | Oregon | 97420 | — |
| Providence Newberg Medical Center | Newberg | Oregon | 97132 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | — |
| Saint Charles Health System-Redmond | Redmond | Oregon | 97756 | — |
| Jefferson Abington Hospital | Abington | Pennsylvania | 19001 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | — |
| Asplundh Cancer Pavilion | Willow Grove | Pennsylvania | 19090 | — |
| Women and Infants Hospital | Providence | Rhode Island | 02905 | — |
| AnMed Health Cancer Center | Anderson | South Carolina | 29621 | — |
| Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina | 29316 | — |
| Prisma Health Cancer Institute - Easley | Easley | South Carolina | 29640 | — |
| Gibbs Cancer Center-Gaffney | Gaffney | South Carolina | 29341 | — |
| Greenville Health System Cancer Institute-Andrews | Greenville | South Carolina | 29601 | — |
| Saint Francis Hospital | Greenville | South Carolina | 29601 | — |
| Prisma Health Cancer Institute - Butternut | Greenville | South Carolina | 29605 | — |
| Prisma Health Cancer Institute - Faris | Greenville | South Carolina | 29605 | — |
| Prisma Health Greenville Memorial Hospital | Greenville | South Carolina | 29605 | — |
| Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | 29615 | — |
| Prisma Health Cancer Institute - Greer | Greer | South Carolina | 29650 | — |
| Gibbs Cancer Center-Pelham | Greer | South Carolina | 29651 | — |
| Prisma Health Cancer Institute - Seneca | Seneca | South Carolina | 29672 | — |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | — |
| Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota | 57104 | — |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | — |
| Parkland Memorial Hospital | Dallas | Texas | 75235 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| Memorial Hermann Texas Medical Center | Houston | Texas | 77030 | — |
| Providence Regional Cancer System-Aberdeen | Aberdeen | Washington | 98520 | — |
| PeaceHealth Saint Joseph Medical Center | Bellingham | Washington | 98225 | — |
| Providence Regional Cancer System-Centralia | Centralia | Washington | 98531 | — |
| Swedish Cancer Institute-Edmonds | Edmonds | Washington | 98026 | — |
| Providence Regional Cancer Partnership | Everett | Washington | 98201 | — |
| Swedish Cancer Institute-Issaquah | Issaquah | Washington | 98029 | — |
| Kadlec Clinic Hematology and Oncology | Kennewick | Washington | 99336 | — |
| Providence Regional Cancer System-Lacey | Lacey | Washington | 98503 | — |
| PeaceHealth Saint John Medical Center | Longview | Washington | 98632 | — |
| Pacific Gynecology Specialists | Seattle | Washington | 98104 | — |
| Swedish Medical Center-Ballard Campus | Seattle | Washington | 98107 | — |
| Kaiser Permanente Washington | Seattle | Washington | 98112 | — |
| Swedish Medical Center-First Hill | Seattle | Washington | 98122-4307 | — |
| Swedish Medical Center-Cherry Hill | Seattle | Washington | 98122-5711 | — |
| PeaceHealth United General Medical Center | Sedro-Woolley | Washington | 98284 | — |
| Providence Regional Cancer System-Shelton | Shelton | Washington | 98584 | — |
| MultiCare Deaconess Cancer and Blood Specialty Center - Downtown | Spokane | Washington | 99204 | — |
| MultiCare Deaconess Cancer and Blood Specialty Center - North | Spokane | Washington | 99218 | — |
| MultiCare Deaconess Cancer and Blood Specialty Center - Valley | Spokane Valley | Washington | 99216 | — |
| PeaceHealth Southwest Medical Center | Vancouver | Washington | 98664 | — |
| Providence Saint Mary Regional Cancer Center | Walla Walla | Washington | 99362 | — |
| Providence Regional Cancer System-Yelm | Yelm | Washington | 98597 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01595061, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 28, 2021 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01595061 live on ClinicalTrials.gov.