AzTrials
AzTrials

Stage III Vulvar Cancer AJCC v7Phase 2NCT01595061

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

A Phase 2 study testing Cisplatin, Gemcitabine Hydrochloride and Intensity-Modulated Radiation Therapy in people with Stage III Vulvar Cancer AJCC v7 and Stage IIIA Vulvar Cancer AJCC v7, run by Gynecologic Oncology Group at 193 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Cisplatin, Gemcitabine Hydrochloride and Intensity-Modulated Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
193 sitesUnited States
Study dates
2 Jul 2012to 23 Sep 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 =< 1.5 times institutional upper limit of normal (ULN) OR calculated creatinine clearance >= 60 mL/min
  • Bilirubin =< 1.5 x ULN
Show all 12Show fewer
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN
  • Alkaline phosphatase =< 3 x ULN
  • Patients judged capable of tolerating a radical course of chemoradiation therapy
  • Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III protocol or Rare Tumor protocol for the same patient population
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients with a GOG performance status of 0, 1, or 2

Who cannot join

  • Patients with recurrent carcinoma of the vulva regardless of previous treatment
  • Patients who have received prior pelvic radiation or cytotoxic chemotherapy
  • Patients with vulvar melanomas or sarcomas
  • Patients with circumstances that will not permit completion of the study or the required follow-up
  • 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, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy

Trial locations and contacts

193 sites in 1 country.

193 sites in 1 country

United States193 sites

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

  • Jefferson Abington Hospital

    Abington, Pennsylvania, 19001

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • Women's Cancer Care Associates LLC

    Albany, New York, 12208

  • 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

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Woman's Hospital

    Baton Rouge, Louisiana, 70817

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Saint Charles Health System

    Bend, Oregon, 97701

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • 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

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • 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

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Carle on Vermilion

    Danville, Illinois, 61832

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Saint Elizabeth Medical Center South

    Edgewood, Kentucky, 41017

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Christiana Care - Union Hospital

    Elkton, Maryland, 21921

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • 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

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • Parkview Hospital Randallia

    Fort Wayne, Indiana, 46805

  • Parkview Regional Medical Center

    Fort Wayne, Indiana, 46845

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • 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

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • AdventHealth Hendersonville

    Hendersonville, North Carolina, 28792

  • Sudarshan K Sharma MD Limited-Gynecologic Oncology

    Hinsdale, Illinois, 60521

  • 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

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Capital Region Southwest Campus

    Jefferson City, Missouri, 65109

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Providence Regional Cancer System-Lacey

    Lacey, Washington, 98503

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89169

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • PeaceHealth Saint John Medical Center

    Longview, Washington, 98632

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83686

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

  • Ochsner Baptist Medical Center

    New Orleans, Louisiana, 70115

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • 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

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • 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

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Saint Charles Health System-Redmond

    Redmond, Oregon, 97756

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • 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

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • TidalHealth Nanticoke / Allen Cancer Center

    Seaford, Delaware, 19973

  • 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

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Providence Regional Cancer System-Shelton

    Shelton, Washington, 98584

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • 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

  • 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

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • 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

  • Southwest Illinois Health Services LLP

    Swansea, Illinois, 62226

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    Tulsa, Oklahoma, 74146

  • Saint Luke's Cancer Institute - Twin Falls

    Twin Falls, Idaho, 83301

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • The Carle Foundation Hospital

    Urbana, Illinois, 61801

  • PeaceHealth Southwest Medical Center

    Vancouver, Washington, 98664

  • MD Anderson Cancer Center at Cooper-Voorhees

    Voorhees Township, New Jersey, 08043

  • Providence Saint Mary Regional Cancer Center

    Walla Walla, Washington, 99362

  • UHHS-Westlake Medical Center

    Westlake, Ohio, 44145

  • Asplundh Cancer Pavilion

    Willow Grove, Pennsylvania, 19090

  • Christiana Care Health System-Wilmington Hospital

    Wilmington, Delaware, 19801

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Providence Regional Cancer System-Yelm

    Yelm, Washington, 98597

  • Rush-Copley Healthcare Center

    Yorkville, Illinois, 60560

Other trials in United States

About this study

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)

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the efficacy of cisplatin, gemcitabine (gemcitabine hydrochloride), and intensity-modulated radiation therapy (IMRT) in achieving a complete pathologic response when used for the primary treatment of locally-advanced squamous cell carcinoma of the vulva.

SECONDARY OBJECTIVES:

  1. To determine the efficacy of cisplatin, gemcitabine, and IMRT in achieving a complete clinical response when used for the primary treatment of locally-advanced squamous cell carcinoma of the vulva.

II. To determine the vulvar progression-free survival and groin progression-free survival in women treated with cisplatin, gemcitabine and IMRT for locally advanced vulvar carcinoma.

III. To determine the toxicity and surgical morbidity of the combined modality approach of cisplatin, gemcitabine and IMRT followed by reduced-scope surgery for the treatment of locally-advanced vulvar carcinoma.

OUTLINE:

Patients undergo IMRT 5 days a week for 6 weeks. Patients also receive gemcitabine hydrochloride intravenously (IV) over 30 minutes and cisplatin IV over 60 minutes weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after completion of chemoradiation patients undergo local core biopsy to confirm response or surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Being tested
Cisplatin, Gemcitabine Hydrochloride, Intensity-Modulated Radiation Therapy, Therapeutic Conventional Surgery
Medical subject headings
Vulvar Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • Gemcitabine HydrochlorideDrug

    Also called dFdCyd, Difluorodeoxycytidine Hydrochloride, FF 10832, FF-10832

    Given IV

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy

    Undergo IMRT

  • Therapeutic Conventional SurgeryProcedure or surgery

    Undergo local core biopsy or surgical excision

Study groups in NCT01595061
Study groupRoleWhat they receive
Treatment (IMRT, gemcitabine, cisplatin, surgery)ExperimentalPatients undergo IMRT 5 days a week for 6 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 60 minutes weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after completion of chemoradiation patients undergo local core biopsy to confirm response or surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes.
Receives: Drug: Cisplatin; Drug: Gemcitabine Hydrochloride; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Therapeutic Conventional Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Pathologic Response

    Percentage of participants with complete pathologic response. Complete pathologic response is defined as negative local core biopsy or FNA specimens following primary chemo-radiation therapy.

    Measured: 6 -8 weeks after completion of chemo-radiation

Secondary outcomes (3)

  1. Complete Clinical Response

    Percentage of participants with complete clinical response. Complete clinical response is defined as no clinical/radiographic evidence of primary disease (vulva or groin) following primary chemo-radiation therapy.

    Measured: 6-8 weeks after completion of chemo-radiation

  2. Adverse Events (Grade 3 or Higher) During Treatment Period

    Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.

    Measured: During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.

  3. Progression-free Survival (PFS)

    Estimate for probability of progression free survival by Kaplan-Meier method, where progression-free survival is defined as the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. PFS is censored in patients who are alive and have not progressed. Progression is assessed by RECIST 1.1

    Measured: From study entry to disease progression, death or date of last contact, whichever occurs first. The median for observed PFS was 26.2 month with a range from 1.5 months to 82.4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2012 (estimated)
  2. Study start2 Jul 2012
  3. Primary completion23 Sep 2020
  4. Study completion23 Sep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01595061
Sponsor's protocol ID
GOG-0279
Other IDs
NCI-2012-01964, CDR0000732793, GOG-0279, GOG-0279, U10CA180868, U10CA027469
Status last verified
Dec 2021
First submitted
8 May 2012
Last updated
29 Dec 2021
Data monitoring committee
Yes

Publications

  • Horowitz NS, Deng W, Peterson I, Mannel RS, Thompson S, Lokich E, Myers T, Hanjani P, O'Malley DM, Chung KY, Miller DS, Ueland FR, Dizon DS, Miller A, Mayadev JS, Leath CA 3rd, Monk BJ. Phase II Trial of Cisplatin, Gemcitabine, and Intensity-Modulated Radiation Therapy for Locally Advanced Vulvar Squamous Cell Carcinoma: NRG Oncology/GOG Study 279. J Clin Oncol. 2024 Jun 1;42(16):1914-1921. doi: 10.1200/JCO.23.02235. Epub 2024 Apr 4.

    PubMed 38574312

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin, Gemcitabine Hydrochloride and Intensity-Modulated Radiation Therapy in people with Stage III Vulvar Cancer AJCC v7 and Stage IIIA Vulvar Cancer AJCC v7, run by Gynecologic Oncology Group at 193 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 193 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Pathologic Response (time frame: 6 -8 weeks after completion of chemo-radiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01595061, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.

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