Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva - Full Text View

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006096

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy combined with chemotherapy kills more tumor cells than radiation therapy alone in treating cancer of the vulva.

PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy with or without cisplatin in treating patients who have stage I, stage II, or stage III cancer of the vulva.

Condition	Intervention	Phase
Vulvar Cancer	Drug: cisplatin Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Randomized Study of Adjuvant Radiation Treatment Versus Radiation and Chemotherapy in Patients With Vulvar Cancer and Involved Nodes

Resource links provided by NLM:

MedlinePlus related topics: Cancer Vulvar Cancer

Drug Information available for: Cisplatin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

March 2001

Detailed Description:

OBJECTIVES:

Compare the recurrence-free interval and survival in patients with stage I, II, III, or IVA squamous cell carcinoma of the vulva with involved inguinal lymph nodes treated with adjuvant radiotherapy with or without cisplatin.
Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to primary surgical resection (yes vs no) and node status (N1 vs N2). Patients are randomized to one of two treatment arms.

Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks.
Arm II: Patients undergo radiotherapy as in arm I. Patients also receive cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study within 4.5 years.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed stage I, II, III, or IVA squamous cell carcinoma of the vulva amenable to curative treatment with surgery, radiotherapy, or both
- At least 1 positive inguinal and/or femoral lymph node
- No inoperable (fixed or ulcerating) groin nodes
- Must not require resection of urethra or anal sphincter to achieve negative margins
Must have undergone vulvar biopsy and bilateral inguinal/femoral lymph node dissection within 8 weeks of randomization
No metastatic disease

PATIENT CHARACTERISTICS:

Age:

Any age

Performance status:

GOG 0-2

Life expectancy:

Not specified

Hematopoietic:

WBC at least 3,000/mm^3
Platelet count at least 100,000/mm^3
Granulocyte count at least 1,500/mm^3

Hepatic:

Bilirubin no greater than 1.5 times normal
SGOT no greater than 3 times normal
Alkaline phosphatase no greater than 3 times normal

Renal:

Creatinine no greater than 2.0 mg/dL

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics
No prior radiotherapy

Surgery:

See Disease Characteristics
No more than 8 weeks since prior surgery

Other:

No prior therapy for another malignancy that would preclude study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006096

Hide Study Locations

Locations

United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Community Hospital of Los Gatos
Los Gatos, California, United States, 95032
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Iowa
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, Massachusetts
Tufts University School of Medicine
Boston, Massachusetts, United States, 02111
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
Mallinckrodt Institute of Radiology
Saint Louis, Missouri, United States, 63108
United States, New York
Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
Schneider Children's Hospital at North Shore
Manhasset, New York, United States, 11030
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States, 45267-0502
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
United States, Oklahoma
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States, 73190
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
United States, Tennessee
Brookview Research, Inc.
Nashville, Tennessee, United States, 37203
United States, Texas
M.D. Anderson CCOP Research Base
Houston, Texas, United States, 77030-4009
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
United States, Vermont
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, United States, 05401
United States, Washington
Tacoma General Hospital
Tacoma, Washington, United States, 98405
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon)

GlaxoSmithKline

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068103, GOG-0185
Study First Received:	August 3, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00006096 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I vulvar cancer
stage II vulvar cancer
stage III vulvar cancer
stage IV vulvar cancer
squamous cell carcinoma of the vulva

Additional relevant MeSH terms:

Antineoplastic Agents
Physiological Effects of Drugs
Genital Neoplasms, Female
Urogenital Neoplasms
Pharmacologic Actions
Genital Diseases, Female
Neoplasms

Neoplasms by Site
Cisplatin
Radiation-Sensitizing Agents
Vulvar Neoplasms
Therapeutic Uses
Vulvar Diseases

ClinicalTrials.gov processed this record on November 27, 2009