search
Back to results

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

Primary Purpose

Vulvar Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
cisplatin
radiation therapy
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvar Cancer focused on measuring stage I vulvar cancer, stage II vulvar cancer, stage III vulvar cancer, stage IVB vulvar cancer, squamous cell carcinoma of the vulva

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Community Hospital of Los Gatos
  • Chao Family Comprehensive Cancer Center
  • University of Colorado Cancer Center
  • H. Lee Moffitt Cancer Center and Research Institute
  • Indiana University Cancer Center
  • Holden Comprehensive Cancer Center at The University of Iowa
  • Tufts University School of Medicine
  • Mayo Clinic Cancer Center
  • University of Mississippi Medical Center
  • Ellis Fischel Cancer Center - Columbia
  • Mallinckrodt Institute of Radiology
  • Cancer Center of Albany Medical Center
  • Schneider Children's Hospital at North Shore
  • Lineberger Comprehensive Cancer Center, UNC
  • Duke Comprehensive Cancer Center
  • Comprehensive Cancer Center at Wake Forest University
  • Barrett Cancer Center, The University Hospital
  • Ireland Cancer Center
  • Cleveland Clinic Taussig Cancer Center
  • Arthur G. James Cancer Hospital - Ohio State University
  • University of Oklahoma College of Medicine
  • Abington Memorial Hospital
  • Milton S. Hershey Medical Center
  • Brookview Research, Inc.
  • Simmons Cancer Center - Dallas
  • M.D. Anderson CCOP Research Base
  • Fletcher Allen Health Care - Medical Center Campus
  • Tacoma General Hospital
  • Tom Baker Cancer Center - Calgary
  • Toronto Sunnybrook Regional Cancer Centre

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 3, 2000
Last Updated
June 7, 2013
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00006096
Brief Title
Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva
Official Title
A Randomized Study of Adjuvant Radiation Treatment Versus Radiation and Chemotherapy in Patients With Vulvar Cancer and Involved Nodes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Terminated
Study Start Date
March 2001 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Cancer
Keywords
stage I vulvar cancer, stage II vulvar cancer, stage III vulvar cancer, stage IVB vulvar cancer, squamous cell carcinoma of the vulva

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon)
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Chair
Facility Information:
Facility Name
Community Hospital of Los Gatos
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Holden Comprehensive Cancer Center at The University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Tufts University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Ellis Fischel Cancer Center - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Mallinckrodt Institute of Radiology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Cancer Center of Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Schneider Children's Hospital at North Shore
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Barrett Cancer Center, The University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0502
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
University of Oklahoma College of Medicine
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Brookview Research, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Simmons Cancer Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9154
Country
United States
Facility Name
M.D. Anderson CCOP Research Base
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Fletcher Allen Health Care - Medical Center Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Tacoma General Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Tom Baker Cancer Center - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Toronto Sunnybrook Regional Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs