Clinical trial NCT00006096: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: 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
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-09-03
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Gatos
country: United States
facility: Community Hospital of Los Gatos
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center
state: California
city: Denver
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center at The University of Iowa
state: Iowa
city: Boston
country: United States
facility: Tufts University School of Medicine
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center - Columbia
state: Missouri
city: Saint Louis
country: United States
facility: Mallinckrodt Institute of Radiology
state: Missouri
city: Albany
country: United States
facility: Cancer Center of Albany Medical Center
state: New York
city: Manhasset
country: United States
facility: Schneider Children's Hospital at North Shore
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center, UNC
state: North Carolina
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
city: Cincinnati
country: United States
facility: Barrett Cancer Center, The University Hospital
state: Ohio
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital - Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma College of Medicine
state: Oklahoma
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Brookview Research, Inc.
state: Tennessee
city: Dallas
country: United States
facility: Simmons Cancer Center - Dallas
state: Texas
city: Houston
country: United States
facility: M.D. Anderson CCOP Research Base
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care - Medical Center Campus
state: Vermont
city: Tacoma
country: United States
facility: Tacoma General Hospital
state: Washington
city: Calgary
country: Canada
facility: Tom Baker Cancer Center - Calgary
state: Alberta
city: Toronto
country: Canada
facility: Toronto Sunnybrook Regional Cancer Centre
state: Ontario
Study officials:
affiliation: GlaxoSmithKline
name: Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon)
role: STUDY_CHAIR
References: