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
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.
Study Phase
Phase 3
Study Type
Interventional
Condition
Vulvar Cancer
Intervention
cisplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
March 2001
Primary Completion Date
January 2003
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
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon), ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00006096
Organization ID
CDR0000068103
Secondary IDs
GOG-0185
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon), Study Chair, GlaxoSmithKline
Verification Date
June 2007