Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stageā¦ (NCT00006096) | Clinical Trial Compass
TerminatedPhase 3
Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva
United StatesStarted 2001-03
Plain-language 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.
Who can participate
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 precludā¦