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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2007 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting

First Received on August 3, 2000. Last Updated on February 6, 2009 History of Changes

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:	Allocation: Randomized Primary Purpose: Treatment
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

Show 30 Study Locations

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

ClinicalTrials.gov Identifier:	NCT00006096 History of Changes
Other Study ID Numbers:	CDR0000068103, GOG-0185
Study First Received:	August 3, 2000
Last Updated:	February 6, 2009
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:

Vulvar Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Vulvar Diseases
Genital Diseases, Female

Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012