Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva - Full Text View

Purpose

RATIONALE: Drugs used in chemotherapy such as cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery.

PURPOSE: This phase II trial is studying how well giving radiation therapy together with cisplatin followed by surgery works in treating patients with locally advanced cancer of the vulva.

Condition	Intervention	Phase
Vulvar Cancer	Drug: cisplatin Procedure: adjuvant therapy Procedure: conventional surgery Procedure: radiation therapy	Phase II

MedlinePlus related topics:

Cancer Vulvar Cancer

Drug Information available for:

Cisplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label

Official Title:	A Phase II Trial of Radiation Therapy and Weekly Cisplatin Chemotherapy for the Treatment of Locally-Advanced Squamous Cell Carcinoma of the Vulva

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Complete clinical and pathologic tumor response at completion of treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity weekly during treatment then every 3 months after treatment [ Designated as safety issue: Yes ]

Estimated Enrollment:	58
Study Start Date:	January 2005
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the efficacy of radiotherapy and cisplatin, in terms of achieving a complete clinical and pathological response, in patients with locally advanced squamous cell carcinoma of the vulva that is not amenable to standard radical vulvectomy.
Determine the toxicity of this regimen followed by surgery in these patients.

OUTLINE: This is a multicenter study.

Patients undergo radiotherapy daily on days 1-5 and receive concurrent cisplatin IV over 30 minutes on day 1. Treatment repeats weekly for approximately 6.5 weeks (a total of 32 fractions of radiotherapy) in the absence of unacceptable toxicity.

Six to eight weeks after the completion of chemoradiotherapy, patients with a complete clinical response may undergo incisional biopsy of the primary tumor and bilateral inguinal/femoral nodes (if the groin nodes were initially unresectable). Patients with microscopic or gross resectable residual disease may then undergo radical resection of the residual tumor. Patients with unresectable disease after the completion of chemoradiotherapy receive additional radiotherapy with 1-2 courses of concurrent cisplatin.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 25-58 patients will be accrued for this study within 1.8-2.3 years.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of locally advanced squamous cell carcinoma of the vulva
- T3 or T4 (N0-3, M0)
Not amenable to surgical resection by standard radical vulvectomy
Previously untreated disease
No recurrent disease
No vulvar melanoma or sarcoma

PATIENT CHARACTERISTICS:

Age

Any age

Performance status

GOG 0-3

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than 1.5 times normal
Alkaline phosphatase no greater than 3 times normal
SGOT no greater than 3 times normal

Renal

Creatinine no greater than 2.0 mg/dL

Gastrointestinal

No gastrointestinal bleeding
No severe gastrointestinal symptoms

Other

Capable of tolerating a radical course of chemoradiotherapy
No septicemia
No severe infection
No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
No circumstance that would preclude study completion or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior cytotoxic chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No prior pelvic radiotherapy
No concurrent boost brachytherapy

Surgery

Not specified

Other

No prior anticancer therapy that would contraindicate study therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068406

Show 112 Study Locations

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators


Study Chair:	David H. Moore, MD	Gynecologic Oncology of Indiana

Investigator:	Wui-jin Koh, MD	Fred Hutchinson Cancer Research Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000322259, GOG-0205
First Received:	September 10, 2003
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00068406
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

squamous cell carcinoma of the vulva

stage III vulvar cancer

stage IV vulvar cancer

Study placed in the following topic categories:

Squamous cell carcinoma

Genital Neoplasms, Female

Urogenital Neoplasms

Carcinoma

Genital Diseases, Female

Epidermoid carcinoma

Cisplatin

Vulvar Neoplasms

Carcinoma, squamous cell

Neoplasms, Squamous Cell

Carcinoma, Squamous Cell

Vulvar Diseases

Neoplasms, Glandular and Epithelial

Vulvar cancer

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Radiation-Sensitizing Agents

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008

Sponsors and Collaborators:	Gynecologic Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00068406