Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva
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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 Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Complete clinical and pathologic tumor response at completion of treatment [ Designated as safety issue: No ]
- Toxicity weekly during treatment then every 3 months after treatment [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 58 |
| Study Start Date: | January 2005 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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 |
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
Show 113 Study Locations| Study Chair: | David H. Moore, MD | Gynecologic Oncology of Indiana |
| Investigator: | Wui-jin Koh, MD | Fred Hutchinson Cancer Research Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00068406 History of Changes |
| Other Study ID Numbers: | CDR0000322259, GOG-0205 |
| Study First Received: | September 10, 2003 |
| Last Updated: | September 2, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
squamous cell carcinoma of the vulva stage III vulvar cancer stage IVB vulvar cancer |
Additional relevant MeSH terms:
|
Carcinoma, Squamous Cell Vulvar Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site 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 May 19, 2013