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

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 2

Conditions: Stage III Vulvar Cancer; Stage IVB Vulvar Cancer; Vulvar Squamous Cell Carcinoma

Treatments: Radiation: 3-Dimensional Conformal Radiation Therapy; Procedure: Conventional Surgery; Drug: Cisplatin

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00068406

U10CA027469 (U.S. NIH Grant/Contract)

NCI-2009-00582 (Registry Identifier)

CDR0000322259

GOG-0205 (Other Identifier)

Details and patient eligibility

About

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. 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.

Full description

OBJECTIVES:

I. 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.

II. 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.

Enrollment: 61 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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

• Performance status - GOG 0-3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Bilirubin no greater than 1.5 times normal

• Alkaline phosphatase no greater than 3 times normal

• SGOT no greater than 3 times normal

• Creatinine no greater than 2.0 mg/dL

• No gastrointestinal bleeding

• No severe gastrointestinal symptoms

• 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

• No prior cytotoxic chemotherapy

• No prior pelvic radiotherapy

• No concurrent boost brachytherapy

• No prior anticancer therapy that would contraindicate study therapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

61 participants in 1 patient group

Treatment (conventional surgery, radiation therapy, cisplatin)

Experimental group

Description:

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.

Treatment:

Drug: Cisplatin

Radiation: 3-Dimensional Conformal Radiation Therapy

Procedure: Conventional Surgery