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

Completed · Phase 2

Conditions studied: Stage III Vulvar Cancer, Stage IVB Vulvar Cancer, Vulvar Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT00068406

Run by

Gynecologic Oncology Group

People needed

61

Starts

2005-01-01

Expected to finish

2012-01-20

Last updated by the study team

2017-11-20

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Banner Thunderbird Medical Center — Glendale, Arizona, United States
• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States
• Western Regional CCOP — Phoenix, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• Colorado Gynecologic Oncology Group — Aurora, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• McKee Medical Center — Loveland, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Lakeland Regional Cancer Center — Lakeland, Florida, United States
• UF Cancer Center at Orlando Health — Orlando, Florida, United States
• Central Georgia Gynecologic Oncology — Macon, Georgia, United States
• Memorial University Medical Center — Savannah, Georgia, United States
• Rush - Copley Medical Center — Aurora, Illinois, United States
• University of Illinois — Chicago, Illinois, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Joliet Oncology-Hematology Associates Limited — Joliet, Illinois, United States
• Memorial Medical Center — Springfield, Illinois, United States
• Carle Clinic-Urbana Main — Urbana, Illinois, United States
• Elkhart General Hospital — Elkhart, Indiana, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.