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A Randomized Study of Adjuvant Radiation Treatment Versus Radiation and Chemotherapy in Patients With Vulvar Cancer and Involved Nodes

Phase 3
Not Enrolling
Vulvar Cancer

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Trial Information

A Randomized Study of Adjuvant Radiation Treatment Versus Radiation and Chemotherapy in Patients With Vulvar Cancer and Involved Nodes


- 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.

Inclusion Criteria


- 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

- Must have undergone vulvar biopsy and bilateral inguinal/femoral lymph node
dissection within 8 weeks of randomization

- No metastatic disease



- Any age

Performance status:

- GOG 0-2

Life expectancy:

- Not specified


- WBC at least 3,000/mm^3

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

- Granulocyte count at least 1,500/mm^3


- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal

- Alkaline phosphatase no greater than 3 times normal


- Creatinine no greater than 2.0 mg/dL


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other prior invasive malignancy within the past 5 years except nonmelanoma skin


Biologic therapy:

- Not specified


- No prior chemotherapy

Endocrine therapy:

- Not specified


- See Disease Characteristics

- No prior radiotherapy


- See Disease Characteristics

- No more than 8 weeks since prior surgery


- No prior therapy for another malignancy that would preclude study

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon)

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Federal Government

Study ID:




Start Date:

March 2001

Completion Date:

Related Keywords:

  • Vulvar Cancer
  • stage I vulvar cancer
  • stage II vulvar cancer
  • stage III vulvar cancer
  • stage IVB vulvar cancer
  • squamous cell carcinoma of the vulva
  • Vulvar Neoplasms



Mayo Clinic Cancer Center Rochester, Minnesota  55905
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Cancer Center of Albany Medical Center Albany, New York  12208
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Abington Memorial Hospital Abington, Pennsylvania  19001
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Tacoma General Hospital Tacoma, Washington  98405
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Community Hospital of Los Gatos Los Gatos, California  95032
Holden Comprehensive Cancer Center at The University of Iowa Iowa City, Iowa  52242-1009
Tufts University School of Medicine Boston, Massachusetts  02111
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Brookview Research, Inc. Nashville, Tennessee  37203
Mallinckrodt Institute of Radiology Saint Louis, Missouri  63110
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Schneider Children's Hospital at North Shore Manhasset, New York  11030
Fletcher Allen Health Care - Medical Center Campus Burlington, Vermont  05401
M.D. Anderson CCOP Research Base Houston, Texas  77030-4009