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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
N/A
N/A
Not Enrolling
Female
Vulvar Cancer

Thank you

Trial Information

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


OBJECTIVES:

- 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


DISEASE CHARACTERISTICS:

- 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
margins

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

- No metastatic disease

PATIENT CHARACTERISTICS:

Age:

- Any age

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

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

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

Hepatic:

- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal

- Alkaline phosphatase no greater than 3 times normal

Renal:

- Creatinine no greater than 2.0 mg/dL

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- No prior radiotherapy

Surgery:

- See Disease Characteristics

- No more than 8 weeks since prior surgery

Other:

- No prior therapy for another malignancy that would preclude study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

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

Investigator Role:

Study Chair

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Federal Government

Study ID:

CDR0000068103

NCT ID:

NCT00006096

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

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Cancer Center of Albany Medical CenterAlbany, New York  12208
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Tacoma General HospitalTacoma, Washington  98405
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Community Hospital of Los GatosLos Gatos, California  95032
Holden Comprehensive Cancer Center at The University of IowaIowa City, Iowa  52242-1009
Tufts University School of MedicineBoston, Massachusetts  02111
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Brookview Research, Inc.Nashville, Tennessee  37203
Mallinckrodt Institute of RadiologySaint Louis, Missouri  63110
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Schneider Children's Hospital at North ShoreManhasset, New York  11030
Fletcher Allen Health Care - Medical Center CampusBurlington, Vermont  05401
M.D. Anderson CCOP Research BaseHouston, Texas  77030-4009