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



Status:Completed
Conditions:Cervical Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:11/22/2017
Start Date:January 2005
End Date:January 20, 2012

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A Phase II Trial of Radiation Therapy and Weekly Cisplatin Chemotherapy for the Treatment of Locally-Advanced Squamous Cell Carcinoma of the Vulva

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.

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.

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
We found this trial at
103
sites
3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
826
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Flint, MI
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
607
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Galveston, TX
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3525
Lakeland, Florida 33805
1134
mi
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Lakeland, FL
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
370
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Little Rock, AR
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
1410
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
1227
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Abington, PA
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Allentown, Pennsylvania 18103
1207
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Allentown, PA
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
811
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Ann Arbor, Michigan 48106
806
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Ann Arbor, MI
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Aurora, Colorado 80010
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Aurora, CO
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2000 Ogden Ave
Aurora, Illinois 60504
(630) 978-6200
Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
575
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1154
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Baltimore, MD
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Baton Rouge, Louisiana 70815
634
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Baton Rouge, LA
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684
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Birmingham, AL
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Chapel Hill, North Carolina 27599
1038
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Chapel Hill, NC
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Charlotte, North Carolina 28204
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Charlotte, NC
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1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
Univ of Illinois A major research university in the heart of one of the world's...
608
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
726
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18101 Lorain Avenue
Cleveland, Ohio 44111
216.476.7000
Cleveland Clinic Cancer Center at Fairview Hospital Fairview Hospital is a 488-bed hospital located at...
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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810
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Columbus, Ohio 43222
809
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Columbus, OH
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
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Dearborn, Michigan 48124
831
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
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22101 Moross Rd
Detroit, Michigan 48236
(313) 343-4000
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600 East Blvd
Elkhart, Indiana 46515
(574) 294-2621
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420 S Saginaw St
Flint, Michigan 48502
810-232-3522
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Glendale, Arizona 85306
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Grand Rapids, Michigan 49546
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Grand Rapids, Michigan 49506
734
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100 Michigan St NE
Grand Rapids, Michigan 49503
(616) 391-1774
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1801 16th St
Greeley, Colorado 80631
(970) 352-4121
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411
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835 S Van Buren St
Green Bay, Wisconsin 54301
(920) 433-0111
691
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835 S. Van Buren St.
Green Bay, Wisconsin 54301
(920) 884-3135
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1726 Shawano Ave.
Green Bay, Wisconsin 54303
(920) 884-3135
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691
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1726 Shawano Ave
Green Bay, Wisconsin 54303
(920) 498-4200
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
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Independence, Missouri 64057
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Indianapolis, Indiana 46237
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535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
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429
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205 NE Ave
Jackson, Michigan 49201
(517) 788-4800
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
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579
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Joplin, Missouri 64804
189
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8929 Parallel Pkwy
Kansas City, Kansas 66112
(913) 596-4000
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Kansas City, Missouri 64114
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202
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Knoxville, Tennessee 37920
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3500 S. Lafountain Street
Kokomo, Indiana 46902
765-453-0702
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La Crosse, Wisconsin
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La Porte, Indiana 46350
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1215 E Michigan Ave
Lansing, Michigan 48912
(517) 364-1000
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325 Maine Street
Lawrence, Kansas 66044
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Livonia, Michigan 48154
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
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2000 N Boise Ave
Loveland, Colorado 80538
(970) 669-4640
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868
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
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9485 Mentor Ave
Mentor, Ohio 44060
(440) 205-5755
Lake University Ireland Cancer Center Lake Health is a private, not-for-profit leader in community health...
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Michigan City, Indiana 46360
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Minneapolis, Minnesota 55455
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100 Grand St
New Britain, Connecticut 06050
(860) 224-5011
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New Brunswick, New Jersey 08903
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
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Orlando, Florida 32806
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187
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Phoenix, Arizona 85006
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Phoenix, Arizona 85006
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Pontiac, Michigan 48341
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2601 Electric Ave
Port Huron, Michigan 48060
(810) 985-1500
Saint Joseph Mercy Port Huron St. Joseph Mercy Hospital, Port Huron, MI is a 164-bed...
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Providence, Rhode Island 02905
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Rapid City, South Dakota 57701
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Roanoke, Virginia 24016
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Rochester, Minnesota 55905
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800 S Washington Ave
Saginaw, Michigan 48601
(989) 907-8000
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Saint Joseph, Michigan 49085
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660 S Euclid Ave
Saint Louis, Missouri 63110
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Savannah, Georgia 31404
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1959 NE Pacific St
Seattle, Washington 98195
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615 N Michigan St
South Bend, Indiana 46601
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211 North Eddy St.
South Bend, Indiana 46617
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615 N Michigan Street
South Bend, Indiana 46601
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701 N 1st St
Springfield, Illinois 62781
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759 Chestnut Street
Springfield, Massachusetts 01199
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101 Nicolls Rd
Stony Brook, New York 11794
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Tacoma, Washington 98405
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Tulsa, Oklahoma 74104
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Urbana, Illinois 61801
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11800 E 12 Mile Rd
Warren, Michigan 48093
(586) 573-5000
Saint John Macomb-Oakland Hospital St. John Macomb-Oakland Hospital, Macomb Center, is a 376-bed facility offering...
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