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4B951, Combination Chemotherapy in Treating Patients With Bladder Cancer

Primary Purpose

Bladder Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
cisplatin
doxorubicin hydrochloride
methotrexate
vinblastine
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring stage I bladder cancer, stage II bladder cancer, transitional cell carcinoma of the bladder

Eligibility Criteria

undefined - 120 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven organ confined transitional cell carcinoma (TCC) of the bladder Must have undergone radical cystectomy and bilateral pelvic lymphadenectomy with pathologic stage from definitive cystectomy specimen of P1, P2a, or P2b and N0, M0 TCC with or without squamous/glandular differentiation (no adenocarcinoma, squamous cell carcinoma, or small cell carcinoma) Margins must be negative for invasive or in situ TCC In situ TCC in the urethra or ureter(s) allowed provided margins are negative Clinical stage T1, T2a, or T2b based on transurethral resection bladder tumor specimen with P0 or PIS and N0, M0 TCC allowed Incidental pT2a (Gleason score no greater than 7), pT2b (Gleason score no greater than 7), or pT2c (Gleason score no greater than 7) adenocarcinoma of the prostate allowed No invasive tumor into ureter(s) or urethra Must have potentially curable disease Must register within 9 weeks after surgery No metastatic disease by physical exam and chest x-ray or CT scan of the chest Eligible for randomization if: p53 gene alteration present Randomization occurs within 10 weeks after surgery Those who are randomized to receive (MVAC) methotrexate, vinblastine, doxorubicin, and cisplatin begin MVAC within 12 weeks after cystectomy No metastatic disease by physical exam and chest x-ray or CT scan of the chest No prohibitive medical risk for chemotherapy PATIENT CHARACTERISTICS: Age Any age Performance status ECOG 0-1 OR Karnofsky 70-100% Life expectancy Not specified Hematopoietic WBC at least 4,000/mm^3 Platelet count at least 150,000/mm^3 Hepatic SGOT or SGPT no greater than 2 times normal Alkaline phosphatase no greater than 2 times normal Bilirubin normal Renal Creatinine no greater than 1.8 mg/dL OR Creatinine clearance at least 50 mL/min Blood urea nitrogen normal Cardiovascular No serious arrhythmias No congestive heart disease with New York Heart Association class III or IV status Randomization group: Ejection fraction must be at least 50% by MUGA scan if there is a clinical concern regarding the patient's cardiac status Other No other malignancy (including synchronous papillary or invasive upper urinary tract malignancy) within the past 5 years except incidental prostate cancer (found at cystectomy), basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix No concurrent advanced medical illness or psychologic disease No prohibitive medical risk for chemotherapy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics No prior systemic chemotherapy for bladder cancer At least 5 years since other prior systemic chemotherapy Prior intravesical therapy allowed Randomization group: Prior intravesical therapy allowed if administered prior to cystectomy Endocrine therapy Not specified Radiotherapy No prior pelvic irradiation Surgery See Disease Characteristics

Sites / Locations

  • Banner Thunderbird Medical Center
  • Banner Good Samaritan Medical Center
  • CCOP - Western Regional, Arizona
  • USC/Norris Comprehensive Cancer Center and Hospital
  • North Colorado Medical Center
  • McKee Medical Center
  • Saint Anthony's Hospital at Saint Anthony's Health Center
  • Cardinal Bernardin Cancer Center at Loyola University Medical Center
  • Good Samaritan Regional Health Center
  • St. Francis Hospital and Health Centers - Beech Grove Campus
  • Cancer Center of Kansas, P.A. - Chanute
  • Cancer Center of Kansas, P.A. - Dodge City
  • Cancer Center of Kansas, P.A. - El Dorado
  • Veterans Affairs Medical Center - Kansas City
  • Cancer Center of Kansas, P.A. - Kingman
  • Southwest Medical Center
  • Cancer Center of Kansas, P.A. - Newton
  • Cancer Center of Kansas, P.A. - Parsons
  • Cancer Center of Kansas, P.A. - Pratt
  • Cancer Center of Kansas, P.A. - Salina
  • Salina Regional Health Center
  • Cancer Center of Kansas, P.A. - Wellington
  • Associates in Womens Health, P.A. - North Review
  • Cancer Center of Kansas, P.A. - Medical Arts Tower
  • Cancer Center of Kansas, P.A. - Wichita
  • CCOP - Wichita
  • Via Christi Cancer Center at Via Christi Regional Medical Center
  • Cancer Center of Kansas, P.A. - Winfield
  • Veterans Affairs Medical Center - Shreveport
  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
  • University of Michigan Comprehensive Cancer Center
  • William Beaumont Hospital - Royal Oak Campus
  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
  • St. Francis Medical Center
  • CCOP - St. Louis-Cape Girardeau
  • David C. Pratt Cancer Center at St. John's Mercy
  • Big Sky Oncology
  • Sletten Regional Cancer Institute
  • Herbert Irving Comprehensive Cancer Center at Columbia University
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Cleveland Clinic Taussig Cancer Center
  • Grandview Hospital
  • Good Samaritan Hospital
  • David L. Rike Cancer Center at Miami Valley Hospital
  • Samaritan North Cancer Care Center
  • Veterans Affairs Medical Center - Dayton
  • CCOP - Dayton
  • Community Oncology Group at Cleveland Clinic Cancer Center
  • Charles F. Kettering Memorial Hospital
  • Middletown Regional Hospital
  • UVMC Cancer Care Center at Upper Valley Medical Center
  • Cleveland Clinic - Wooster
  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  • Brooke Army Medical Center
  • Wilford Hall Medical Center
  • Veterans Affairs Medical Center - San Antonio (Murphy)
  • Cancer Therapy and Research Center
  • University Hospital - San Antonio
  • University of Texas Health Science Center at San Antonio
  • Sentara Cancer Institute at Sentara Norfolk General Hospital
  • St. Joseph Hospital Community Cancer Center
  • Olympic Hematology and Oncology
  • Skagit Valley Hospital Cancer Care Center
  • CCOP - Virginia Mason Research Center
  • Group Health Central Hospital
  • Harborview Medical Center
  • Fred Hutchinson Cancer Research Center
  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  • University Cancer Center at University of Washington Medical Center
  • North Puget Oncology at United General Hospital
  • Cancer Care Northwest - Spokane South
  • Wenatchee Valley Clinic
  • Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
  • Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

No Intervention

No Intervention

Arm Label

Arm I: M-VAC x 3

Arm II: Observation

Arm III: Observation

Arm IV: Observation

Arm Description

Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC

Patients with altered (+) p53, reconsented to randomization, randomized to observation

Patients with unaltered (-) p53

Patients with altered (+) p53, patients did not consent to randomization

Outcomes

Primary Outcome Measures

Probability of Recurring
p53 positive patients randomized to MVAC (arm I) compared to p53 positive patients randomized to observation (arm II). Time from registration to the first observation of disease recurrence, censoring patients who died of unrelated causes. Probabilities of recurring were based on cumulative incidence curves. Recurrence is defined as first radiological appearance of bladder cancer, per local standard of care.

Secondary Outcome Measures

Probability of Overall Survival
p53 positive patients randomized to MVAC (arm I) compared to p53 positive patients randomized to observation (arm II). Survival is calculated from registration to death due to any cause. Probabilities of survival were based on the Kaplan-Meier product-limit method.
Probability of Recurrence
Patients with tumors demonstrating alteration in p53 compared to patients with no p53 alterations. Probabilities of recurring were based on cumulative incidence curves. Recurrence is defined as first radiological appearance of bladder cancer, per local standard of care.
Probability of Overall Survival
Patients with tumors demonstrating alteration in p53 compared to patients with no p53 alterations. Probabilities of survival were based on the Kaplan-Meier product-limit method.

Full Information

First Posted
April 6, 2000
Last Updated
May 10, 2017
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), NCIC Clinical Trials Group, University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT00005047
Brief Title
4B951, Combination Chemotherapy in Treating Patients With Bladder Cancer
Official Title
MVAC (Methotrexate, Vinblastine, Adriamycin, and Cisplatin) in Organ-Confined Bladder Cancer Based on p53 Status
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Accrual was halted on the basis of the Data and Safety Monitoring Board review of a futility analysis.
Study Start Date
August 1997 (Actual)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), NCIC Clinical Trials Group, University of Southern California

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective than observation alone in treating bladder cancer. PURPOSE: This randomized phase III trial is studying combination chemotherapy to see how well it works compared to observation alone in treating patients with bladder cancer.
Detailed Description
OBJECTIVES: Compare the recurrence-free and overall survival in patients with transitional cell carcinoma of the bladder with p53 gene alterations treated with methotrexate, vinblastine, doxorubicin, and cisplatin vs observation alone. Compare the recurrence-free and overall survival in patients with or without p53 gene alterations treated with observation alone. Examine the expression of p53 and other genes, particularly RB, p21, and p16, involved in cell cycle regulation that may be involved in the response to chemotherapy in these patients. Correlate p53 mutational gene status with p53 protein expression by immunohistochemistry, outcome (recurrence-free and overall survival), response to chemotherapy, and expression of key molecules in the p53-mediated apoptotic pathway in patients treated with this regimen vs observation alone. OUTLINE: This is a randomized, multicenter study. Patients are assigned to 1 of 2 treatment groups based on the status of the p53 gene in the bladder tumor. Group A (p53 gene alteration, defined by greater than 10% nuclear reactivity): Patients are stratified according to age (under 65 vs 65 and over), stage (P1 vs P2a vs P2b), grade (1 or 2 vs 3 or 4), and p21 status. Patients are randomized to 1 of 2 treatment arms within 10 weeks after radical cystectomy and bilateral pelvic lymphadenectomy and within 2 weeks after registration. Arm I: Within 2 weeks after randomization, patients receive methotrexate IV on days 1, 15, and 22; vinblastine IV on days 2, 15, and 22; and doxorubicin IV and cisplatin IV on day 2. Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients undergo observation for recurrence but do not receive adjuvant chemotherapy after surgery. Patients who are eligible for randomization but decline to be randomized undergo observation for recurrence. Group B (p53 gene normal, defined by less than 10% nuclear reactivity): Patients undergo observation for recurrence but do not receive adjuvant chemotherapy after surgery. Patients are followed every 6 months for 5 years and then annually thereafter. PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study within 4.75 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
stage I bladder cancer, stage II bladder cancer, transitional cell carcinoma of the bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
521 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I: M-VAC x 3
Arm Type
Experimental
Arm Description
Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC
Arm Title
Arm II: Observation
Arm Type
No Intervention
Arm Description
Patients with altered (+) p53, reconsented to randomization, randomized to observation
Arm Title
Arm III: Observation
Arm Type
No Intervention
Arm Description
Patients with unaltered (-) p53
Arm Title
Arm IV: Observation
Arm Type
No Intervention
Arm Description
Patients with altered (+) p53, patients did not consent to randomization
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Drug
Intervention Name(s)
vinblastine
Primary Outcome Measure Information:
Title
Probability of Recurring
Description
p53 positive patients randomized to MVAC (arm I) compared to p53 positive patients randomized to observation (arm II). Time from registration to the first observation of disease recurrence, censoring patients who died of unrelated causes. Probabilities of recurring were based on cumulative incidence curves. Recurrence is defined as first radiological appearance of bladder cancer, per local standard of care.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Probability of Overall Survival
Description
p53 positive patients randomized to MVAC (arm I) compared to p53 positive patients randomized to observation (arm II). Survival is calculated from registration to death due to any cause. Probabilities of survival were based on the Kaplan-Meier product-limit method.
Time Frame
5 years
Title
Probability of Recurrence
Description
Patients with tumors demonstrating alteration in p53 compared to patients with no p53 alterations. Probabilities of recurring were based on cumulative incidence curves. Recurrence is defined as first radiological appearance of bladder cancer, per local standard of care.
Time Frame
5 years
Title
Probability of Overall Survival
Description
Patients with tumors demonstrating alteration in p53 compared to patients with no p53 alterations. Probabilities of survival were based on the Kaplan-Meier product-limit method.
Time Frame
5 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven organ confined transitional cell carcinoma (TCC) of the bladder Must have undergone radical cystectomy and bilateral pelvic lymphadenectomy with pathologic stage from definitive cystectomy specimen of P1, P2a, or P2b and N0, M0 TCC with or without squamous/glandular differentiation (no adenocarcinoma, squamous cell carcinoma, or small cell carcinoma) Margins must be negative for invasive or in situ TCC In situ TCC in the urethra or ureter(s) allowed provided margins are negative Clinical stage T1, T2a, or T2b based on transurethral resection bladder tumor specimen with P0 or PIS and N0, M0 TCC allowed Incidental pT2a (Gleason score no greater than 7), pT2b (Gleason score no greater than 7), or pT2c (Gleason score no greater than 7) adenocarcinoma of the prostate allowed No invasive tumor into ureter(s) or urethra Must have potentially curable disease Must register within 9 weeks after surgery No metastatic disease by physical exam and chest x-ray or CT scan of the chest Eligible for randomization if: p53 gene alteration present Randomization occurs within 10 weeks after surgery Those who are randomized to receive (MVAC) methotrexate, vinblastine, doxorubicin, and cisplatin begin MVAC within 12 weeks after cystectomy No metastatic disease by physical exam and chest x-ray or CT scan of the chest No prohibitive medical risk for chemotherapy PATIENT CHARACTERISTICS: Age Any age Performance status ECOG 0-1 OR Karnofsky 70-100% Life expectancy Not specified Hematopoietic WBC at least 4,000/mm^3 Platelet count at least 150,000/mm^3 Hepatic SGOT or SGPT no greater than 2 times normal Alkaline phosphatase no greater than 2 times normal Bilirubin normal Renal Creatinine no greater than 1.8 mg/dL OR Creatinine clearance at least 50 mL/min Blood urea nitrogen normal Cardiovascular No serious arrhythmias No congestive heart disease with New York Heart Association class III or IV status Randomization group: Ejection fraction must be at least 50% by MUGA scan if there is a clinical concern regarding the patient's cardiac status Other No other malignancy (including synchronous papillary or invasive upper urinary tract malignancy) within the past 5 years except incidental prostate cancer (found at cystectomy), basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix No concurrent advanced medical illness or psychologic disease No prohibitive medical risk for chemotherapy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics No prior systemic chemotherapy for bladder cancer At least 5 years since other prior systemic chemotherapy Prior intravesical therapy allowed Randomization group: Prior intravesical therapy allowed if administered prior to cystectomy Endocrine therapy Not specified Radiotherapy No prior pelvic irradiation Surgery See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard J. Cote, MD, FRCPath
Organizational Affiliation
University of Southern California
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Laurence H. Klotz, MD
Organizational Affiliation
Toronto Sunnybrook Regional Cancer Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Seth P Lerner, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Banner Thunderbird Medical Center
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Banner Good Samaritan Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
CCOP - Western Regional, Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9181
Country
United States
Facility Name
North Colorado Medical Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Facility Name
McKee Medical Center
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80539
Country
United States
Facility Name
Saint Anthony's Hospital at Saint Anthony's Health Center
City
Alton
State/Province
Illinois
ZIP/Postal Code
62002
Country
United States
Facility Name
Cardinal Bernardin Cancer Center at Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Good Samaritan Regional Health Center
City
Mount Vernon
State/Province
Illinois
ZIP/Postal Code
62864
Country
United States
Facility Name
St. Francis Hospital and Health Centers - Beech Grove Campus
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Cancer Center of Kansas, P.A. - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas, P.A. - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas, P.A. - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Veterans Affairs Medical Center - Kansas City
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
64128
Country
United States
Facility Name
Cancer Center of Kansas, P.A. - Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Southwest Medical Center
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67901
Country
United States
Facility Name
Cancer Center of Kansas, P.A. - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Cancer Center of Kansas, P.A. - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Cancer Center of Kansas, P.A. - Pratt
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas, P.A. - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Salina Regional Health Center
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Cancer Center of Kansas, P.A. - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates in Womens Health, P.A. - North Review
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Cancer Center of Kansas, P.A. - Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas, P.A. - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Via Christi Cancer Center at Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas, P.A. - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
Veterans Affairs Medical Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
William Beaumont Hospital - Royal Oak Campus
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63701
Country
United States
Facility Name
St. Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63701
Country
United States
Facility Name
CCOP - St. Louis-Cape Girardeau
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
David C. Pratt Cancer Center at St. John's Mercy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Big Sky Oncology
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Sletten Regional Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Grandview Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States
Facility Name
Good Samaritan Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
David L. Rike Cancer Center at Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Samaritan North Cancer Care Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Veterans Affairs Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Community Oncology Group at Cleveland Clinic Cancer Center
City
Independence
State/Province
Ohio
ZIP/Postal Code
44131
Country
United States
Facility Name
Charles F. Kettering Memorial Hospital
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Middletown Regional Hospital
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45044
Country
United States
Facility Name
UVMC Cancer Care Center at Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373-1300
Country
United States
Facility Name
Cleveland Clinic - Wooster
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
City
Xenia
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Wilford Hall Medical Center
City
Lackland Air Force Base
State/Province
Texas
ZIP/Postal Code
78236
Country
United States
Facility Name
Veterans Affairs Medical Center - San Antonio (Murphy)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Cancer Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University Hospital - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284-7811
Country
United States
Facility Name
Sentara Cancer Institute at Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
St. Joseph Hospital Community Cancer Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Olympic Hematology and Oncology
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Skagit Valley Hospital Cancer Care Center
City
Mount Vernon
State/Province
Washington
ZIP/Postal Code
98273
Country
United States
Facility Name
CCOP - Virginia Mason Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Group Health Central Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
Facility Name
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98114
Country
United States
Facility Name
University Cancer Center at University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6043
Country
United States
Facility Name
North Puget Oncology at United General Hospital
City
Sedro-Woolley
State/Province
Washington
ZIP/Postal Code
98284
Country
United States
Facility Name
Cancer Care Northwest - Spokane South
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Wenatchee Valley Clinic
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
City
Parkersburg
State/Province
West Virginia
ZIP/Postal Code
26102
Country
United States
Facility Name
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25413313
Citation
von Rundstedt FC, Mata DA, Groshen S, Stein JP, Skinner DG, Stadler WM, Cote RJ, Kryvenko ON, Godoy G, Lerner SP. Significance of lymphovascular invasion in organ-confined, node-negative urothelial cancer of the bladder: data from the prospective p53-MVAC trial. BJU Int. 2015 Jul;116(1):44-9. doi: 10.1111/bju.12997. Epub 2015 Mar 25.
Results Reference
derived

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4B951, Combination Chemotherapy in Treating Patients With Bladder Cancer

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