Surgery With or Without Postoperative Intensity Modulated Radiation Therapy in Treating Patients With Urothelial Bladder Cancer



Status:Terminated
Conditions:Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/13/2018
Start Date:February 2015
End Date:February 1, 2017

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Randomized Phase II Trial of Postoperative Adjuvant IMRT Following Cystectomy for pT3/T4 Urothelial Bladder Cancer

This randomized phase II trial studies the side effects and how well postoperative intensity
modulated radiotherapy works after surgery in treating patients with urothelial bladder
cancer. Radiation therapy uses high energy x-rays to kill tumor cells left behind in the
pelvis after surgery. It is not yet known whether surgery followed by radiotherapy is more
effective than surgery alone in treating patients with urothelial bladder cancer.

PRIMARY OBJECTIVE:

I. To evaluate the ability of postcystectomy adjuvant radiotherapy to safely reduce pelvic
tumor recurrence, defined as pelvic recurrence-free survival.

SECONDARY OBJECTIVES:

I. Evaluate increase in disease-free survival. II. Evaluate toxicity of adjuvant pelvic
radiotherapy.

OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients are stratified by
neoadjuvant preoperative or postoperative adjuvant chemotherapy.

After completion of study treatment, patients are followed up at 6 weeks, every 3 months for
1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually for 5 years.

Inclusion Criteria (A patient cannot be considered eligible for this study unless ALL of
the following conditions are met.):

- Initial histological diagnosis of muscle invasive urothelial carcinoma

- Patients must have undergone a radical cystectomy (reconstructed urinary diversion may
be non-continent diversions (eg, ileal conduits) or continent non-orthotopic
catheterizable diversions (eg, Indiana pouch) or continent orthotopic diversions (eg,
Studer pouch or neobladder)for urothelial bladder carcinoma within 105 days prior to
registration. Final cystectomy pathology must be either pure urothelial carcinoma or
dominant urothelial carcinoma with admixture of other histologies excluding small cell
variants.

- Neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy for the
bladder cancer is permitted; however, all patients, even those who will receive
adjuvant chemotherapy, must be registered within 105 days after completing
cystectomy regardless of whether adjuvant chemotherapy has started. Patients who
will be receiving adjuvant (postoperative) chemotherapy will be randomized within
28 days of completing that chemotherapy.

- Patients with the following pTNM stages per the American Joint Committee on Cancer
(AJCC) 7th ed. are eligible:

- pT3apN0; pN1; pN2 provided less than 10 nodes dissected and/or positive surgical
margins

- pT3bpN0; pN1; pN2

- pT4apN0; pN1; pN2

- pT4bpN0; pN1; pN2

- Appropriate stage for study entry based on the following diagnostic workup:

- History/physical examination =< 45 days prior to registration;

- CT or MRI or positron emission tomography(PET)-CT that includes chest, abdomen
and pelvis should be performed for initial radiological staging. This may be
performed pre- or post-surgery ≤ 90 days prior to registration except in patients
getting postoperative adjuvant chemotherapy, who will require CT, MRI or PET-CT
including the chest and abdomen and pelvis no more than 30 days prior to
registration. Imaging performed postoperatively should show no evidence of
residual disease.

- Age >=18

- Zubrod performance status 0-2 =< 45 days prior to registration

- Complete blood count (CBC)/differential obtained ≤ 14 days prior to registration with
adequate bone marrow function defined as follows:

- Absolute neutrophil count (ANC) >= 1,500 cells/mm^3

- Platelets >= 100,000 cells/mm^3

- Hemoglobin >= 8.0 g/dl (NOTE: the use of transfusion or other intervention to
achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)

- The patient must provide study-specific informed consent prior to study entry

- The patient must provide study-specific informed consent prior to study entry.

Exclusion Criteria (Patients with any of the following conditions are NOT eligible for this
study.):

- Definitive clinical or radiologic evidence of metastatic disease; pN3 disease is not
allowed (positive common iliac node).

- Prior invasive solid tumor or hematological malignancy (except non-melanomatous skin
cancer and incidentally discovered prostate cancer at time of cystoprostatectomy)
unless disease free for a minimum of 3 years

- Prior radiotherapy to the pelvis

- Patients with a history of inflammatory bowel disease

- Patients who have required any treatment (medical or surgical) for bowel obstruction
prior to diagnosis of bladder cancer or who have required surgical treatment for bowel
obstruction after the cystectomy

- Severe, active co-morbidity defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the last 6 months;

- Transmural myocardial infarction within the last 6 months;

- Acute bacterial or fungal infection requiring intravenous antibiotics at the time
of registration;

- Severe hepatic disease, defined as a diagnosis of Child-Pugh Class B or C hepatic
disease;

- HIV positive with CD4 count < 200 cells/microliter. Note that patients who are
HIV positive are eligible, provided they are under treatment with highly active
antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within
30 days prior to registration. Note also that HIV testing is not required for
eligibility for this protocol.

- Other major medical illness which requires hospitalization or precludes study
therapy at the time of registration.

- Women who are breastfeeding
We found this trial at
118
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8303 Dodge Street
Omaha, Nebraska 68114
(402) 354–4000
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1201 Camino de Salud Northeast
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666 Elm Street
Buffalo, New York 14263
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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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,...
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2500 N State St
Jackson, Mississippi 39216
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Albuquerque, New Mexico 87109
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1111 Duff Ave
Ames, Iowa 50010
(866) 972-5477
Principal Investigator: James Merchant, MD
Phone: 515-956-2759
McFarland Clinic PC-William R Bliss Cancer Center The William R. Bliss Cancer Center at Mary...
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5301 McAuley Drive
Ann Arbor, Michigan 48197
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550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
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Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Atlanta, Georgia 30342
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
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22 South Greene Street
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Bel Air, Maryland 21014
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Billings, Montana 59101
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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55 Fruit St
Boston, Massachusetts 02114
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Brownstown, Michigan 48183
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Calgary, Alberta
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171 Ashley Avenue
Charleston, South Carolina 29425
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
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Clinton Township, Michigan 48038
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6001 E Woodmen Rd
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10 Barnes West Drive
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2300 N Edward St
Decatur, Illinois 62526
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2799 W Grand Blvd
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1024 S Lemay Ave
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2845 Greenbrier Rd
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Greenbrae, California 94904
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Kansas City, Kansas 66160
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Kenosha, Wisconsin 53142
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325 Maine Street
Lawrence, Kansas 66044
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League City, Texas 77573
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
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Livonia, Michigan 48154
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500 E 1400 N
Logan, Utah 84341
(435) 716-1000
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1983 Marengo St
Los Angeles, California 90033
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1441 Eastlake Ave
Los Angeles, California 90033
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Louisville, Kentucky 40202
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Louisville, Kentucky 40245
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600 Highland Ave
Madison, Wisconsin 53792
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2160 South 1st Avenue
Maywood, Illinois 60153
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9200 W Wisconsin Ave
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Mount Holly, New Jersey 08060
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5121 S Cottonwood St
Murray, Utah 84157
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4755 Ogletown-Stanton Road
Newark, Delaware 19718
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Ogden, Utah 84403
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
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855 N. Westhaven Dr.
Oshkosh, Wisconsin 54904
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875 Blake Wilbur Drive
Palo Alto, California 94304
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Peoria, Illinois 61637
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Philadelphia, Pennsylvania 19103
Principal Investigator: Libni J. Eapen
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Philadelphia, Pennsylvania 19104
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3601 W 13 Mile Rd
Royal Oak, Michigan 48073
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Saint Johnsbury, Vermont 05819
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660 S Euclid Ave
Saint Louis, Missouri 63110
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Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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3015 North Ballas Road
Saint Louis, Missouri 63131
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640 Jackson Street
Saint Paul, Minnesota 55101
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150 Entranceway Drive
Saint Peters, Missouri 63376
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Salt Lake City, Utah 84106
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
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Scarborough, Maine 04074
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1959 NE Pacific St
Seattle, Washington 98195
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1222 N 23rd St
Sheboygan, Wisconsin 53081
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