Stage IV Bladder Cancer Clinical Trial
Official title:
Randomized Phase II Trial of Postoperative Adjuvant IMRT Following Cystectomy for pT3/T4 Urothelial Bladder Cancer
Verified date | March 2018 |
Source | NRG Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 14 |
Est. completion date | February 1, 2017 |
Est. primary completion date | February 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Tom Baker Cancer Centre | Calgary | Alberta |
Canada | Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton | Ontario |
Canada | London Regional Cancer Program | London | Ontario |
Canada | CHUM - Hopital Notre-Dame | Montreal | Quebec |
Canada | Jewish General Hospital | Montreal | Quebec |
Canada | McGill University Department of Oncology | Montreal | Quebec |
Canada | Ottawa Hospital and Cancer Center-General Campus | Ottawa | Ontario |
Canada | Allan Blair Cancer Centre | Regina | Saskatchewan |
Canada | Saskatoon Cancer Centre | Saskatoon | Saskatchewan |
Canada | Odette Cancer Centre- Sunnybrook Health Sciences Centre | Toronto | Ontario |
Israel | Rabin Medical Center | Petach Tikva | |
United States | New Mexico Oncology Hematology Consultants | Albuquerque | New Mexico |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | McFarland Clinic PC-William R Bliss Cancer Center | Ames | Iowa |
United States | Saint Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | Emory Saint Joseph's Hospital | Atlanta | Georgia |
United States | Emory University Hospital Midtown | Atlanta | Georgia |
United States | Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia |
United States | University of Colorado Hospital | Aurora | Colorado |
United States | AIS Cancer Center at San Joaquin Community Hospital | Bakersfield | California |
United States | University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland |
United States | Upper Chesapeake Medical Center | Bel Air | Maryland |
United States | Billings Clinic Cancer Center | Billings | Montana |
United States | Saint Luke's Mountain States Tumor Institute | Boise | Idaho |
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
United States | Henry Ford Cancer Institute?Downriver | Brownstown | Michigan |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Lahey Hospital and Medical Center | Burlington | Massachusetts |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
United States | 21st Century Oncology-Clarkston | Clarkston | Michigan |
United States | Henry Ford Macomb Hospital-Clinton Township | Clinton Township | Michigan |
United States | Memorial Hospital Central | Colorado Springs | Colorado |
United States | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado |
United States | Central Maryland Radiation Oncology in Howard County | Columbia | Maryland |
United States | Bay Area Hospital | Coos Bay | Oregon |
United States | Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri |
United States | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | 21st Century Oncology-Farmington Hills | Farmington Hills | Michigan |
United States | Poudre Valley Hospital | Fort Collins | Colorado |
United States | Parkview Hospital Randallia | Fort Wayne | Indiana |
United States | Radiation Oncology Associates PC | Fort Wayne | Indiana |
United States | Saint Luke's Mountain States Tumor Institute - Fruitland | Fruitland | Idaho |
United States | Northeast Georgia Medical Center-Gainesville | Gainesville | Georgia |
United States | University of Texas Medical Branch | Galveston | Texas |
United States | Tate Cancer Center | Glen Burnie | Maryland |
United States | Goshen Center for Cancer Care | Goshen | Indiana |
United States | Aurora Cancer Care-Grafton | Grafton | Wisconsin |
United States | Aurora BayCare Medical Center | Green Bay | Wisconsin |
United States | Marin General Hospital | Greenbrae | California |
United States | Greenville Health System Cancer Institute-Eastside | Greenville | South Carolina |
United States | Greenville Health System Cancer Institute-Faris | Greenville | South Carolina |
United States | Saint Francis Cancer Center | Greenville | South Carolina |
United States | Greenville Health System Cancer Institute-Greer | Greer | South Carolina |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | University of Kansas Cancer Center | Kansas City | Kansas |
United States | Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | UTMB Cancer Center at Victory Lakes | League City | Texas |
United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Saint Mary Mercy Hospital | Livonia | Michigan |
United States | Logan Regional Hospital | Logan | Utah |
United States | Los Angeles County-USC Medical Center | Los Angeles | California |
United States | USC / Norris Comprehensive Cancer Center | Los Angeles | California |
United States | Jewish Hospital Medical Center Northeast | Louisville | Kentucky |
United States | Norton Hospital Pavilion and Medical Campus | Louisville | Kentucky |
United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Saint Luke's Mountain States Tumor Institute - Meridian | Meridian | Idaho |
United States | Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin |
United States | Aurora Sinai Medical Center | Milwaukee | Wisconsin |
United States | Froedtert and the Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Memorial Regional Cancer Center Day Road | Mishawaka | Indiana |
United States | West Virginia University Healthcare | Morgantown | West Virginia |
United States | Virtua Memorial | Mount Holly | New Jersey |
United States | Intermountain Medical Center | Murray | Utah |
United States | Saint Luke's Mountain States Tumor Institute - Nampa | Nampa | Idaho |
United States | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee |
United States | Christiana Care Health System-Christiana Hospital | Newark | Delaware |
United States | McKay-Dee Hospital Center | Ogden | Utah |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Nebraska Methodist Hospital | Omaha | Nebraska |
United States | Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin |
United States | Stanford Cancer Institute Palo Alto | Palo Alto | California |
United States | OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center | Pekin | Illinois |
United States | OSF Saint Francis Medical Center | Peoria | Illinois |
United States | OSF Saint Francis Radiation Oncology at Peoria Cancer Center | Peoria | Illinois |
United States | NRG Oncology | Philadelphia | Pennsylvania |
United States | University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania |
United States | Saint Joseph Mercy Oakland | Pontiac | Michigan |
United States | Beebe Health Campus | Rehoboth Beach | Delaware |
United States | Renown Regional Medical Center | Reno | Nevada |
United States | University of Rochester | Rochester | New York |
United States | William Beaumont Hospital-Royal Oak | Royal Oak | Michigan |
United States | University of California Davis Comprehensive Cancer Center | Sacramento | California |
United States | Norris Cotton Cancer Center-North | Saint Johnsbury | Vermont |
United States | Missouri Baptist Medical Center | Saint Louis | Missouri |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Regions Hospital | Saint Paul | Minnesota |
United States | Siteman Cancer Center at Saint Peters Hospital | Saint Peters | Missouri |
United States | Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah |
United States | Utah Cancer Specialists-Salt Lake City | Salt Lake City | Utah |
United States | Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia |
United States | Maine Medical Center- Scarborough Campus | Scarborough | Maine |
United States | Seattle Cancer Care Alliance | Seattle | Washington |
United States | University of Washington Medical Center | Seattle | Washington |
United States | Greenville Health System Cancer Institute-Seneca | Seneca | South Carolina |
United States | Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan | Wisconsin |
United States | Robert Wood Johnson University Hospital Somerset | Somerville | New Jersey |
United States | Memorial Hospital of South Bend | South Bend | Indiana |
United States | Greenville Health System Cancer Institute-Spartanburg | Spartanburg | South Carolina |
United States | Spartanburg Medical Center | Spartanburg | South Carolina |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Stony Brook University Medical Center | Stony Brook | New York |
United States | Aurora Medical Center in Summit | Summit | Wisconsin |
United States | Flower Hospital | Sylvania | Ohio |
United States | Moffitt Cancer Center | Tampa | Florida |
United States | 21st Century Oncology-Troy | Troy | Michigan |
United States | William Beaumont Hospital - Troy | Troy | Michigan |
United States | Saint Luke's Mountain States Tumor Institute-Twin Falls | Twin Falls | Idaho |
United States | Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin |
United States | Carle Cancer Center | Urbana | Illinois |
United States | Aurora West Allis Medical Center | West Allis | Wisconsin |
United States | Reading Hospital | West Reading | Pennsylvania |
United States | Dickstein Cancer Treatment Center | White Plains | New York |
United States | Via Christi Regional Medical Center | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
NRG Oncology | National Cancer Institute (NCI) |
United States, Canada, Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pelvic Recurrence-free Survival (PRFS) | PRFS is defined as time free of pelvic recurrence or death, with patients who experience distant metastasis censored at the time of occurrence. Pelvic recurrence is specifically defined as soft tissue and /or lymph node tumor recurrence in the pelvis anywhere between the L5-S1 disc space superiorly and the pelvic floor inferiorly. This was to be determined on the basis of pelvic imaging (CT or MRI scan demonstrating soft tissue or nodal recurrence at least 1cm in linear dimension) or urethroscopy; biopsy was not required. PRFS was to be tested between arms in terms of a difference in cause-specific-hazards using the log-rank test and cumulative incidence of PRFS in the presence of competing risks was to be computed via cumulative incidence. Due to early termination with few patients, only counts of events have been calculated. | From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months | |
Secondary | Disease Free Survival (DFS) | Disease free survival (DFS) is defined as the first occurrence of either: pelvic failure, distant metastasis, or death and was to be estimated by the Kaplan-Meier method and arms compared using the log-rank test. Pelvic recurrence is specifically defined as soft tissue and /or lymph node tumor recurrence in the pelvis anywhere between the L5-S1 disc space superiorly and the pelvic floor inferiorly. This was to be determined on the basis of pelvic imaging (CT or MRI scan demonstrating soft tissue or nodal recurrence at least 1cm in linear dimension) or urethroscopy; biopsy was not required. Distant metastases is defined as any hematogenous metastases and/or lymph node metastases above the L5-S1 interspace, documented by imaging (CT and/or MRI and/or bone scans). Due to early termination with few patients, only counts of events have been calculated. | From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months | |
Secondary | Number of Patients With Bowel Toxicity | Adverse events (AE) evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Bowel toxicity= abdominal distension/pain, colitis, colonic fistula/ hemorrhage/obstruction/perforation/stenosis/ulcer, diarrhea, enterocolitis, fecal incontinence/gastrointestinal/fistula/pain, ileal fistula/hemorrhage/obstruction/perforation/stenosis/ulcer, Ileus, jejunal fistula/hemorrhage/obstruction/perforation/stenosis/ulcer, lower gastrointestinal hemorrhage, rectal fistula/hemorrhage/mucositis/necrosis/obstruction/pain/perforation/stenosis/ulcer, small intestinal mucositis/obstruction/perforation/stenosis/ulcer, vomiting. Highest grade adverse event per subject counted. Grade refers to AE severity and ranges from 1 to 5 with unique clinical descriptions of severity for each AE based on this general guideline: 1 Mild, 2 Moderate, 3 Severe, 4 Life-threatening or disabling, 5 Death related to AE. | From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months |
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