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| ID | Type | Description | Link |
|---|---|---|---|
| SWOG-S1011 | Other Grant/Funding Number | U10CA180888 | |
| NCI-2011-02604 | Registry Identifier | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in patients with invasive bladder cancer. It is not yet known whether extended pelvic lymphadenectomy is more effective than standard pelvic lymphadenectomy during surgery.
PURPOSE: This randomized phase II trial is studying standard pelvic lymphadenectomy to see how well it works compared to extended pelvic lymphadenectomy in treating patients undergoing surgery for invasive bladder cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to prior neoadjuvant therapy (yes vs no), clinical stage (T2 vs T3 vs T4a), and Zubrod performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.
Blood and tumor specimens may be collected periodically for translational studies.
After completion of study therapy, patients are followed up periodically for 6 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Active Comparator | therapeutic conventional surgery therapeutic standard lymphadenectomy |
|
| Arm II | Experimental | therapeutic conventional surgery therapeutic extended lymphadenectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic conventional surgery | Procedure | Patients undergo radical cystectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 5-year Disease-free Survival (DFS) | Comparing 5-year disease-free survival (DFS) in participants undergoing radical cystectomy for muscle-invasive urothelial carcinoma of the bladder (UCB) treated with radical cystectomy and extended pelvic lymph node dissection (PLND) compared to radical cystectomy and standard pelvic lymphadenectomy. Disease-free survival is defined as the time from the date of randomization to date of first documentation of relapse/recurrence or death due to any cause. Participants last known to be alive without report of relapse/recurrence are censored at date of last contact. Criteria for recurrence included measurable disease on cross-sectional imaging or plain radiography targeting lung, liver, and bone. If local pelvic recurrence was identified on digital rectal examination, biopsy was required for confirmation. Second primary tumors of the upper urinary tract or retained urethra were not considered to be recurrence. | Duration of treatment and follow-up until death or 6 years after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year Overall Survival (OS) | Comparing 5-year overall survival (OS) in participants randomized to extended PLND versus those randomized to standard pelvic lymphadenectomy. Overall survival is defined as the time from date of randomization to date of death from any cause. Participants known to be alive are censored at date of last contact. | Duration of treatment and follow-up until death or 6 years after randomization |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed urothelial carcinoma of the bladder
Stage T2, T3, or T4a disease
Disease that requires primary radical cystectomy and lymph node dissection for definitive treatment
Predominant urothelial carcinoma with any of the following elements allowed:
No visceral or nodal metastatic disease proximal to the common iliac bifurcation by 2-view chest x-ray and abdominal-pelvic imaging by computerized tomography or MRI of the abdomen and pelvis
No intra-operative pelvic lymph node involvement (confirmed by frozen section) at or above the bifurcation of the common iliac vessels in any of the extended template
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Seth P. Lerner, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles County-USC Medical Center | Los Angeles | California | 90033 | United States | ||
| USC / Norris Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39589370 | Derived | Lerner SP, Tangen C, Svatek RS, Daneshmand S, Pohar KS, Skinner E, Schuckman A, Sagalowsky AI, Smith ND, Kamat AM, Kassouf W, Plets M, Bangs R, Koppie TM, Alva A, La Rosa FG, Pal SK, Kibel AS, Canter DJ, Thompson IM Jr; SWOG S1011 Trial Investigators. Standard or Extended Lymphadenectomy for Muscle-Invasive Bladder Cancer. N Engl J Med. 2024 Oct 3;391(13):1206-1216. doi: 10.1056/NEJMoa2401497. | |
| 27345655 |
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658 participants were enrolled to Step 1 before surgery. 40 of participants did not undergo randomization primarily due to results of their intraoperative assessment. Thus, 618 participants were randomized to Step 2; 315 on the standard LND arm and 303 on the extended LND arm. 26 randomized participants were deemed ineligible. Which leaves a total of 592 randomized and eligible participants, 300 and 292 on the standard and extended LND, respectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard LND | Active Comparator: Arm I Procedure/Surgery: therapeutic standard lymphadenectomy |
| FG001 | Extended LND | Experimental: Arm II Procedure/Surgery: therapeutic extended lymphadenectomy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 4, 2018 |
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| therapeutic standard lymphadenectomy | Procedure | Patients undergo standard pelvic lymphadenectomy. |
|
| therapeutic extended lymphadenectomy | Procedure | Patients undergo extended pelvic lymphadenectomy |
|
| Median Operative Time | Evaluating duration of surgery in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy. | Duration of surgery |
| Median Days in Hospital | Evaluating duration of post-operative hospital stay in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy. | From date of operation to 90 days post-operation |
| Use of Nerve Preservation | Evaluating the frequency of nerve sparing surgery in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy. | Duration of surgery |
| Lymph Node Counts | Evaluating the number of positive lymph nodes removed during surgery as well as the total number of lymph nodes removed in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy. | Duration of surgery |
| Receipt of Adjuvant Chemotherapy | Evaluating the receipt of adjuvant chemotherapy in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy. Participants that reported plans to start adjuvant chemotherapy are included in these counts. | From date of operation to 90 days post-operation |
| Frequency of Post-Operative Local Recurrence | Evaluating the frequency of post-operative local and retroperitoneal soft-tissue recurrence in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy. | From date of operation to 90 days post-operation |
| Post-Operative Morbidity | Evaluating perioperative morbidity (death within 30 days of surgery) and post-operative morbidity (death within 90 days of surgery) in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy. | From date of operation to 90 days post-operation |
| Los Angeles |
| California |
| 90033 |
| United States |
| Stanford Cancer Institute | Palo Alto | California | 94304 | United States |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| UCSF Medical Center-Mount Zion | San Francisco | California | 94115 | United States |
| UCSF Medical Center-Mission Bay | San Francisco | California | 94158 | United States |
| University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Louisiana State University Health Sciences Center Shreveport | Shreveport | Louisiana | 71103 | United States |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Portland Veterans Administration Medical Center | Portland | Oregon | 97239 | United States |
| Parkland Memorial Hospital | Dallas | Texas | 75235 | United States |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | United States |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | 77030 | United States |
| Baylor Saint Luke's Medical Center | Houston | Texas | 77030 | United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Audie L Murphy Veterans Affairs Hospital | San Antonio | Texas | 78209 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| BCCA-Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| QEII Health Sciences Centre/Capital District Health Authority | Halifax | Nova Scotia | B3H 1V8 | Canada |
| London Regional Cancer Program | London | Ontario | N6A 4L6 | Canada |
| University Health Network-Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| McGill University Department of Oncology | Montreal | Quebec | H2W 1S6 | Canada |
| The Research Institute of the McGill University Health Centre (MUHC) | Montreal | Quebec | H3H 2R9 | Canada |
| Derived |
| Kamat AM, Hahn NM, Efstathiou JA, Lerner SP, Malmstrom PU, Choi W, Guo CC, Lotan Y, Kassouf W. Bladder cancer. Lancet. 2016 Dec 3;388(10061):2796-2810. doi: 10.1016/S0140-6736(16)30512-8. Epub 2016 Jun 23. |
| 25150172 | Derived | Froehner M, Novotny V, Heberling U, Rutsch L, Litz RJ, Hubler M, Koch R, Baretton GB, Wirth MP. Relationship of the number of removed lymph nodes to bladder cancer and competing mortality after radical cystectomy. Eur Urol. 2014 Dec;66(6):987-90. doi: 10.1016/j.eururo.2014.07.046. Epub 2014 Aug 19. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard LND | Active Comparator: Arm I Procedure/Surgery: therapeutic standard lymphadenectomy |
| BG001 | Extended LND | Experimental: Arm II Procedure/Surgery: therapeutic extended lymphadenectomy |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Race | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Hispanic ethnicity | Count of Participants | Participants |
| |||||||||||||||
| Body Mass Index (BMI) | The body mass index (BMI) is the weight in kilograms divided by the square of the height in meters. | Median | Full Range | kg/m^2 |
| ||||||||||||||
| Zubrod Performance Status of 0 or 1 | Zubrod's performance status scores are assessed on a 5-point scale, with higher numbers indicating greater disability. A score of 0 indicates asymptomatic, a score of 1 indicates symptomatic but completely ambulatory, and a score of 2 indicates ambulatory but unable to carry out work activities. | Count of Participants | Participants |
| |||||||||||||||
| Clinical T Stage | Clinical stage of the primary tumor is assessed using AJCC seventh edition, 2010 and is based on TURBT(s) that determined the need for cystectomy, bimanual exam, and cross-sectional imaging. Higher numbers indicate more extensive invasion by the primary tumor. A clinical stage of T2 indicates the tumor invades muscularis propria, T3 the tumor invades perivesical tissue, and T4a indicates the tumor invades the prostatic stoma, uterus, or vagina. | Count of Participants | Participants |
| |||||||||||||||
| Hydronephrosis | Participants who experienced hydronephrosis are reported. Hydronephrosis, also known as obstructive uropathy, is a condition of excess urine accumulation in kidney(s) that causes swelling of the kidneys. | Count of Participants | Participants |
| |||||||||||||||
| Mixed Histologic Subtypes | The number of participants with mixed histology (versus pure urothelial histology) are reported. | Count of Participants | Participants |
| |||||||||||||||
| Neoadjuvant Chemotherapy | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 5-year Disease-free Survival (DFS) | Comparing 5-year disease-free survival (DFS) in participants undergoing radical cystectomy for muscle-invasive urothelial carcinoma of the bladder (UCB) treated with radical cystectomy and extended pelvic lymph node dissection (PLND) compared to radical cystectomy and standard pelvic lymphadenectomy. Disease-free survival is defined as the time from the date of randomization to date of first documentation of relapse/recurrence or death due to any cause. Participants last known to be alive without report of relapse/recurrence are censored at date of last contact. Criteria for recurrence included measurable disease on cross-sectional imaging or plain radiography targeting lung, liver, and bone. If local pelvic recurrence was identified on digital rectal examination, biopsy was required for confirmation. Second primary tumors of the upper urinary tract or retained urethra were not considered to be recurrence. | Posted | Number | percentage of participants | Duration of treatment and follow-up until death or 6 years after randomization |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 5-year Overall Survival (OS) | Comparing 5-year overall survival (OS) in participants randomized to extended PLND versus those randomized to standard pelvic lymphadenectomy. Overall survival is defined as the time from date of randomization to date of death from any cause. Participants known to be alive are censored at date of last contact. | Posted | Number | percentage of participants | Duration of treatment and follow-up until death or 6 years after randomization |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Operative Time | Evaluating duration of surgery in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy. | Posted | Median | Inter-Quartile Range | hours | Duration of surgery |
|
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| Secondary | Median Days in Hospital | Evaluating duration of post-operative hospital stay in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy. | Posted | Median | Inter-Quartile Range | days | From date of operation to 90 days post-operation |
|
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| Secondary | Use of Nerve Preservation | Evaluating the frequency of nerve sparing surgery in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy. | The overall number of nerve-sparing surgeries performed per arm is reported as well as the numbers for males and females on each arm. The standard LND arm has 234 male participants and 66 females, while the extended LND arm has 236 males and 56 females. | Posted | Count of Participants | Participants | Duration of surgery |
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| Secondary | Lymph Node Counts | Evaluating the number of positive lymph nodes removed during surgery as well as the total number of lymph nodes removed in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy. | Posted | Median | Full Range | number of lymph nodes | Duration of surgery |
|
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| Secondary | Receipt of Adjuvant Chemotherapy | Evaluating the receipt of adjuvant chemotherapy in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy. Participants that reported plans to start adjuvant chemotherapy are included in these counts. | Posted | Number | percentage of participants | From date of operation to 90 days post-operation |
|
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| Secondary | Frequency of Post-Operative Local Recurrence | Evaluating the frequency of post-operative local and retroperitoneal soft-tissue recurrence in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy. | Posted | Number | percentage of participants | From date of operation to 90 days post-operation |
|
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| Secondary | Post-Operative Morbidity | Evaluating perioperative morbidity (death within 30 days of surgery) and post-operative morbidity (death within 90 days of surgery) in participants randomized to extended lymphadenectomy versus those randomized to standard lymphadenectomy. | Posted | Count of Participants | Participants | From date of operation to 90 days post-operation |
|
|
Duration of treatment and follow-up until death or 6 years after randomization
592 eligible participants who received protocol treatment were evaluable for AEs: 300 on the Standard Pelvic Lymph Node Dissection arm and 292 on the Extended Pelvic Lymph Node Dissection arm. Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard LND | Active Comparator: Arm I Procedure/Surgery: therapeutic standard lymphadenectomy | 117 | 300 | 3 | 300 | 226 | 300 |
| EG001 | Extended LND | Experimental: Arm II Procedure/Surgery: therapeutic extended lymphadenectomy | 124 | 292 | 12 | 292 | 219 | 292 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Enterovesical fistula | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal fistula | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Death NOS | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Sudden death NOS | General disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cardiac troponin I increased | Investigations | Systematic Assessment |
| ||
| Creatinine increased | Investigations | Systematic Assessment |
| ||
| Ejection fraction decreased | Investigations | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Stroke | Nervous system disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Edema limbs | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Wound infection | Infections and infestations | Systematic Assessment |
| ||
| Wound complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Creatinine increased | Investigations | Systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Weight loss | Investigations | Systematic Assessment |
| ||
| Acidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Surgical and medical procedures-Other | Surgical and medical procedures | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SWOG Statistician | SWOG Statistics and Data Management Center | 2066674623 | ctangen@fredhutch.org |
| Oct 10, 2024 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| Male |
|
| Black |
|
| Asian |
|
| Other, Multiracial, Unknown |
|
| 2 |
|
| T3 or T4a |
|
| Cisplatin-based |
|
| Carboplatin-based |
|
| Other neoadjuvant chemotherapy |
|
| None |
|
| Superiority |
|
|
|
|
|
|
|
|
|
| Unilateral |
|
| Bilateral |
|
| Unilateral |
|
| Bilateral |
|