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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01964 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000732793 | |||
| GOG-0279 | Other Identifier | NRG Oncology | |
| GOG-0279 | Other Identifier | CTEP | |
| U10CA180868 | U.S. NIH Grant/Contract | View source | |
| U10CA027469 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well radiation therapy works when given with gemcitabine hydrochloride and cisplatin work in treating patients with squamous cell cancer of the vulva that has spread from where it started to nearby tissue or lymph nodes. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving radiation therapy together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To determine the efficacy of cisplatin, gemcitabine (gemcitabine hydrochloride), and intensity-modulated radiation therapy (IMRT) in achieving a complete pathologic response when used for the primary treatment of locally-advanced squamous cell carcinoma of the vulva.
SECONDARY OBJECTIVES:
I. To determine the efficacy of cisplatin, gemcitabine, and IMRT in achieving a complete clinical response when used for the primary treatment of locally-advanced squamous cell carcinoma of the vulva.
II. To determine the vulvar progression-free survival and groin progression-free survival in women treated with cisplatin, gemcitabine and IMRT for locally advanced vulvar carcinoma.
III. To determine the toxicity and surgical morbidity of the combined modality approach of cisplatin, gemcitabine and IMRT followed by reduced-scope surgery for the treatment of locally-advanced vulvar carcinoma.
OUTLINE:
Patients undergo IMRT 5 days a week for 6 weeks. Patients also receive gemcitabine hydrochloride intravenously (IV) over 30 minutes and cisplatin IV over 60 minutes weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after completion of chemoradiation patients undergo local core biopsy to confirm response or surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (IMRT, gemcitabine, cisplatin, surgery) | Experimental | Patients undergo IMRT 5 days a week for 6 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 60 minutes weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after completion of chemoradiation patients undergo local core biopsy to confirm response or surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Pathologic Response | Percentage of participants with complete pathologic response. Complete pathologic response is defined as negative local core biopsy or FNA specimens following primary chemo-radiation therapy. | 6 -8 weeks after completion of chemo-radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Clinical Response | Percentage of participants with complete clinical response. Complete clinical response is defined as no clinical/radiographic evidence of primary disease (vulva or groin) following primary chemo-radiation therapy. | 6-8 weeks after completion of chemo-radiation |
| Adverse Events (Grade 3 or Higher) During Treatment Period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil S Horowitz | NRG Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | United States | ||
| Anchorage Associates in Radiation Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38574312 | Derived | Horowitz NS, Deng W, Peterson I, Mannel RS, Thompson S, Lokich E, Myers T, Hanjani P, O'Malley DM, Chung KY, Miller DS, Ueland FR, Dizon DS, Miller A, Mayadev JS, Leath CA 3rd, Monk BJ. Phase II Trial of Cisplatin, Gemcitabine, and Intensity-Modulated Radiation Therapy for Locally Advanced Vulvar Squamous Cell Carcinoma: NRG Oncology/GOG Study 279. J Clin Oncol. 2024 Jun 1;42(16):1914-1921. doi: 10.1200/JCO.23.02235. Epub 2024 Apr 4. |
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GOG-0279 was activated on 07/02/2012 and closed to accrual on February 20, 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | GEM+CIS+IMRT | Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2016 |
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| Gemcitabine Hydrochloride | Drug | Given IV |
|
|
| Intensity-Modulated Radiation Therapy | Radiation | Undergo IMRT |
|
|
| Therapeutic Conventional Surgery | Procedure | Undergo local core biopsy or surgical excision |
|
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0. |
| During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months. |
| Progression-free Survival (PFS) | Estimate for probability of progression free survival by Kaplan-Meier method, where progression-free survival is defined as the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. PFS is censored in patients who are alive and have not progressed. Progression is assessed by RECIST 1.1 | From study entry to disease progression, death or date of last contact, whichever occurs first. The median for observed PFS was 26.2 month with a range from 1.5 months to 82.4 months |
| Anchorage |
| Alaska |
| 98508 |
| United States |
| Anchorage Radiation Therapy Center | Anchorage | Alaska | 99504 | United States |
| Alaska Breast Care and Surgery LLC | Anchorage | Alaska | 99508 | United States |
| Alaska Oncology and Hematology LLC | Anchorage | Alaska | 99508 | United States |
| Alaska Women's Cancer Care | Anchorage | Alaska | 99508 | United States |
| Anchorage Oncology Centre | Anchorage | Alaska | 99508 | United States |
| Katmai Oncology Group | Anchorage | Alaska | 99508 | United States |
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | United States |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | 91505 | United States |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| The Hospital of Central Connecticut | New Britain | Connecticut | 06050 | United States |
| Beebe Medical Center | Lewes | Delaware | 19958 | United States |
| Christiana Gynecologic Oncology LLC | Newark | Delaware | 19713 | United States |
| Delaware Clinical and Laboratory Physicians PA | Newark | Delaware | 19713 | United States |
| Helen F Graham Cancer Center | Newark | Delaware | 19713 | United States |
| Medical Oncology Hematology Consultants PA | Newark | Delaware | 19713 | United States |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | United States |
| Beebe Health Campus | Rehoboth Beach | Delaware | 19971 | United States |
| TidalHealth Nanticoke / Allen Cancer Center | Seaford | Delaware | 19973 | United States |
| Christiana Care Health System-Wilmington Hospital | Wilmington | Delaware | 19801 | United States |
| Augusta University Medical Center | Augusta | Georgia | 30912 | United States |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia | 31405 | United States |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | United States |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | United States |
| The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii | 96817 | United States |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| The Cancer Center of Hawaii-Pali Momi | ‘Aiea | Hawaii | 96701 | United States |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | United States |
| Saint Luke's Cancer Institute - Fruitland | Fruitland | Idaho | 83619 | United States |
| Saint Luke's Cancer Institute - Meridian | Meridian | Idaho | 83642 | United States |
| Saint Luke's Cancer Institute - Nampa | Nampa | Idaho | 83686 | United States |
| Saint Luke's Cancer Institute - Twin Falls | Twin Falls | Idaho | 83301 | United States |
| Rush - Copley Medical Center | Aurora | Illinois | 60504 | United States |
| Saint Joseph Medical Center | Bloomington | Illinois | 61701 | United States |
| Illinois CancerCare-Bloomington | Bloomington | Illinois | 61704 | United States |
| Illinois CancerCare-Canton | Canton | Illinois | 61520 | United States |
| Memorial Hospital of Carbondale | Carbondale | Illinois | 62902 | United States |
| SIH Cancer Institute | Carterville | Illinois | 62918 | United States |
| Illinois CancerCare-Carthage | Carthage | Illinois | 62321 | United States |
| Centralia Oncology Clinic | Centralia | Illinois | 62801 | United States |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | United States |
| Carle on Vermilion | Danville | Illinois | 61832 | United States |
| Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | 62526 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Carle Physician Group-Effingham | Effingham | Illinois | 62401 | United States |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | United States |
| Illinois CancerCare-Eureka | Eureka | Illinois | 61530 | United States |
| Illinois CancerCare-Galesburg | Galesburg | Illinois | 61401 | United States |
| Western Illinois Cancer Treatment Center | Galesburg | Illinois | 61401 | United States |
| Northwestern Medicine Cancer Center Delnor | Geneva | Illinois | 60134 | United States |
| Sudarshan K Sharma MD Limited-Gynecologic Oncology | Hinsdale | Illinois | 60521 | United States |
| Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | 61443 | United States |
| Illinois CancerCare-Macomb | Macomb | Illinois | 61455 | United States |
| Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | 61938 | United States |
| Good Samaritan Regional Health Center | Mount Vernon | Illinois | 62864 | United States |
| UC Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois | 60451 | United States |
| Cancer Care Center of O'Fallon | O'Fallon | Illinois | 62269 | United States |
| Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | 61350 | United States |
| Radiation Oncology of Northern Illinois | Ottawa | Illinois | 61350 | United States |
| Illinois CancerCare-Pekin | Pekin | Illinois | 61554 | United States |
| OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center | Pekin | Illinois | 61554 | United States |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | United States |
| OSF Saint Francis Radiation Oncology at Peoria Cancer Center | Peoria | Illinois | 61615 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Illinois CancerCare-Peru | Peru | Illinois | 61354 | United States |
| Valley Radiation Oncology | Peru | Illinois | 61354 | United States |
| Illinois CancerCare-Princeton | Princeton | Illinois | 61356 | United States |
| Central Illinois Hematology Oncology Center | Springfield | Illinois | 62702 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Springfield Clinic | Springfield | Illinois | 62702 | United States |
| Memorial Medical Center | Springfield | Illinois | 62781 | United States |
| Southwest Illinois Health Services LLP | Swansea | Illinois | 62226 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| The Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| Rush-Copley Healthcare Center | Yorkville | Illinois | 60560 | United States |
| Parkview Hospital Randallia | Fort Wayne | Indiana | 46805 | United States |
| Parkview Regional Medical Center | Fort Wayne | Indiana | 46845 | United States |
| Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Saint Elizabeth Medical Center South | Edgewood | Kentucky | 41017 | United States |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | United States |
| Woman's Hospital | Baton Rouge | Louisiana | 70817 | United States |
| Ochsner Baptist Medical Center | New Orleans | Louisiana | 70115 | United States |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | United States |
| Christiana Care - Union Hospital | Elkton | Maryland | 21921 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Weisberg Cancer Treatment Center | Farmington Hills | Michigan | 48334 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49048 | United States |
| Sanford Joe Lueken Cancer Center | Bemidji | Minnesota | 56601 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Parkland Health Center-Bonne Terre | Bonne Terre | Missouri | 63628 | United States |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | United States |
| Southeast Cancer Center | Cape Girardeau | Missouri | 63703 | United States |
| Capital Region Southwest Campus | Jefferson City | Missouri | 65109 | United States |
| Mercy Hospital Joplin | Joplin | Missouri | 64804 | United States |
| Delbert Day Cancer Institute at PCRMC | Rolla | Missouri | 65401 | United States |
| Mercy Clinic-Rolla-Cancer and Hematology | Rolla | Missouri | 65401 | United States |
| Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri | 63670 | United States |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | United States |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | United States |
| Saint Louis Cancer and Breast Institute-South City | St Louis | Missouri | 63109 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | United States |
| Missouri Baptist Sullivan Hospital | Sullivan | Missouri | 63080 | United States |
| Missouri Baptist Outpatient Center-Sunset Hills | Sunset Hills | Missouri | 63127 | United States |
| Saint Patrick Hospital - Community Hospital | Missoula | Montana | 59802 | United States |
| Women's Cancer Center of Nevada | Las Vegas | Nevada | 89169 | United States |
| Cooper Hospital University Medical Center | Camden | New Jersey | 08103 | United States |
| MD Anderson Cancer Center at Cooper-Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| Women's Cancer Care Associates LLC | Albany | New York | 12208 | United States |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | United States |
| AdventHealth Hendersonville | Hendersonville | North Carolina | 28792 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | 58501 | United States |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | United States |
| Sanford Clinic North-Fargo | Fargo | North Dakota | 58122 | United States |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58122 | United States |
| Summa Health System - Akron Campus | Akron | Ohio | 44304 | United States |
| UHHS-Chagrin Highlands Medical Center | Beachwood | Ohio | 44122 | United States |
| University of Cincinnati Cancer Center-UC Medical Center | Cincinnati | Ohio | 45219 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Grandview Hospital | Dayton | Ohio | 45405 | United States |
| Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | 44124 | United States |
| UHHS-Westlake Medical Center | Westlake | Ohio | 44145 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Oklahoma Cancer Specialists and Research Institute-Tulsa | Tulsa | Oklahoma | 74146 | United States |
| Saint Charles Health System | Bend | Oregon | 97701 | United States |
| Clackamas Radiation Oncology Center | Clackamas | Oregon | 97015 | United States |
| Providence Cancer Institute Clackamas Clinic | Clackamas | Oregon | 97015 | United States |
| Bay Area Hospital | Coos Bay | Oregon | 97420 | United States |
| Providence Newberg Medical Center | Newberg | Oregon | 97132 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Saint Charles Health System-Redmond | Redmond | Oregon | 97756 | United States |
| Jefferson Abington Hospital | Abington | Pennsylvania | 19001 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Asplundh Cancer Pavilion | Willow Grove | Pennsylvania | 19090 | United States |
| Women and Infants Hospital | Providence | Rhode Island | 02905 | United States |
| AnMed Health Cancer Center | Anderson | South Carolina | 29621 | United States |
| Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina | 29316 | United States |
| Prisma Health Cancer Institute - Easley | Easley | South Carolina | 29640 | United States |
| Gibbs Cancer Center-Gaffney | Gaffney | South Carolina | 29341 | United States |
| Greenville Health System Cancer Institute-Andrews | Greenville | South Carolina | 29601 | United States |
| Saint Francis Hospital | Greenville | South Carolina | 29601 | United States |
| Prisma Health Cancer Institute - Butternut | Greenville | South Carolina | 29605 | United States |
| Prisma Health Cancer Institute - Faris | Greenville | South Carolina | 29605 | United States |
| Prisma Health Greenville Memorial Hospital | Greenville | South Carolina | 29605 | United States |
| Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | 29615 | United States |
| Prisma Health Cancer Institute - Greer | Greer | South Carolina | 29650 | United States |
| Gibbs Cancer Center-Pelham | Greer | South Carolina | 29651 | United States |
| Prisma Health Cancer Institute - Seneca | Seneca | South Carolina | 29672 | United States |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota | 57104 | United States |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | United States |
| Parkland Memorial Hospital | Dallas | Texas | 75235 | United States |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | United States |
| Memorial Hermann Texas Medical Center | Houston | Texas | 77030 | United States |
| Providence Regional Cancer System-Aberdeen | Aberdeen | Washington | 98520 | United States |
| PeaceHealth Saint Joseph Medical Center | Bellingham | Washington | 98225 | United States |
| Providence Regional Cancer System-Centralia | Centralia | Washington | 98531 | United States |
| Swedish Cancer Institute-Edmonds | Edmonds | Washington | 98026 | United States |
| Providence Regional Cancer Partnership | Everett | Washington | 98201 | United States |
| Swedish Cancer Institute-Issaquah | Issaquah | Washington | 98029 | United States |
| Kadlec Clinic Hematology and Oncology | Kennewick | Washington | 99336 | United States |
| Providence Regional Cancer System-Lacey | Lacey | Washington | 98503 | United States |
| PeaceHealth Saint John Medical Center | Longview | Washington | 98632 | United States |
| Pacific Gynecology Specialists | Seattle | Washington | 98104 | United States |
| Swedish Medical Center-Ballard Campus | Seattle | Washington | 98107 | United States |
| Kaiser Permanente Washington | Seattle | Washington | 98112 | United States |
| Swedish Medical Center-First Hill | Seattle | Washington | 98122-4307 | United States |
| Swedish Medical Center-Cherry Hill | Seattle | Washington | 98122-5711 | United States |
| PeaceHealth United General Medical Center | Sedro-Woolley | Washington | 98284 | United States |
| Providence Regional Cancer System-Shelton | Shelton | Washington | 98584 | United States |
| MultiCare Deaconess Cancer and Blood Specialty Center - Downtown | Spokane | Washington | 99204 | United States |
| MultiCare Deaconess Cancer and Blood Specialty Center - North | Spokane | Washington | 99218 | United States |
| MultiCare Deaconess Cancer and Blood Specialty Center - Valley | Spokane Valley | Washington | 99216 | United States |
| PeaceHealth Southwest Medical Center | Vancouver | Washington | 98664 | United States |
| Providence Saint Mary Regional Cancer Center | Walla Walla | Washington | 99362 | United States |
| Providence Regional Cancer System-Yelm | Yelm | Washington | 98597 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Eligible and treated
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GEM+CIS+IMRT | Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Race (NIH/OMB) | 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 | Complete Pathologic Response | Percentage of participants with complete pathologic response. Complete pathologic response is defined as negative local core biopsy or FNA specimens following primary chemo-radiation therapy. | Eligible and treated | Posted | Number | 90% Confidence Interval | percentage of participants | 6 -8 weeks after completion of chemo-radiation |
|
|
| |||||||||||||||||||||||||
| Secondary | Complete Clinical Response | Percentage of participants with complete clinical response. Complete clinical response is defined as no clinical/radiographic evidence of primary disease (vulva or groin) following primary chemo-radiation therapy. | Eligible and Treated | Posted | Number | 90% Confidence Interval | percentage of participants | 6-8 weeks after completion of chemo-radiation |
|
| ||||||||||||||||||||||||||
| Secondary | Adverse Events (Grade 3 or Higher) During Treatment Period | Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0. | Eligible and Treated | Posted | Count of Participants | Participants | During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months. |
|
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | Estimate for probability of progression free survival by Kaplan-Meier method, where progression-free survival is defined as the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. PFS is censored in patients who are alive and have not progressed. Progression is assessed by RECIST 1.1 | Eligible and treated | Posted | Number | 90% Confidence Interval | percentage of participants | From study entry to disease progression, death or date of last contact, whichever occurs first. The median for observed PFS was 26.2 month with a range from 1.5 months to 82.4 months |
|
|
During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GEM+CIS+IMRT | Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes. | 1 | 53 | 24 | 53 | 53 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastrointestinal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sudden Death Nos | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lung Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vascular Access Complication | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Platelet Count Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| White Blood Cell Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Muscle Weakness Lower Limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Reproductive System And Breast Disorders - Other | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood And Lymphatic System Disorders - Other | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mobitz Type I | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinus Bradycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chest Pain - Cardiac | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blurred Vision | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Floaters | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anal Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mucositis Oral | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lower Gastrointestinal Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastrointestinal Disorders - Other | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gingival Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rectal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hemorrhoidal Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| General Disorders And Administration Site Conditio | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Malaise | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Localized Edema | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Edema Limbs | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Allergic Reaction | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Infections And Infestations - Other | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vulval Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hepatitis Viral | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vaginal Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vascular Access Complication | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dermatitis Radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Burn | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Investigations - Other | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Weight Loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Platelet Count Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Creatinine Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| White Blood Cell Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alkaline Phosphatase Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Metabolism And Nutrition Disorders - Other | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Muscle Weakness Lower Limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Tumor Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cognitive Disturbance | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urine Discoloration | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary Urgency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary Tract Obstruction | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary Tract Pain | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary Frequency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cystitis Noninfective | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chronic Kidney Disease | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bladder Spasm | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vaginal Pain | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vaginal Hemorrhage | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Perineal Pain | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vaginal Discharge | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vaginal Inflammation | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Genital Edema | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin And Subcutaneous Tissue Disorders - Other | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin Ulceration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rash Acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain Of Skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nail Loss | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Erythroderma | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Surgical And Medical Procedures - Other | Surgical and medical procedures | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thromboembolic Event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Superficial Thrombophlebitis | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphedema | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hot Flashes | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Gedeon for Wei Deng | NRG Oncology | 716-845-1169 | linda.gedeon@roswellpark.org |
| Oct 20, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014846 | Vulvar Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| C044245 | 1,2-diaminocyclohexaneplatinum II citrate |
| D010984 | Platinum |
| D000093542 | Gemcitabine |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D028561 | Transition Elements |
| D008670 | Metals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 50 - 59 years |
|
| 60 - 69 years |
|
| 70 - 79 years |
|
| >= 80 years |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|