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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000654709 | |||
| NCI-2011-01973 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| RTOG 0724/GOG-0724 | Other Identifier | NRG Oncology |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| NRG Oncology | OTHER |
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RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without additional chemotherapy in treating cervical cancer.
PURPOSE: This randomized phase III trial is studying chemotherapy and pelvic radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk early-stage cervical cancer after radical hysterectomy.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to planned use of brachytherapy (no vs. yes), radiotherapy modality - [standard external beam radiotherapy (EBRT) vs. intensity-modulated radiotherapy (IMRT)], and radiotherapy dose (45 Gy vs. 50.4 Gy). Patients are randomized to 1 of 2 treatment arms.
NOTE: Some patients may also undergo brachytherapy beginning within 7 days after completion of radiotherapy.
Quality of life is assessed by the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group (FACT-GOG/NTX4), FACT-Cx, and FACIT-D questionnaires at baseline; at the completion of chemoradiotherapy; and then at 6, 12, and 24 months after completion of chemoradiotherapy.
Blood and tissue samples may be collected for gene expression analysis by immuno-histochemistry (IHC) and for biomarker and polymorphism studies.
After completion of study treatment, patients are followed up very 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I: Cisplatin/Radiation Therapy | Active Comparator | Standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks as 45 Gy in 25 fractions or 50.4 Gy in 28 fractions (1.8 Gy/fraction). Concurrent cisplatin IV over one hour once weekly for 6 weeks as 40 mg/m^2, maximum dose 70 mg. A brachytherapy boost following radiation therapy is optional. |
|
| Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | Experimental | Chemoradiotherapy as in arm I, followed 4-6 weeks later by paclitaxel IV [135 mg/m2, with maximum body surface area (BSA) of 2.0 m^2 over 3 hours] and carboplatin IV [area under the curve (AUC) 5 over 30 minutes] on day 1 of 21-day cycle for 4 cycles in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | Intravenously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival (Percentage of Participants Alive Without Disease) | Disease-free survival (DFS) is estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. DFS time is measured from the date of randomization to the date of first DFS failure (local, regional or distant metastases failure or death due to any cause) or last follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants. | From randomization to first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Maximum follow-up at the time of analysis was 12.8 years. The 2- and 4-year DFS estimates are reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (Percentage of Participants Alive) | Overall survival is estimated by the Kaplan-Meier method. The distribution of survival estimates between the two arms is compared using the log rank test. Survival time is measured from the date of randomization to the date of death from any cause or last known follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival (Percentage of Participants Alive Without Disease) by Ethnicity | NIH-required analysis. Disease-free survival (DFS) is estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. DFS time is measured from the date of randomization to the date of first DFS failure (local, regional or distant metastases failure or death due to any cause) or last follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants. |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous, adenosquamous, or adenocarcinoma of the cervix with any/all of the following high-risk features after surgery:
Positive pelvic nodes
Positive parametrium
Positive para-aortic nodes that have been completely resected and are positron emission tomography (PET)/computed tomography (CT) scan-negative
Clinical stage IA2, IB, or IIA disease (this corresponds to surgical tumor node metastasis (TNM) staging of T1-T2, N1, M0)
Must have undergone radical hysterectomy (open, laparoscopically, or robotic) and staging within the past 70 days
Para-aortic and pelvic node sampling required
No gross residual disease
No neuroendocrine histology
No distant metastases
PATIENT CHARACTERISTICS:
Zubrod performance status 0-1
Absolute neutrophil count (ANC) ≥ 1,800/mm³
Platelets ≥ 100,000/mm³
White blood cell count (WBC) ≥ 4,000/mm³
Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)
Serum creatinine ≤ 1.5 mg/dL
Bilirubin ≤ 1.5 times upper limit of normal
Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) normal
Alkaline phosphatase normal
Known HIV positivity allowed provided cluster of differentiation 4 (CD4) count is ≥ 350/mm³ within the past 14 days
No other invasive malignancy within the past 3 years, except nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
No severe, active co-morbidity, including any of the following:
No prior allergic reaction to carboplatin, paclitaxel, and/or cisplatin
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior systemic chemotherapy for the current cervical cancer
No prior radiotherapy to the pelvis that would result in overlap of radiotherapy fields
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| Name | Affiliation | Role |
|---|---|---|
| Anuja Jhingran, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Providence Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I: Cisplatin/Radiation Therapy | Standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks as 45 Gy in 25 fractions or 50.4 Gy in 28 fractions (1.8 Gy/fraction). Concurrent cisplatin IV over one hour once weekly for 6 weeks as 40 mg/m^2, maximum dose 70 mg. A brachytherapy boost following radiation therapy is optional. |
| 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 | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2022 |
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| cisplatin |
| Drug |
Intravenously |
|
| paclitaxel | Drug | Intravenously |
|
| intensity-modulated radiation therapy | Radiation | Daily fractions |
|
|
| standard external beam radiation therapy | Radiation | Daily fractions |
|
|
| Optional brachytherapy boost | Radiation | Low-dose rate (20-25 Gy single application) or high-dose rate (12-18 Gy 2-3 applications), dependent on external beam dose. |
|
| From randomization to death or last follow-up. Maximum follow-up time at time of analysis was 12.8 years. The 2- and 4-year survival estimates are reported. |
| Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) at 12 Months | The FACT-GOG/NTX4 measures patient-reported symptoms of chemotherapy-induced peripheral neuropathy in cancer patients. Possible scores range from 0 to 16 with higher scores indicating a better condition. Analysis of covariance, using the baseline score as a covariate, will be used to determine if there is a difference between the treatment arms. | Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks) |
| Functional Assessment of Chronic Illness Therapy - Diarrhea (FACIT-D) Diarrhea Subscore at 12 Months | The diarrhea-specific subscore of the FACIT-D measures patient-reported diarrhea symptoms. Possible scores range from 0 to 44 with higher scores indicating a better quality of life. Analysis of covariance, using the baseline score as a covariate, will be used to determine if there is a difference between the treatment arms. | Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks) |
| Functional Assessment of Cancer Therapy - Cervix (FACT-Cx) Cervical Cancer Subscore at 12 Months | The cervical cancer subscore of the FACT-Cx measures patient-reported symptoms and problems related to cervical cancer. Possible scores range from 0 to 60 with higher scores indicating a better quality of life. Analysis of covariance, using the baseline score as a covariate, will be used to determine if there is a difference between the treatment arms. | Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks) |
| Number of Participants by Highest Grade Adverse Event Reported | Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. | From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years. |
| Associations Between Tumor Molecular Signatures, From Fixed Tissue, and Outcomes Such as Adverse Events, Disease Free Survival and Overall Survival | From randomization to last follow-up |
| Associations Between Secreted Factors From Serum and Plasma With Adverse Events or Outcome | From randomization to last follow-up. |
| Associations Between Single Nucleotide Polymorphisms (SNPs) in Genes From Buffy Coat and a Genetic Predisposition to Tumor Formation Itself or a Response to Cytotoxic Therapy | From randomization to last follow-up. |
| From randomization to first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Maximum follow-up at the time of analysis was 12.8 years. The 2- and 4-year DFS estimates are reported. |
| Disease-free Survival (Percentage of Participants Alive Without Disease) by Race | NIH-required analysis. Disease-free survival (DFS) is estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. DFS time is measured from the date of randomization to the date of first DFS failure (local, regional or distant metastases failure or death due to any cause) or last follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants. | From randomization to first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Maximum follow-up at the time of analysis was 12.8 years. The 2- and 4-year DFS estimates are reported. |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | United States |
| Arizona Center for Cancer Care-Peoria | Peoria | Arizona | 85381 | United States |
| Saint Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | 91505 | United States |
| Mercy San Juan Medical Center | Carmichael | California | 95608 | United States |
| City of Hope Medical Center | Duarte | California | 91010 | United States |
| Saint Joseph Hospital - Orange | Orange | California | 92868 | United States |
| Pomona Valley Hospital Medical Center | Pomona | California | 91767 | United States |
| Mercy Cancer Center | Sacramento | California | 95816 | United States |
| Mercy General Hospital Radiation Oncology Center | Sacramento | California | 95819 | United States |
| University of California At San Diego | San Diego | California | 92103 | United States |
| Saint Helena Hospital | St. Helena | California | 94574 | United States |
| Penrose-Saint Francis Healthcare | Colorado Springs | Colorado | 80907 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| The Hospital of Central Connecticut | New Britain | Connecticut | 06050 | United States |
| University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida | 33442 | United States |
| Memorial Healthcare System - Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | United States |
| Jackson Memorial Hospital-Holtz Children's Hospital | Miami | Florida | 33136 | United States |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | United States |
| Baptist Hospital of Miami | Miami | Florida | 33176 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Grady Health System | Atlanta | Georgia | 30303 | United States |
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Memorial Health University Medical Center | Savannah | Georgia | 31403 | United States |
| Saint Joseph's-Candler Health System | Savannah | Georgia | 31405 | United States |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | United States |
| University of Hawaii | Honolulu | Hawaii | 96813 | United States |
| Saint Alphonsus Regional Medical Center | Boise | Idaho | 83706 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Saint Vincent Anderson Regional Hospital/Cancer Center | Anderson | Indiana | 46016 | United States |
| Saint Francis Hospital and Health Centers | Beech Grove | Indiana | 46107 | United States |
| Franciscan Saint Margaret Health-Hammond Campus | Hammond | Indiana | 46320 | United States |
| Franciscan Saint Francis Health-Indianapolis | Indianapolis | Indiana | 46237 | United States |
| Michiana Hematology Oncology PC-Mishawaka | Mishawaka | Indiana | 46545-1470 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Mercy Medical Center - North Iowa | Mason City | Iowa | 50401 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Kansas City Cancer Centers-Southwest | Overland Park | Kansas | 66210 | United States |
| Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| Central Maryland Radiation Oncology in Howard County | Columbia | Maryland | 21044 | United States |
| Holy Cross Hospital | Silver Spring | Maryland | 20910 | United States |
| Hickman Cancer Center | Adrian | Michigan | 49221 | United States |
| Saint John Hospital and Medical Center | Detroit | Michigan | 48236 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| Saint Joseph Mercy Port Huron | Port Huron | Michigan | 48060 | United States |
| Saint John Macomb-Oakland Hospital | Warren | Michigan | 48093 | United States |
| Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Kansas City Cancer Center - South | Kansas City | Missouri | 64131 | United States |
| Kansas City Cancer Centers - North | Kansas City | Missouri | 64154 | United States |
| Kansas City Cancer Center-Lee's Summit | Lee's Summit | Missouri | 64064 | United States |
| Phelps County Regional Medical Center | Rolla | Missouri | 65401 | United States |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | United States |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | United States |
| Saint John's Mercy Medical Center | St Louis | Missouri | 63141 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| The Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Elliot Hospital | Manchester | New Hampshire | 03103 | United States |
| Cooper Hospital University Medical Center | Camden | New Jersey | 08103 | United States |
| Morristown Memorial Hospital | Morristown | New Jersey | 07962 | United States |
| Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County | Mount Holly | New Jersey | 08060 | United States |
| UMDNJ - New Jersey Medical School | Newark | New Jersey | 07103 | United States |
| MD Anderson Cancer Center at Cooper-Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| State University of New York Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Highland Hospital | Rochester | New York | 14620 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Montefiore Medical Center-Weiler Division | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467-2490 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Summa Akron City Hospital/Cooper Cancer Center | Akron | Ohio | 44304 | United States |
| Akron General Medical Center | Akron | Ohio | 44307 | United States |
| Summa Barberton Hospital | Barberton | Ohio | 44203 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Summa Health Center at Lake Medina | Medina | Ohio | 44256 | United States |
| UHHS-Chagrin Highlands Medical Center | Orange | Ohio | 44122 | United States |
| Southern Ohio Medical Center | Portsmouth | Ohio | 45662 | United States |
| Robinson Radiation Oncology | Ravenna | Ohio | 44266 | United States |
| Cancer Care Center, Incorporated | Salem | Ohio | 44460 | United States |
| Ireland Cancer Center at Firelands Regional Medical Center | Sandusky | Ohio | 44870 | United States |
| Flower Hospital | Sylvania | Ohio | 43560 | United States |
| University of Toledo | Toledo | Ohio | 43614 | United States |
| UHHS-Westlake Medical Center | Westlake | Ohio | 44145 | United States |
| Cancer Treatment Center | Wooster | Ohio | 44691 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Delaware County Memorial Hospital | Drexel Hill | Pennsylvania | 19026 | United States |
| Reading Hospital | West Reading | Pennsylvania | 19611 | United States |
| Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Women and Infants Hospital | Providence | Rhode Island | 02905 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Sanford Cancer Center-Oncology Clinic | Sioux Falls | South Dakota | 57104 | United States |
| University of Tennessee - Knoxville | Knoxville | Tennessee | 37920 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Methodist Hospital | Houston | Texas | 77030 | United States |
| Intermountain Medical Center | Murray | Utah | 84157 | United States |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | United States |
| Dixie Medical Center Regional Cancer Center | St. George | Utah | 84770 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima | Washington | 98902 | United States |
| Wheeling Hospital | Wheeling | West Virginia | 26003 | United States |
| Saint Vincent Hospital | Green Bay | Wisconsin | 54301 | United States |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Froedtert and the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Aurora West Allis Medical Center | West Allis | Wisconsin | 53227 | United States |
| McGill University Department of Oncology | Montreal | Quebec | H2W 1S6 | Canada |
| Pamela Youde Nethersole Eastern Hospital | Chai Wan | Hong Kong |
| Seoul National University Bundang Hospital | Seongnam | Kyeonggi-do | 463-707 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Gangnam Severance Hospital | Seoul | 135-720 | South Korea |
| Korea Cancer Center Hospital | Seoul | 139-706 | South Korea |
| FG001 | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | Chemoradiotherapy as in arm I, followed 4-6 weeks later by paclitaxel IV [135 mg/m2, with maximum body surface area (BSA) of 2.0 m^2 over 3 hours] and carboplatin IV [area under the curve (AUC) 5 over 30 minutes] on day 1 of 21-day cycle for 4 cycles in the absence of disease progression or unacceptable toxicity. |
| Eligible |
|
| COMPLETED | Participants contributing data to results are considered to have completed the study. |
|
| NOT COMPLETED |
|
|
Eligible participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm I: Cisplatin/Radiation Therapy | Standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks as 45 Gy in 25 fractions or 50.4 Gy in 28 fractions (1.8 Gy/fraction). Concurrent cisplatin IV over one hour once weekly for 6 weeks as 40 mg/m^2, maximum dose 70 mg. A brachytherapy boost following radiation therapy is optional. |
| BG001 | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | Chemoradiotherapy as in arm I, followed 4-6 weeks later by paclitaxel IV [135 mg/m2, with maximum body surface area (BSA) of 2.0 m^2 over 3 hours] and carboplatin IV [area under the curve (AUC) 5 over 30 minutes] on day 1 of 21-day cycle for 4 cycles in the absence of disease progression or unacceptable toxicity. |
| 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, Customized | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Zubrod performance status | 0 = Asymptomatic; 1 = Symptomatic but completely ambulatory; 2 = Symptomatic, <50% in bed during the day; 3 = Symptomatic, >50% in bed, but not bedbound; 4 = Bedbound; 5 = Death. | Count of Participants | Participants |
| |||||||||||||||
| Hysterectomy Procedure | Count of Participants | Participants |
| ||||||||||||||||
| Histologic Type | A description of a tumor based on how the cancer cells and tissue look under a microscope. | Count of Participants | Participants |
| |||||||||||||||
| Histologic grade | Histologic grade, also known as tumor grade, is a description of a tumor that's based on how abnormal the cancer cells and tissue look under a microscope, and how quickly the cancer cells are likely to grow and spread. It's used to help plan treatment and determine prognosis. | Count of Participants | Participants |
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| FIGO Staging (clinical) [AJCC 6th Edition] | International Federation of Gynecology and Obstetrics (FIGO) staging is a system developed to stage (or measure) cancers that affect the female reproductive system, such as cervical, ovarian, and endometrial cancers. FIGO staging is based on three main factors: the size and extent of the tumor; the involvement of nearby lymph nodes; the presence or absence of distant metastases. The stages are numbered from I to IV, with subcategories represented by letters or numbers, indicating the severity and progression of the cancer, with lower numbers and letters indicating better prognosis. | Count of Participants | Participants |
| |||||||||||||||
| Pathologic T-Stage | Tumor stage per the American Joint Committee on Cancer (AJCC) 6th ed. refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail with additional letters and numbers. | Count of Participants | Participants |
| |||||||||||||||
| Pathologic N-Stage | Regional lymph nodes staging per American Joint Committee on Cancer (AJCC) 6th ed. refers to the number and/or extent of spread of lymph nodes that contain cancer. N0 means lymph nodes aren't involved. A higher number means the cancer is in more lymph nodes, farther away from the original tumor. NX means the lymph nodes cannot be assessed. | Count of Participants | Participants |
| |||||||||||||||
| Pathologic M-Stage | Metastasis stage per the American Joint Committee on Cancer (AJCC) 6th ed. refers to the spread of the cancer to organs and tissues in other parts of the body. M0 = No distant metastasis; M1 = Distant metastasis; MX = Distant metastasis cannot be assessed. | Count of Participants | Participants |
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| Positive Parametrium | Cancer present. | Count of Participants | Participants |
| |||||||||||||||
| Positive Pelvic Nodes | Cancer present. | Count of Participants | Participants |
| |||||||||||||||
| Positive Para-Aortic Nodes | Cancer present. | Count of Participants | Participants |
| |||||||||||||||
| Intention to use brachytherapy | Count of Participants | Participants |
| ||||||||||||||||
| Intended RT Modality | Count of Participants | Participants |
| ||||||||||||||||
| Intended RT Dose | 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 | Disease-free Survival (Percentage of Participants Alive Without Disease) | Disease-free survival (DFS) is estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. DFS time is measured from the date of randomization to the date of first DFS failure (local, regional or distant metastases failure or death due to any cause) or last follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants. | Eligible participants | Posted | Number | 90% Confidence Interval | percentage of participants | From randomization to first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Maximum follow-up at the time of analysis was 12.8 years. The 2- and 4-year DFS estimates are reported. |
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| Secondary | Overall Survival (Percentage of Participants Alive) | Overall survival is estimated by the Kaplan-Meier method. The distribution of survival estimates between the two arms is compared using the log rank test. Survival time is measured from the date of randomization to the date of death from any cause or last known follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants. | Eligible participants | Posted | Number | 90% Confidence Interval | percentage of participants | From randomization to death or last follow-up. Maximum follow-up time at time of analysis was 12.8 years. The 2- and 4-year survival estimates are reported. |
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| Secondary | Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) at 12 Months | The FACT-GOG/NTX4 measures patient-reported symptoms of chemotherapy-induced peripheral neuropathy in cancer patients. Possible scores range from 0 to 16 with higher scores indicating a better condition. Analysis of covariance, using the baseline score as a covariate, will be used to determine if there is a difference between the treatment arms. | Not Posted | Sep 2026 | Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Functional Assessment of Chronic Illness Therapy - Diarrhea (FACIT-D) Diarrhea Subscore at 12 Months | The diarrhea-specific subscore of the FACIT-D measures patient-reported diarrhea symptoms. Possible scores range from 0 to 44 with higher scores indicating a better quality of life. Analysis of covariance, using the baseline score as a covariate, will be used to determine if there is a difference between the treatment arms. | Not Posted | Sep 2026 | Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Functional Assessment of Cancer Therapy - Cervix (FACT-Cx) Cervical Cancer Subscore at 12 Months | The cervical cancer subscore of the FACT-Cx measures patient-reported symptoms and problems related to cervical cancer. Possible scores range from 0 to 60 with higher scores indicating a better quality of life. Analysis of covariance, using the baseline score as a covariate, will be used to determine if there is a difference between the treatment arms. | Not Posted | Sep 2026 | Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants by Highest Grade Adverse Event Reported | Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. | Eligible participants who started protocol treatment and were assessed for adverse events. | Posted | Count of Participants | Participants | From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Associations Between Tumor Molecular Signatures, From Fixed Tissue, and Outcomes Such as Adverse Events, Disease Free Survival and Overall Survival | The protocol did not provide sufficient detail to meet current National Cancer Institute requirements for release of specimens from the NRG Oncology tissue bank for the protocol-specified objective, therefore no assays were performed, and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial. | Posted | From randomization to last follow-up |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Associations Between Secreted Factors From Serum and Plasma With Adverse Events or Outcome | The protocol did not provide sufficient detail to meet current National Cancer Institute requirements for release of specimens from the NRG Oncology tissue bank for the protocol-specified objective, therefore no assays were performed, and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial. | Posted | From randomization to last follow-up. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Associations Between Single Nucleotide Polymorphisms (SNPs) in Genes From Buffy Coat and a Genetic Predisposition to Tumor Formation Itself or a Response to Cytotoxic Therapy | The protocol did not provide sufficient detail to meet current National Cancer Institute requirements for release of specimens from the NRG Oncology tissue bank for the protocol-specified objective, therefore no assays were performed, and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial. | Posted | From randomization to last follow-up. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Disease-free Survival (Percentage of Participants Alive Without Disease) by Ethnicity | NIH-required analysis. Disease-free survival (DFS) is estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. DFS time is measured from the date of randomization to the date of first DFS failure (local, regional or distant metastases failure or death due to any cause) or last follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants. | Eligible participants stratified by ethnicity | Posted | Number | 90% Confidence Interval | percentage of participants | From randomization to first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Maximum follow-up at the time of analysis was 12.8 years. The 2- and 4-year DFS estimates are reported. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Disease-free Survival (Percentage of Participants Alive Without Disease) by Race | NIH-required analysis. Disease-free survival (DFS) is estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. DFS time is measured from the date of randomization to the date of first DFS failure (local, regional or distant metastases failure or death due to any cause) or last follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants. | Eligible participants stratified by race | Posted | Number | 90% Confidence Interval | percentage of participants | From randomization to first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Maximum follow-up at the time of analysis was 12.8 years. The 2- and 4-year DFS estimates are reported. |
|
From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment were assessed for adverse events.
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 | Arm I: Cisplatin/Radiation Therapy | Standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks as 45 Gy in 25 fractions or 50.4 Gy in 28 fractions (1.8 Gy/fraction). Concurrent cisplatin IV over one hour once weekly for 6 weeks as 40 mg/m^2, maximum dose 70 mg. A brachytherapy boost following radiation therapy is optional. | 17 | 109 | 14 | 107 | 103 | 107 |
| EG001 | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | Chemoradiotherapy as in arm I, followed 4-6 weeks later by paclitaxel IV [135 mg/m2, with maximum body surface area (BSA) of 2.0 m^2 over 3 hours] and carboplatin IV [area under the curve (AUC) 5 over 30 minutes] on day 1 of 21-day cycle for 4 cycles in the absence of disease progression or unacceptable toxicity. | 13 | 103 | 25 | 101 | 99 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Colitis | 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 |
| |
| Gastritis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Kidney infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphocele | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth 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 |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anal pain | 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 |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chills | 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 |
| |
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspareunia | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Reproductive system and breast disorders - Other, specify | 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 dryness | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vaginal hemorrhage | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vaginal pain | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphedema | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | NRG Oncology | 2155743208 | seiferheldw@nrgoncology.org |
| Sep 5, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 21, 2022 | Nov 14, 2022 | ICF_000.pdf |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine 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 |
|---|---|
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 |
|
| Laparoscopic |
|
| Robotic |
|
| Adenosquamous carcinoma |
|
| Adenocarcinoma, not otherwise specificed (NOS) |
|
| G1-Well differentiated |
|
| G2-Moderately differentiated |
|
| G3-Poorly differentiated |
|
| IB |
|
| IIA |
|
| T1 |
|
| T1a1 |
|
| T1a2 |
|
| T1b |
|
| T1b1 |
|
| T1b2 |
|
| T2 |
|
| T2b |
|
| T3b |
|
| N1 |
|
| M1 |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Not sampled / dissected |
|
| Yes |
|
| IMRT |
|
| 50.4 Gy |
|
| Superiority |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
| Units | Counts |
|---|
| Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|