Not provided
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Due to low accrual
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Recent studies have shown that the chance of survival among women with advanced cervical cancer is increased when they receive concurrent chemotherapy and radiation to the pelvis. However, patients who have advanced disease show loco-regional failure as well as a high incidence of distant metastasis. Positron emission tomography (PET) scanning has high sensitivity and specificity in the detection of pelvic and para-aortic lymph node metastases. While the detection of para-aortic metastases by PET significantly impacts prognosis, PET has been known to show positive lymph node metastasis in the pelvis only while not detecting micrometastatic disease in the para-aortic lymph nodes (despite the fact that they are histologically known).
In addition, patients with positive para-aortic lymph nodes on PET, greater amounts (more than 45 Gy) of radiation must be used to improve the probability of controlling the cancer. However, doses greater than this have been limited because of the dose and volume limits to the small bowel. But, Intensity Modulated Radiation Therapy (IMRT) is a new way of calculating and delivering radiation therapy. Compared to external beam radiation, IMRT has the improved ability to deliver large doses of radiation to specific targets while minimizing the exposure to surrounding normal tissue.
With IMRT, however, the effective dose/volume can be increased more safely and lower the toxicity of surrounding tissue, thus making prophylactic dosing to para-aortic lymph nodes not detected by PET safer and more effective.
Prior to entrance on the study, patients will undergo a history and physical and evaluation of Karnofsky Performance Status. They will have a biopsy of their tumor and will undergo a fluorodeoxyglucose (FDG) PET scan and must include evaluation of para-aortic lymph nodes. Blood work will be done (complete blood count (CBC), differential, platelets, blood urea nitrogen(BUN), serum creatinine, bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase. Also, pre-treatment, patients will receive a chest x-ray and an intravenous push (IVP) (unless a computed tomography (CT) with contrast has been performed). Additionally, patient may undergo a CT, magnetic resonance (MRI) and/or lymphangiogram.
Patients will then be registered to a treatment arm, depending on the outcome of their PET scan. Patients with positive pelvic lymph nodes but no positive para-aortic lymph nodes by PET will be assigned to Treatment Arm 1. Patients with positive pelvic lymph nodes and positive para-aortic lymph nodes by PET will be assigned to treatment arm 2.
Treatment Group 1. Either a conventional or CT simulation may be performed. Patients will be treated with IMRT extended field external beam radiation therapy (to cover pelvis and para-aortic lymph nodes) and intracavitary radiation (6 high dose radiation (HDR) treatments) concurrently with cisplatin (40 mg/m^2/week)
Treatment Group 2. A CT simulation must be performed. Patients will be treated with extended field external beam radiation therapy to the pelvis and with IMRT to cover the para-aortic lymph nodes to 60 Gy, 50.4 Gy to the para-aortic lymph node bed in conjunction with external beam pelvic radiation therapy as appropriate for disease stage and intracavitary radiation (6 HDR treatments) concurrently with cisplatin (40 mg/m^2/week).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Experimental | Pelvic Lymph Nodes Only Positive on FDG PET. IMRT External Beam radiation to the para-aortic region (45 Gy) Pelvis intracavitary brachytherapy (6 HDR treatments) Weekly cisplatin 40 mg/m^2 |
|
| Treatment Group 2 | Experimental | Para-Aortic Lymph Nodes Positive on FDG PET IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes) IMRT external beam pelvic radiation therapy as appropriate for stage Intracavitary brachytherapy (6 HDR treatments) Weekly cisplatin (40 mg/m^2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMRT extended field external beam radiation therapy | Radiation |
| ||
| Brachytherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity | -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting. | 1 year post start of radiation therapy |
| Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher) | 30 days after completion of radiation therapy | |
| Efficacy of IMRT Extended-field Radiation Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by PET Scan Disease Status | 1st PET scan after completion of treatment (approximately month 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of IMRT to the Para-aortic Lymph Nodes, IMRT External Beam Radiotherapy to the Pelvis, Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by the Frequency of Distant Metastasis | 5 years after completion of radiation therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Perry Grigsby, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
Not provided
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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Not provided
The study opened to patient accrual on 05/01/2003 and closed to patient accrual on 04/24/2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | Pelvic Lymph Nodes Only Positive on fluorodeoxyglucose (FDG) positron emission tomography (PET). Intensity-modulated radiation therapy (IMRT) External Beam radiation to the para-aortic region (45 Gy) Pelvis intracavitary brachytherapy (6 high dose radiation (HDR) treatments) Weekly cisplatin 40 mg/m^2 |
| FG001 | Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | Para-Aortic Lymph Nodes Positive on FDG PET IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes) IMRT external beam pelvic radiation therapy as appropriate for stage Intracavitary brachytherapy (6 HDR treatments) Weekly cisplatin (40 mg/m^2) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | Pelvic Lymph Nodes Only Positive on FDG PET. IMRT External Beam radiation to the para-aortic region (45 Gy) Pelvis intracavitary brachytherapy (6 HDR treatments) Weekly cisplatin 40 mg/m^2 |
| BG001 | Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity | -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting. | Posted | Number | participants | 1 year post start of radiation therapy |
|
Not provided
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
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 | Treatment Group 1 (IMRT, Brachytherapy, Cisplatin) | Pelvic Lymph Nodes Only Positive on FDG PET. IMRT External Beam radiation to the para-aortic region (45 Gy) Pelvis intracavitary brachytherapy (6 HDR treatments) Weekly cisplatin (40 mg/m^2) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Perry Grigsby, M.D. | Washington University School of Medicine | 314-362-8502 | grigsby@radonc.wustl.edu |
Not provided
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
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Not provided
| Radiation |
|
| Cisplatin | Drug |
|
| Poor performance status |
|
| Non-compliant |
|
| Did not sign consent form |
|
| Did not receive chemo per protocol |
|
Para-Aortic Lymph Nodes Positive on FDG PET IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes) IMRT external beam pelvic radiation therapy as appropriate for stage Intracavitary brachytherapy (6 HDR treatments) Weekly cisplatin (40 mg/m^2) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Para-Aortic Lymph Nodes Positive on FDG PET IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes) IMRT external beam pelvic radiation therapy as appropriate for stage Intracavitary brachytherapy (6 HDR treatments) Weekly cisplatin (40 mg/m^2) |
|
|
| Primary | Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher) | Posted | Number | participants | 30 days after completion of radiation therapy |
|
|
|
| Primary | Efficacy of IMRT Extended-field Radiation Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by PET Scan Disease Status | Posted | Number | participants | 1st PET scan after completion of treatment (approximately month 6) |
|
|
|
| Secondary | Efficacy of IMRT to the Para-aortic Lymph Nodes, IMRT External Beam Radiotherapy to the Pelvis, Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by the Frequency of Distant Metastasis | The data was not collected for this secondary outcome. Due to the the early termination of this study, only data for the primary outcomes were collected and analyzed. | Posted | 5 years after completion of radiation therapy |
|
|
| 10 |
| 41 |
| 41 |
| 41 |
| EG001 | Treatment Group 2 (IMRT, Brachytherapy, Cisplatin) | Para-Aortic Lymph Nodes Positive on FDG PET IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes) IMRT external beam pelvic radiation therapy as appropriate for stage Intracavitary brachytherapy (6 HDR treatments) Weekly cisplatin (40 mg/m^2) | 4 | 20 | 20 | 20 |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection without neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutropenia (ANC) | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Radiation dermatitis | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Skin pain | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Polymicrobial sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Absolute neutrophil count (ANC) | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| Albumin | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| BUN | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bilirubin | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| CO2 (elevated) | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Cardiac dysrhythmias | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chest pain | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chloride | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Creatinine | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dermatologic (vaginal mucosa erythematous) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Granulocytes/Bands | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hematologic - other (RBCs) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hematologic - other (hematocrit) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage (rectal bleeding) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage (vaginal bleeding) | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hemorrhagic cystitis | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperproteinemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypobilirubinemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Infection (Respiratory) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection (urinalysis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection with neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| LDH | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Leucocyte esterase | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Neuro-mood | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| PRBC Transfusion | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| PT | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| PTT | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Pain NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Plasma Protein | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| SGOT | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| SGPT | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sun intolerance | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (2.0) | Systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Dermatologic (local) | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dyphagia/esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| ESR | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Gastrointestinal (heartburn) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| INR | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Memory loss | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Yeast infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| 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 |
| D017672 |
| Nitrogen Compounds |
| D017671 | Platinum Compounds |
| Anxiety |
|
| Diarrhea |
|
| Dyspnea |
|
| Dysuria |
|
| Fatigue |
|
| Granulocytes/bands |
|
| Hemoglobin |
|
| Hematocrit |
|
| Vaginal bleeding |
|
| Hyperglycemia |
|
| Hypermagnesemia |
|
| Hypertension |
|
| Hypocalcemia |
|
| Hypokalemia |
|
| Hyponatremia |
|
| Hypomagnesemia |
|
| Infection with neutropenia |
|
| Infection (Urinalysis) |
|
| Leukopenia |
|
| Lymphopenia |
|
| Nausea |
|
| Abdominal pain |
|
| Pelvic pain |
|
| Pain - not otherwise specified (NOS) |
|
| packed red blood cell (PRBC) Transfusion |
|
| Platelets |
|
| Proteinuria |
|
| Skin |
|
| Vomiting |
|
| Weight loss |
|
| Albumin |
|
| Atrial fibrillation |
|
| Confusion |
|
| Creatinine |
|
| Vaginal mucosa erythematous |
|
| Edema |
|
| erythrocyte sedimentation rate (ESR) |
|
| Hyperkalemia |
|
| Hypoglycemia |
|
| international normalized ratio (INR) |
|
| Leucocyte esterase |
|
| Prothrombin time (PT) |
|
| partial thromboplastin time (PTT) |
|
| Renal failure |
|
| aspartate aminotransferase (ALT) |
|
| Yeast infection |
|
| Equivocal PET scan |
|
| PET scan not performed |
|