Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02540 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000306463 | |||
| GOG-0204 | Other Identifier | Gynecologic Oncology Group | |
| GOG-0204 | Other Identifier | CTEP | |
| U10CA027469 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
This randomized phase III trial is studying four combination chemotherapy regimens using cisplatin to compare how well they work in treating women with stage IVB, recurrent, or persistent cancer of the cervix. Drugs used in chemotherapy such as cisplatin, paclitaxel, vinorelbine, gemcitabine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen containing cisplatin is most effective in treating cervical cancer.
PRIMARY OBJECTIVES:
I. Compare the survival and response of patients with stage IVB, recurrent, or persistent carcinoma of the cervix when treated with paclitaxel and cisplatin vs vinorelbine and cisplatin vs gemcitabine and cisplatin vs topotecan and cisplatin.
II. Compare the toxic effects of these regimens in these patients. III. Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms.
ARM I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.
ARM II: Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.
ARM III: Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.
ARM IV: Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.
In all arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before courses 2 and 5, and at 9 months after study entry.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (paclitaxel, cisplatin) | Experimental | Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. |
|
| Arm II (vinorelbine, cisplatin) | Experimental | Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. |
|
| Arm III (gemcitabine, cisplatin) | Experimental | Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. |
|
| Arm IV (topotecan, cisplatin) | Experimental | Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Overall Survival (OS) | Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. | Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Response Using RECIST Version 1.0 | RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. |
Not provided
Inclusion Criteria:
Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
Not amenable to curative surgery and/or radiotherapy
At least 1 unidimensionally measurable lesion
No craniospinal metastases
Performance status - GOG 0-1
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Bilirubin no greater than 1.5 times normal
Alkaline phosphatase no greater than 3 times normal
AST no greater than 3 times normal
Creatinine ≤ 1.2 mg/dL
Creatinine > 1.2 mg/dL but < 1.5 mg/dL AND creatinine clearance ≥ 50 mL/min
No bilateral hydronephrosis not alleviated by ureteral stents or percutaneous drainage
Not pregnant or nursing
Fertile patients must use effective contraception
No prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer
No prior malignancy whose treatment contraindicates the current study therapy
No concurrent clinically significant infection
No concurrent cytokines
At least 6 weeks since prior chemoradiotherapy and recovered
No prior chemotherapy (except when concurrently administered with radiotherapy)
At least 3 weeks since prior radiotherapy and recovered
Recovered from prior surgery
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bradley Monk | Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecologic Oncology Group | Philadelphia | Pennsylvania | 19103 | United States |
Until January 2004, the study consisted of only two arms. Interim analysis recommended early closure for futility. 41 patients were enrolled until that point. These 41 patients were excluded from analysis. Two more arms were added and the study re-opened with 4 arms. The 472 patients enrolled after 1/26/2004 were included in analysis.
From May 2003 through April 2007, 513 patients were enrolled. Interim analysis recommended early closure for futility in January 2004.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Paclitaxel, Cisplatin) | Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies |
| FG001 | Arm II (Vinorelbine, Cisplatin) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Gemcitabine Hydrochloride | Drug |
|
|
| Paclitaxel | Drug | Given IV |
|
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Topotecan Hydrochloride | Drug | Given IV |
|
|
| Vinorelbine Tartrate | Drug | Given IV |
|
|
| Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years) |
| Duration of Progression-free Survival (PFS) | Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. | Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years) |
| Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients.consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The score is calculated as the sum of the subscale scores if more than 80% of the FACT-Cx TOI items provide valid answers and all of the component subscales have valid scores. The score ranges 0-116 with a large score suggesting better QOL. | Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1 |
| Pain, Assessed by Brief Pain Inventory | Single item from the Brief Pain Inventory (BPI) assessing "worst pain" in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score. | Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1 |
| Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity. | Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1 |
Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV |
| FG002 | Arm III (Gemcitabine, Cisplatin) | Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies |
| FG003 | Arm IV (Topotecan, Cisplatin) | Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Evaluable (treatment)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Paclitaxel, Cisplatin) | Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies |
| BG001 | Arm II (Vinorelbine, Cisplatin) | Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV |
| BG002 | Arm III (Gemcitabine, Cisplatin) | Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies |
| BG003 | Arm IV (Topotecan, Cisplatin) | Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| 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 | Duration of Overall Survival (OS) | Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. | Evaluable (treatment) | Posted | Median | 95% Confidence Interval | months | Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years) |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Response Using RECIST Version 1.0 | RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. | Evaluable (treatment) | Posted | Count of Participants | Participants | Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Progression-free Survival (PFS) | Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. | Evaluable (treatment) | Posted | Median | 95% Confidence Interval | months | Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients.consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The score is calculated as the sum of the subscale scores if more than 80% of the FACT-Cx TOI items provide valid answers and all of the component subscales have valid scores. The score ranges 0-116 with a large score suggesting better QOL. | Patients who provided baseline and ≥ one follow-up assessments | Posted | Mean | Standard Deviation | units on a scale | Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pain, Assessed by Brief Pain Inventory | Single item from the Brief Pain Inventory (BPI) assessing "worst pain" in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score. | Patients who provided baseline and ≥ one follow-up assessments | Posted | Mean | Standard Deviation | units on a scale | Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity. | Patients who provided baseline and ≥ one follow-up assessments | Posted | Mean | Standard Deviation | units on a scale | Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1 |
|
Assessed every cycle while on treatment, 30 days after the last cycle of treatment , and up to 5 years in follow-up.
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 | Arm I (Paclitaxel, Cisplatin) | Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2. Cisplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies | 42 | 103 | 101 | 103 | ||
| EG001 | Arm II (Vinorelbine, Cisplatin) | Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV | 39 | 108 | 105 | 108 | ||
| EG002 | Arm III (Gemcitabine, Cisplatin) | Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies | 38 | 112 | 109 | 112 | ||
| EG003 | Arm IV (Topotecan, Cisplatin) | Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV | 38 | 111 | 108 | 111 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Transfusion Prbc's | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Thrombosis Embolism | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Ischemia/Cardiac Infarction | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Cardiac Left Ventricular Function | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Other Cardiovascular | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Diarrhea Without Colostomy | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Fistula Rectal/Anal | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Diarrhea With Colostomy | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Fistula Intestinal | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Gi Other | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Fever(No Neutropenia) | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Bone Pain | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Abdominal Pain | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pain Rectal/Perirectal | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pain Other | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Allergic Reaction | Immune system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Febrile With Neutropenia | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection Without Neutropenia | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection With Grade 3/4 Neutropenia | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection No Anc | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Catheter-Related Infection | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection Other | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Other Infection | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Metabolic Other | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Musculoskeletal Other | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Ataxia(Incoordination) | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Cns Cerebrovascular Ischemia | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Speech Impairment | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Creatinine | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Fistula | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Ureteral Obstruction | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Renal/Gu Other | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Other Genitourinary/Renal | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pulmonary Other | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Wound Infectious | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Skin Other | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Prothrombin Time | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hemorrhage With Grade 3/4 Thrombocytopenia | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Melena/Gi Bleeding | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Vaginal Bleeding | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hemoptysis | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rectal Bleeding/Hematochezia | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Other Hemorrhage | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Otherhematologic | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Lymphatics | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Thrombosis Embolism | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Sinus Bradycardia | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Cardiac Left Ventricular Function | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Other Cardiovascular | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Inner Ear/Hearing | Ear and labyrinth disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Other Hearing | Ear and labyrinth disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Endocrine | Endocrine disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Ocular | Eye disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Stomatitis/Pharyngitis | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Other Gastrointestinal | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Other Constitutional | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Myalgia | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Other Pain | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hepatic | Hepatobiliary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Allergic Reaction | Immune system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Other Allergy | Immune system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Febrile With Neutropenia | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Infection Without Neutropenia | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Other Infection | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Metabolic | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Musculoskeletal | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Neuropathy Sensor | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Otherneurologic | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Creatinine | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Other Genitourinary/Renal | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Sexual/Reproductive | Reproductive system and breast disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pulmonary | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Rash Desquamation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Other Dermatologic | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Coagulation | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hemorrhage | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Kuras on behalf of Michael Sill and Helen Huang | NRG Oncology | 716-845-5702 | kurasa@nrgoncology.org |
| 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 |
|---|---|
| D002945 | Cisplatin |
| C044245 | 1,2-diaminocyclohexaneplatinum II citrate |
| D010984 | Platinum |
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| D013660 | Taxes |
| D019772 | Topotecan |
| D000077235 | Vinorelbine |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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 |
|
| OG002 | Arm III (Gemcitabine, Cisplatin) | Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies |
| OG003 | Arm IV (Topotecan, Cisplatin) | Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV |
|
|
| OG002 |
| Arm III (Gemcitabine, Cisplatin) |
Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies |
| OG003 | Arm IV (Topotecan, Cisplatin) | Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV |
|
|
| Arm II (Vinorelbine, Cisplatin) |
Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Vinorelbine Tartrate: Given IV |
| OG002 | Arm III (Gemcitabine, Cisplatin) | Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies |
| OG003 | Arm IV (Topotecan, Cisplatin) | Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV |
|
|
| OG003 |
| Arm IV (Topotecan, Cisplatin) |
Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV |
|
|
| OG002 | Arm III (Gemcitabine, Cisplatin) | Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II. Cisplatin: Given IV Gemcitabine Hydrochloride Quality-of-Life Assessment: Ancillary studies |
| OG003 | Arm IV (Topotecan, Cisplatin) | Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II. Cisplatin: Given IV Quality-of-Life Assessment: Ancillary studies Topotecan Hydrochloride: Given IV |
|
|