Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Recurrent Cervical Carcinoma, Stage IVB Cervical Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGCisplatin
Given IV
DRUGGemcitabine Hydrochloride
DRUGPaclitaxel
Given IV
OTHERQuality-of-Life Assessment
Ancillary studies
DRUGTopotecan Hydrochloride
Given IV
DRUGVinorelbine Tartrate
Given IV
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix * Stage IVB, recurrent, or persistent disease * Not amenable to curative surgery and/or radiotherapy * At least 1 unidimensionally measurable lesion * At least 20 mm by palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan * Biopsy confirmation required if lesion is less than 30 mm * Target lesion must be outside of a previously irradiated field * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Overall Survival (OS) | Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years) | Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Response Using RECIST Version 1.0 | Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years) | 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. |
| Duration of Progression-free Survival (PFS) | Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years) | 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. |
| Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1 | 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. |
| Pain, Assessed by Brief Pain Inventory | Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1 | 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. |
| Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1 | 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. |
Countries
United States
Participant flow
Recruitment details
From May 2003 through April 2007, 513 patients were enrolled. Interim analysis recommended early closure for futility in January 2004.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 103 |
| 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 | 108 |
| 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 | 112 |
| 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 | 111 |
| Total | 434 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Improper prior treatment | 1 | 0 | 0 | 0 |
| Overall Study | No surgery | 0 | 0 | 1 | 0 |
| Overall Study | No tumor | 0 | 0 | 1 | 0 |
| Overall Study | Other reasons | 2 | 2 | 1 | 2 |
| Overall Study | Pathology | 10 | 7 | 3 | 4 |
| Overall Study | Poor risk | 2 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Arm I (Paclitaxel, Cisplatin) | Arm II (Vinorelbine, Cisplatin) | Arm III (Gemcitabine, Cisplatin) | Arm IV (Topotecan, Cisplatin) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 50 years | 49 years | 45 years | 48 years | 48 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 10 Participants | 20 Participants | 19 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants | 90 Participants | 86 Participants | 78 Participants | 329 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants | 8 Participants | 6 Participants | 14 Participants | 40 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 6 Participants | 3 Participants | 4 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 20 Participants | 23 Participants | 17 Participants | 79 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants | 7 Participants | 17 Participants |
| Race (NIH/OMB) White | 75 Participants | 79 Participants | 80 Participants | 82 Participants | 316 Participants |
| Sex: Female, Male Female | 103 Participants | 108 Participants | 112 Participants | 111 Participants | 434 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 101 / 103 | 105 / 108 | 109 / 112 | 108 / 111 |
| serious Total, serious adverse events | 42 / 103 | 39 / 108 | 38 / 112 | 38 / 111 |
Outcome results
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.
Time frame: Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)
Population: Evaluable (treatment)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Paclitaxel, Cisplatin) | Duration of Overall Survival (OS) | 12.87 months |
| Arm II (Vinorelbine, Cisplatin) | Duration of Overall Survival (OS) | 9.99 months |
| Arm III (Gemcitabine, Cisplatin) | Duration of Overall Survival (OS) | 10.28 months |
| Arm IV (Topotecan, Cisplatin) | Duration of Overall Survival (OS) | 10.25 months |
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.
Time frame: Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)
Population: Evaluable (treatment)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Paclitaxel, Cisplatin) | Duration of Progression-free Survival (PFS) | 5.82 months |
| Arm II (Vinorelbine, Cisplatin) | Duration of Progression-free Survival (PFS) | 3.98 months |
| Arm III (Gemcitabine, Cisplatin) | Duration of Progression-free Survival (PFS) | 4.70 months |
| Arm IV (Topotecan, Cisplatin) | Duration of Progression-free Survival (PFS) | 4.57 months |
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.
Time frame: Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)
Population: Evaluable (treatment)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Paclitaxel, Cisplatin) | Frequency of Response Using RECIST Version 1.0 | Stable Disease | 50 Participants |
| Arm I (Paclitaxel, Cisplatin) | Frequency of Response Using RECIST Version 1.0 | Partial Response | 27 Participants |
| Arm I (Paclitaxel, Cisplatin) | Frequency of Response Using RECIST Version 1.0 | Complete Response | 3 Participants |
| Arm I (Paclitaxel, Cisplatin) | Frequency of Response Using RECIST Version 1.0 | Progressive Disease/other | 23 Participants |
| Arm II (Vinorelbine, Cisplatin) | Frequency of Response Using RECIST Version 1.0 | Partial Response | 20 Participants |
| Arm II (Vinorelbine, Cisplatin) | Frequency of Response Using RECIST Version 1.0 | Complete Response | 8 Participants |
| Arm II (Vinorelbine, Cisplatin) | Frequency of Response Using RECIST Version 1.0 | Stable Disease | 46 Participants |
| Arm II (Vinorelbine, Cisplatin) | Frequency of Response Using RECIST Version 1.0 | Progressive Disease/other | 34 Participants |
| Arm III (Gemcitabine, Cisplatin) | Frequency of Response Using RECIST Version 1.0 | Complete Response | 1 Participants |
| Arm III (Gemcitabine, Cisplatin) | Frequency of Response Using RECIST Version 1.0 | Stable Disease | 54 Participants |
| Arm III (Gemcitabine, Cisplatin) | Frequency of Response Using RECIST Version 1.0 | Partial Response | 24 Participants |
| Arm III (Gemcitabine, Cisplatin) | Frequency of Response Using RECIST Version 1.0 | Progressive Disease/other | 33 Participants |
| Arm IV (Topotecan, Cisplatin) | Frequency of Response Using RECIST Version 1.0 | Partial Response | 24 Participants |
| Arm IV (Topotecan, Cisplatin) | Frequency of Response Using RECIST Version 1.0 | Stable Disease | 53 Participants |
| Arm IV (Topotecan, Cisplatin) | Frequency of Response Using RECIST Version 1.0 | Progressive Disease/other | 32 Participants |
| Arm IV (Topotecan, Cisplatin) | Frequency of Response Using RECIST Version 1.0 | Complete Response | 2 Participants |
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.
Time frame: Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
Population: Patients who provided baseline and ≥ one follow-up assessments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Paclitaxel, Cisplatin) | Pain, Assessed by Brief Pain Inventory | 9 months post cycle 1 | 2.3 units on a scale | Standard Deviation 3 |
| Arm I (Paclitaxel, Cisplatin) | Pain, Assessed by Brief Pain Inventory | Pre-cycle 5 | 3.6 units on a scale | Standard Deviation 3.1 |
| Arm I (Paclitaxel, Cisplatin) | Pain, Assessed by Brief Pain Inventory | Baseline | 4.0 units on a scale | Standard Deviation 2.8 |
| Arm I (Paclitaxel, Cisplatin) | Pain, Assessed by Brief Pain Inventory | Pre-cycle 2 | 3.5 units on a scale | Standard Deviation 2.9 |
| Arm II (Vinorelbine, Cisplatin) | Pain, Assessed by Brief Pain Inventory | Pre-cycle 2 | 3.5 units on a scale | Standard Deviation 2.8 |
| Arm II (Vinorelbine, Cisplatin) | Pain, Assessed by Brief Pain Inventory | Baseline | 3.9 units on a scale | Standard Deviation 3.2 |
| Arm II (Vinorelbine, Cisplatin) | Pain, Assessed by Brief Pain Inventory | Pre-cycle 5 | 4.0 units on a scale | Standard Deviation 2.7 |
| Arm II (Vinorelbine, Cisplatin) | Pain, Assessed by Brief Pain Inventory | 9 months post cycle 1 | 3.2 units on a scale | Standard Deviation 2.9 |
| Arm III (Gemcitabine, Cisplatin) | Pain, Assessed by Brief Pain Inventory | Pre-cycle 5 | 3.5 units on a scale | Standard Deviation 3 |
| Arm III (Gemcitabine, Cisplatin) | Pain, Assessed by Brief Pain Inventory | 9 months post cycle 1 | 3.7 units on a scale | Standard Deviation 3 |
| Arm III (Gemcitabine, Cisplatin) | Pain, Assessed by Brief Pain Inventory | Pre-cycle 2 | 3.4 units on a scale | Standard Deviation 3 |
| Arm III (Gemcitabine, Cisplatin) | Pain, Assessed by Brief Pain Inventory | Baseline | 3.3 units on a scale | Standard Deviation 3 |
| Arm IV (Topotecan, Cisplatin) | Pain, Assessed by Brief Pain Inventory | 9 months post cycle 1 | 2.9 units on a scale | Standard Deviation 2.7 |
| Arm IV (Topotecan, Cisplatin) | Pain, Assessed by Brief Pain Inventory | Baseline | 3.6 units on a scale | Standard Deviation 3.3 |
| Arm IV (Topotecan, Cisplatin) | Pain, Assessed by Brief Pain Inventory | Pre-cycle 2 | 3.6 units on a scale | Standard Deviation 3.1 |
| Arm IV (Topotecan, Cisplatin) | Pain, Assessed by Brief Pain Inventory | Pre-cycle 5 | 2.5 units on a scale | Standard Deviation 3 |
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.
Time frame: Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
Population: Patients who provided baseline and ≥ one follow-up assessments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Paclitaxel, Cisplatin) | Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | 9 months post cycle 1 | 11.1 units on a scale | Standard Deviation 5.2 |
| Arm I (Paclitaxel, Cisplatin) | Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | Pre-cycle 5 | 13.1 units on a scale | Standard Deviation 3.5 |
| Arm I (Paclitaxel, Cisplatin) | Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | Baseline | 14.4 units on a scale | Standard Deviation 2.9 |
| Arm I (Paclitaxel, Cisplatin) | Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | Pre-cycle 2 | 14.1 units on a scale | Standard Deviation 3.2 |
| Arm II (Vinorelbine, Cisplatin) | Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | Pre-cycle 2 | 13.3 units on a scale | Standard Deviation 3.6 |
| Arm II (Vinorelbine, Cisplatin) | Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | Baseline | 13.5 units on a scale | Standard Deviation 3.4 |
| Arm II (Vinorelbine, Cisplatin) | Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | 9 months post cycle 1 | 11.4 units on a scale | Standard Deviation 4.7 |
| Arm II (Vinorelbine, Cisplatin) | Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | Pre-cycle 5 | 13.1 units on a scale | Standard Deviation 3.7 |
| Arm III (Gemcitabine, Cisplatin) | Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | Baseline | 14.2 units on a scale | Standard Deviation 2.9 |
| Arm III (Gemcitabine, Cisplatin) | Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | 9 months post cycle 1 | 12.3 units on a scale | Standard Deviation 3.7 |
| Arm III (Gemcitabine, Cisplatin) | Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | Pre-cycle 5 | 14.1 units on a scale | Standard Deviation 3 |
| Arm III (Gemcitabine, Cisplatin) | Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | Pre-cycle 2 | 13.7 units on a scale | Standard Deviation 3.5 |
| Arm IV (Topotecan, Cisplatin) | Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | 9 months post cycle 1 | 13.1 units on a scale | Standard Deviation 3.5 |
| Arm IV (Topotecan, Cisplatin) | Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | Pre-cycle 5 | 14.4 units on a scale | Standard Deviation 3.2 |
| Arm IV (Topotecan, Cisplatin) | Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | Pre-cycle 2 | 14.2 units on a scale | Standard Deviation 3.2 |
| Arm IV (Topotecan, Cisplatin) | Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale). | Baseline | 14.1 units on a scale | Standard Deviation 3.5 |
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.
Time frame: Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
Population: Patients who provided baseline and ≥ one follow-up assessments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Paclitaxel, Cisplatin) | Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | Baseline | 66.6 units on a scale | Standard Deviation 17.6 |
| Arm I (Paclitaxel, Cisplatin) | Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | Pre-cycle 2 | 65.2 units on a scale | Standard Deviation 17.6 |
| Arm I (Paclitaxel, Cisplatin) | Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | Pre-cycle 5 | 70.5 units on a scale | Standard Deviation 16.5 |
| Arm I (Paclitaxel, Cisplatin) | Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | 9 months post cycle 1 | 71.9 units on a scale | Standard Deviation 16.6 |
| Arm II (Vinorelbine, Cisplatin) | Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | Pre-cycle 2 | 65.5 units on a scale | Standard Deviation 15.8 |
| Arm II (Vinorelbine, Cisplatin) | Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | 9 months post cycle 1 | 69.9 units on a scale | Standard Deviation 18.8 |
| Arm II (Vinorelbine, Cisplatin) | Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | Baseline | 69.1 units on a scale | Standard Deviation 18.6 |
| Arm II (Vinorelbine, Cisplatin) | Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | Pre-cycle 5 | 66.6 units on a scale | Standard Deviation 17.4 |
| Arm III (Gemcitabine, Cisplatin) | Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | Pre-cycle 5 | 64.5 units on a scale | Standard Deviation 16.5 |
| Arm III (Gemcitabine, Cisplatin) | Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | 9 months post cycle 1 | 68.6 units on a scale | Standard Deviation 19.5 |
| Arm III (Gemcitabine, Cisplatin) | Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | Baseline | 67.9 units on a scale | Standard Deviation 19.5 |
| Arm III (Gemcitabine, Cisplatin) | Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | Pre-cycle 2 | 65.3 units on a scale | Standard Deviation 18.2 |
| Arm IV (Topotecan, Cisplatin) | Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | 9 months post cycle 1 | 70.9 units on a scale | Standard Deviation 17.9 |
| Arm IV (Topotecan, Cisplatin) | Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | Pre-cycle 5 | 68.4 units on a scale | Standard Deviation 15.5 |
| Arm IV (Topotecan, Cisplatin) | Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | Baseline | 68.1 units on a scale | Standard Deviation 19.2 |
| Arm IV (Topotecan, Cisplatin) | Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) | Pre-cycle 2 | 66.2 units on a scale | Standard Deviation 16.3 |