TriangleNCT00807768 · OUTCOME
Patient-reported Neurotoxicity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment.
What was measured
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 suggesting less neurotoxicity.
Analysis population: Provided baseline and ≥ follow-up assessments
Groups in this outcome
Arm I (Pelvic Radiation Therapy)
Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments. 3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Arm II (Brachytherapy, Paclitaxel, Carboplatin)
Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
| Group | Source count |
|---|---|
| Arm I (Pelvic Radiation Therapy) | 263 |
| Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 277 |
Reported measurements
Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Pelvic Radiation Therapy) | 14.6 | 0.2 | Not reported | Not reported | Not reported |
| Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 14.7 | 0.1 | Not reported | Not reported | Not reported |
4 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Pelvic Radiation Therapy) | 14.6 | 0.1 | Not reported | Not reported | Not reported |
| Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 13.0 | 0.2 | Not reported | Not reported | Not reported |
10-11 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Pelvic Radiation Therapy) | 14.2 | 0.1 | Not reported | Not reported | Not reported |
| Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 12.0 | 0.2 | Not reported | Not reported | Not reported |
8 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Pelvic Radiation Therapy) | 14.0 | 0.2 | Not reported | Not reported | Not reported |
| Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 12.7 | 0.2 | Not reported | Not reported | Not reported |
14 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Pelvic Radiation Therapy) | 13.5 | 0.2 | Not reported | Not reported | Not reported |
| Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 12.8 | 0.2 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.2
- value
- 14.6
- group Id
- OG001
- spread
- 0.1
- value
- 14.7
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 0.1
- value
- 14.6
- group Id
- OG001
- spread
- 0.2
- value
- 13.0
- title
- 4 Weeks
- categories
- measurements
- group Id
- OG000
- spread
- 0.1
- value
- 14.2
- group Id
- OG001
- spread
- 0.2
- value
- 12.0
- title
- 10-11 Weeks
- categories
- measurements
- group Id
- OG000
- spread
- 0.2
- value
- 14.0
- group Id
- OG001
- spread
- 0.2
- value
- 12.7
- title
- 8 Months
- categories
- measurements
- group Id
- OG000
- spread
- 0.2
- value
- 13.5
- group Id
- OG001
- spread
- 0.2
- value
- 12.8
- title
- 14 Months
- denoms
- counts
- group Id
- OG000
- value
- 263
- group Id
- OG001
- value
- 277
- units
- Participants
- description
- 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 suggesting less neurotoxicity.
- dispersion Type
- Standard Error
- groups
- description
- Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments. 3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
- id
- OG000
- title
- Arm I (Pelvic Radiation Therapy)
- description
- Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Internal Radiation Therapy: Undergo vaginal cuff brachytherapy Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
- id
- OG001
- title
- Arm II (Brachytherapy, Paclitaxel, Carboplatin)
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Provided baseline and ≥ follow-up assessments
- reporting Status
- POSTED
- time Frame
- Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment.
- title
- Patient-reported Neurotoxicity
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice