TriangleNCT00095875 · OUTCOME
Overall Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percent of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 3-years
What was measured
To compare the 3-year survival achieved by docetaxel/cisplatin/5-FU based sequential therapy with platinum based chemo radiotherapy in patients with locally advanced SCCHN. Overall survival is defined as the time from date of randomisation to death from any cause. Patients alive at the time of current analysis were censored at the date last known to be alive.Kaplan-Meier method was used to estimate overall survival
Groups in this outcome
Arm I
Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks. cisplatin : Given IV radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks carboplatin : Given IV fluorouracil : Given IV docetaxel : Given IV
Arm II
Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks. cisplatin : Given IV radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks
| Group | Source count |
|---|---|
| Arm I | 70 |
| Arm II | 75 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I | 73 | Not reported | 60 | 82 | Not reported |
| Arm II | 78 | Not reported | 66 | 86 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 60
- upper Limit
- 82
- value
- 73
- group Id
- OG001
- lower Limit
- 66
- upper Limit
- 86
- value
- 78
- denoms
- counts
- group Id
- OG000
- value
- 70
- group Id
- OG001
- value
- 75
- units
- Participants
- description
- To compare the 3-year survival achieved by docetaxel/cisplatin/5-FU based sequential therapy with platinum based chemo radiotherapy in patients with locally advanced SCCHN. Overall survival is defined as the time from date of randomisation to death from any cause. Patients alive at the time of current analysis were censored at the date last known to be alive.Kaplan-Meier method was used to estimate overall survival
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks. cisplatin : Given IV radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks carboplatin : Given IV fluorouracil : Given IV docetaxel : Given IV
- id
- OG000
- title
- Arm I
- description
- Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks. cisplatin : Given IV radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks
- id
- OG001
- title
- Arm II
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 3-years
- title
- Overall Survival
- type
- PRIMARY
- unit Of Measure
- percent of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice