TriangleNCT01898494 · OUTCOME
Progression-free Survival Rate at 2 Years
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Assessed every 3 months for 2 years
What was measured
Progression-free survival is defined as the time from randomization/assignment of post-surgical treatment to the appearance of lesions, including primary, nodal or new site, or death, whichever occurs first. These patients are considered disease-free after surgery so the appearance of any lesions is counted as progression. Kaplan-Meier estimate was used to characterize progression-free survival rate at 2 years.
Analysis population: Eligible and treated patients
Groups in this outcome
Arm S (Surgery) Then Arm A (Low Risk, Observation)
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation.
Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks.
Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive standard-dose IMRT (60 Gy) QD five days a week for 6 weeks.
Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, high risk patients then receive IMRT (66Gy) QD five days a week for 6-7 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
| Group | Source count |
|---|---|
| Arm S (Surgery) Then Arm A (Low Risk, Observation) | 38 |
| Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT) | 100 |
| Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT) | 108 |
| Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy) | 113 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm S (Surgery) Then Arm A (Low Risk, Observation) | 0.969 | Not reported | 0.919 | 1.00 | Not reported |
| Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT) | 0.949 | Not reported | 0.913 | 0.986 | Not reported |
| Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT) | 0.96 | Not reported | 0.928 | 0.993 | Not reported |
| Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy) | 0.907 | Not reported | 0.862 | 0.954 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.919
- upper Limit
- 1.00
- value
- 0.969
- group Id
- OG001
- lower Limit
- 0.913
- upper Limit
- 0.986
- value
- 0.949
- group Id
- OG002
- lower Limit
- 0.928
- upper Limit
- 0.993
- value
- 0.96
- group Id
- OG003
- lower Limit
- 0.862
- upper Limit
- 0.954
- value
- 0.907
- denoms
- counts
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 100
- group Id
- OG002
- value
- 108
- group Id
- OG003
- value
- 113
- units
- Participants
- description
- Progression-free survival is defined as the time from randomization/assignment of post-surgical treatment to the appearance of lesions, including primary, nodal or new site, or death, whichever occurs first. These patients are considered disease-free after surgery so the appearance of any lesions is counted as progression. Kaplan-Meier estimate was used to characterize progression-free survival rate at 2 years.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation.
- id
- OG000
- title
- Arm S (Surgery) Then Arm A (Low Risk, Observation)
- description
- Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks.
- id
- OG001
- title
- Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)
- description
- Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive standard-dose IMRT (60 Gy) QD five days a week for 6 weeks.
- id
- OG002
- title
- Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)
- description
- Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, high risk patients then receive IMRT (66Gy) QD five days a week for 6-7 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
- id
- OG003
- title
- Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)
- param Type
- NUMBER
- population Description
- Eligible and treated patients
- reporting Status
- POSTED
- time Frame
- Assessed every 3 months for 2 years
- title
- Progression-free Survival Rate at 2 Years
- type
- PRIMARY
- unit Of Measure
- proportion of participants
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Preserved source evidence · Not medical advice