TriangleNCT02254278 · OUTCOME
HPV DNA Status by 2-year Local-regional Failure Status
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From end of treatment (approximate 6 weeks) to 2 years
What was measured
Local-regional failure is defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression. Positive HPV DNA status is defined as 5 or more HPV DNA fragments per mL of blood plasma, assessed by tumor-tissue modified viral (TTMV) testing.
Analysis population: Eligible participants with post-treatment HPV DNA value and two-year local-regional failure data (i.e. not censored)
Groups in this outcome
Local-regional Failure at 2 Years = No
Treatment arms are combined: MRT 6 Weeks + Cisplatin arm: Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks; Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy. IMRT 5 weeks arm: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
Local-regional Failure at 2 Years = Yes
Treatment arms are combined: MRT 6 Weeks + Cisplatin arm: Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks; Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy. IMRT 5 weeks arm: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
| Group | Source count |
|---|---|
| Local-regional Failure at 2 Years = No | 120 |
| Local-regional Failure at 2 Years = Yes | 8 |
Reported measurements
Source class 1
HPV DNA Negative
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Local-regional Failure at 2 Years = No | 114 | Not reported | Not reported | Not reported | Not reported |
| Local-regional Failure at 2 Years = Yes | 6 | Not reported | Not reported | Not reported | Not reported |
HPV DNA Positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Local-regional Failure at 2 Years = No | 6 | Not reported | Not reported | Not reported | Not reported |
| Local-regional Failure at 2 Years = Yes | 2 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.08
- statistical Comment
- Two-sided significance level = 0.05
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.08
- statistical Comment
- Two-sided significance level = 0.05
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- value
- 114
- group Id
- OG001
- value
- 6
- title
- HPV DNA Negative
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 2
- title
- HPV DNA Positive
- denoms
- counts
- group Id
- OG000
- value
- 120
- group Id
- OG001
- value
- 8
- units
- Participants
- description
- Local-regional failure is defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression. Positive HPV DNA status is defined as 5 or more HPV DNA fragments per mL of blood plasma, assessed by tumor-tissue modified viral (TTMV) testing.
- groups
- description
- Treatment arms are combined: MRT 6 Weeks + Cisplatin arm: Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks; Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy. IMRT 5 weeks arm: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
- id
- OG000
- title
- Local-regional Failure at 2 Years = No
- description
- Treatment arms are combined: MRT 6 Weeks + Cisplatin arm: Cisplatin: 40 mg/m2 IV (intravenously) weekly for 6 weeks; Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy. IMRT 5 weeks arm: Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
- id
- OG001
- title
- Local-regional Failure at 2 Years = Yes
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Eligible participants with post-treatment HPV DNA value and two-year local-regional failure data (i.e. not censored)
- reporting Status
- POSTED
- time Frame
- From end of treatment (approximate 6 weeks) to 2 years
- title
- HPV DNA Status by 2-year Local-regional Failure Status
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice