TriangleNCT03258554 · OUTCOME
Percentage of Participants With Complete or Partial Response at 4-month Scan Determined by Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline and 4 months after end of RT (approximately 6.5 months)
What was measured
Fludeoxyglucose F-18 positron emission tomography/computed tomography (FDG-PET/CT) scans at baseline and four months after the end of radiation therapy are compared. Per RECIST 1.1: * Complete response: * Disappearance of all lesions and pathologic lymph nodes * Partial response: * ≥ 30% decrease sum of the longest diameters * No new lesions * No progression of non-target lesions
Analysis population: Randomized participants with 4-month response assessed by PET
Groups in this outcome
RT+ Cetuximab
IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.
RT + Durvalumab
IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| RT+ Cetuximab | 22 |
| RT + Durvalumab | 29 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RT+ Cetuximab | 72.7 | Not reported | 51.8 | 86.8 | Not reported |
| RT + Durvalumab | 75.9 | Not reported | 57.9 | 87.8 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 1.00
- p Value 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
- 1.00
- p Value Comment
- Two-sided significance level = 0.05
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 51.8
- upper Limit
- 86.8
- value
- 72.7
- group Id
- OG001
- lower Limit
- 57.9
- upper Limit
- 87.8
- value
- 75.9
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 29
- units
- Participants
- description
- Fludeoxyglucose F-18 positron emission tomography/computed tomography (FDG-PET/CT) scans at baseline and four months after the end of radiation therapy are compared. Per RECIST 1.1: * Complete response: * Disappearance of all lesions and pathologic lymph nodes * Partial response: * ≥ 30% decrease sum of the longest diameters * No new lesions * No progression of non-target lesions
- dispersion Type
- 95% Confidence Interval
- groups
- description
- IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- RT+ Cetuximab
- description
- IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- RT + Durvalumab
- param Type
- NUMBER
- population Description
- Randomized participants with 4-month response assessed by PET
- reporting Status
- POSTED
- time Frame
- Baseline and 4 months after end of RT (approximately 6.5 months)
- title
- Percentage of Participants With Complete or Partial Response at 4-month Scan Determined by Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice