TriangleNCT02454972 · OUTCOME
Response by Investigator Assessment
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 the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)
What was measured
When response is the primary endpoint, and thus all patients must have measurable disease to enter the trial, all patients included in the study must be accounted for in the report of the results, even if there are major protocol treatment deviations or if they are not evaluable. Each patient will be assigned one of the following: Complete Response: Disappearance of all target lesions; Partial Response: ≥30% decrease in the sum of the longest diameters of target lesions; Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions; diameter recorded or the appearance of one or more new lesions; Stable Disease: Neither PR or PD; Inevaluable for response: specify reasons (for example: early death, malignant disease, toxicity; tumour assessments not repeated/incomplete; other). Normally, all eligible patients should be included in the denominator for the calculation of the response rate for phase II trials.
Analysis population: Treated patients with disease measurement
Groups in this outcome
Biliary Tract Carcinoma Cohort
Patients with Pathologically proven diagnosis of biliary tract carcinoma
Carcinoma of Unknown Primary Site Cohort
Patients with pathologically proven diagnosis of carcinoma of unknown primary site
Endometrial Carcinoma Cohort
Patients with pathologically proven diagnosis of endometrial carcinoma
Ewing's Family of Tumors Cohort
Patients with pathologically proven diagnosis of Ewing's Family of Tumors
Germ Cell Tumors Cohort
Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.
Head and Neck Carcinoma Cohort
Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
BRCA1/2-associated Metastatic Breast Carcinoma Cohort
Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
Neuroendocrine Tumors Cohort
Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.
Small Cell Lung Cancer Cohort
Patients with pathologically proven diagnosis of small cell lung cancer
| Group | Source count |
|---|---|
| Biliary Tract Carcinoma Cohort | 18 |
| Carcinoma of Unknown Primary Site Cohort | 19 |
| Endometrial Carcinoma Cohort | 71 |
| Ewing's Family of Tumors Cohort | 28 |
| Germ Cell Tumors Cohort | 23 |
| Head and Neck Carcinoma Cohort | 13 |
| BRCA1/2-associated Metastatic Breast Carcinoma Cohort | 21 |
| Neuroendocrine Tumors Cohort | 31 |
| Small Cell Lung Cancer Cohort | 105 |
Reported measurements
Source class 1
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Biliary Tract Carcinoma Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| Carcinoma of Unknown Primary Site Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| Endometrial Carcinoma Cohort | 2 | Not reported | Not reported | Not reported | Not reported |
| Ewing's Family of Tumors Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| Germ Cell Tumors Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| Head and Neck Carcinoma Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| BRCA1/2-associated Metastatic Breast Carcinoma Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| Neuroendocrine Tumors Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| Small Cell Lung Cancer Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Biliary Tract Carcinoma Cohort | 1 | Not reported | Not reported | Not reported | Not reported |
| Carcinoma of Unknown Primary Site Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| Endometrial Carcinoma Cohort | 6 | Not reported | Not reported | Not reported | Not reported |
| Ewing's Family of Tumors Cohort | 4 | Not reported | Not reported | Not reported | Not reported |
| Germ Cell Tumors Cohort | 1 | Not reported | Not reported | Not reported | Not reported |
| Head and Neck Carcinoma Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| BRCA1/2-associated Metastatic Breast Carcinoma Cohort | 6 | Not reported | Not reported | Not reported | Not reported |
| Neuroendocrine Tumors Cohort | 2 | Not reported | Not reported | Not reported | Not reported |
| Small Cell Lung Cancer Cohort | 38 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Biliary Tract Carcinoma Cohort | 5 | Not reported | Not reported | Not reported | Not reported |
| Carcinoma of Unknown Primary Site Cohort | 11 | Not reported | Not reported | Not reported | Not reported |
| Endometrial Carcinoma Cohort | 29 | Not reported | Not reported | Not reported | Not reported |
| Ewing's Family of Tumors Cohort | 12 | Not reported | Not reported | Not reported | Not reported |
| Germ Cell Tumors Cohort | 8 | Not reported | Not reported | Not reported | Not reported |
| Head and Neck Carcinoma Cohort | 3 | Not reported | Not reported | Not reported | Not reported |
| BRCA1/2-associated Metastatic Breast Carcinoma Cohort | 10 | Not reported | Not reported | Not reported | Not reported |
| Neuroendocrine Tumors Cohort | 9 | Not reported | Not reported | Not reported | Not reported |
| Small Cell Lung Cancer Cohort | 34 | Not reported | Not reported | Not reported | Not reported |
Progressive disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Biliary Tract Carcinoma Cohort | 11 | Not reported | Not reported | Not reported | Not reported |
| Carcinoma of Unknown Primary Site Cohort | 7 | Not reported | Not reported | Not reported | Not reported |
| Endometrial Carcinoma Cohort | 30 | Not reported | Not reported | Not reported | Not reported |
| Ewing's Family of Tumors Cohort | 9 | Not reported | Not reported | Not reported | Not reported |
| Germ Cell Tumors Cohort | 12 | Not reported | Not reported | Not reported | Not reported |
| Head and Neck Carcinoma Cohort | 8 | Not reported | Not reported | Not reported | Not reported |
| BRCA1/2-associated Metastatic Breast Carcinoma Cohort | 5 | Not reported | Not reported | Not reported | Not reported |
| Neuroendocrine Tumors Cohort | 18 | Not reported | Not reported | Not reported | Not reported |
| Small Cell Lung Cancer Cohort | 28 | Not reported | Not reported | Not reported | Not reported |
Inevaluable for response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Biliary Tract Carcinoma Cohort | 1 | Not reported | Not reported | Not reported | Not reported |
| Carcinoma of Unknown Primary Site Cohort | 1 | Not reported | Not reported | Not reported | Not reported |
| Endometrial Carcinoma Cohort | 4 | Not reported | Not reported | Not reported | Not reported |
| Ewing's Family of Tumors Cohort | 3 | Not reported | Not reported | Not reported | Not reported |
| Germ Cell Tumors Cohort | 2 | Not reported | Not reported | Not reported | Not reported |
| Head and Neck Carcinoma Cohort | 2 | Not reported | Not reported | Not reported | Not reported |
| BRCA1/2-associated Metastatic Breast Carcinoma Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| Neuroendocrine Tumors Cohort | 2 | Not reported | Not reported | Not reported | Not reported |
| Small Cell Lung Cancer Cohort | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- Complete Response
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 38
- title
- Partial Response
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 29
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 9
- group Id
- OG008
- value
- 34
- title
- Stable Disease
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 30
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 18
- group Id
- OG008
- value
- 28
- title
- Progressive disease
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 5
- title
- Inevaluable for response
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 71
- group Id
- OG003
- value
- 28
- group Id
- OG004
- value
- 23
- group Id
- OG005
- value
- 13
- group Id
- OG006
- value
- 21
- group Id
- OG007
- value
- 31
- group Id
- OG008
- value
- 105
- units
- Participants
- description
- When response is the primary endpoint, and thus all patients must have measurable disease to enter the trial, all patients included in the study must be accounted for in the report of the results, even if there are major protocol treatment deviations or if they are not evaluable. Each patient will be assigned one of the following: Complete Response: Disappearance of all target lesions; Partial Response: ≥30% decrease in the sum of the longest diameters of target lesions; Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions; diameter recorded or the appearance of one or more new lesions; Stable Disease: Neither PR or PD; Inevaluable for response: specify reasons (for example: early death, malignant disease, toxicity; tumour assessments not repeated/incomplete; other). Normally, all eligible patients should be included in the denominator for the calculation of the response rate for phase II trials.
- groups
- description
- Patients with Pathologically proven diagnosis of biliary tract carcinoma
- id
- OG000
- title
- Biliary Tract Carcinoma Cohort
- description
- Patients with pathologically proven diagnosis of carcinoma of unknown primary site
- id
- OG001
- title
- Carcinoma of Unknown Primary Site Cohort
- description
- Patients with pathologically proven diagnosis of endometrial carcinoma
- id
- OG002
- title
- Endometrial Carcinoma Cohort
- description
- Patients with pathologically proven diagnosis of Ewing's Family of Tumors
- id
- OG003
- title
- Ewing's Family of Tumors Cohort
- description
- Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.
- id
- OG004
- title
- Germ Cell Tumors Cohort
- description
- Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
- id
- OG005
- title
- Head and Neck Carcinoma Cohort
- description
- Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
- id
- OG006
- title
- BRCA1/2-associated Metastatic Breast Carcinoma Cohort
- description
- Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.
- id
- OG007
- title
- Neuroendocrine Tumors Cohort
- description
- Patients with pathologically proven diagnosis of small cell lung cancer
- id
- OG008
- title
- Small Cell Lung Cancer Cohort
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Treated patients with disease measurement
- reporting Status
- POSTED
- time Frame
- From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)
- title
- Response by Investigator Assessment
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice