TriangleNCT04200443 · OUTCOME
Progression-free Survival (PFS)
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
- After the first 12 weeks of therapy
What was measured
Progression will be evaluated in this study using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Per RECIST v1.1 criteria, for target lesions, progression is defined as at least a 20% increase in the sum of the longest diameter or the appearance of one or more new lesions; For non-target lesions, progression is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PFS will be the time from the start of treatment to the time of progression, unequivocal clinical deterioration, or death from any cause. The proportion of patients who had a PFS event was calculated.
Groups in this outcome
Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma
Patients received oral cabozantinib 40 mg (as a starting dose) once per day and temozolomide 150 mg/m² on days 1-5 of a 28-day cycle for cycle one. Starting from cycle two, temozolomide was escalated to 200 mg/m² on days 1-5 of each cycle, if the absolute neutrophil count was more than 1·5 × 10⁹/L and platelet count was more than 100·0 × 10⁹/L. Treatment was continued until disease progression or unacceptable drug-related toxicity.
Cohort 2 - Patients With Other Soft Tissue Sarcomas
Patients with gastrointestinal stromal tumour, dermatofibrosarcoma, alveolar soft part sarcoma, kaposi sarcoma, mixed mesodermal tumour or carcinosarcoma, alveolar and embryonal rhabdomyosarcoma, and low grade sarcomas were not included. Patients received oral cabozantinib 40 mg (as a starting dose) once per day and temozolomide 150 mg/m² on days 1-5 of a 28-day cycle for cycle one. Starting from cycle two, temozolomide was escalated to 200 mg/m² on days 1-5 of each cycle, if the absolute neutrophil count was more than 1·5 × 10⁹/L and platelet count was more than 100·0 × 10⁹/L. Treatment was continued until disease progression or unacceptable drug-related toxicity.
| Group | Source count |
|---|---|
| Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma | 42 |
| Cohort 2 - Patients With Other Soft Tissue Sarcomas | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma | 33 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 - Patients With Other Soft Tissue Sarcomas | 29 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 29
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 30
- units
- Participants
- description
- Progression will be evaluated in this study using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Per RECIST v1.1 criteria, for target lesions, progression is defined as at least a 20% increase in the sum of the longest diameter or the appearance of one or more new lesions; For non-target lesions, progression is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PFS will be the time from the start of treatment to the time of progression, unequivocal clinical deterioration, or death from any cause. The proportion of patients who had a PFS event was calculated.
- groups
- description
- Patients received oral cabozantinib 40 mg (as a starting dose) once per day and temozolomide 150 mg/m² on days 1-5 of a 28-day cycle for cycle one. Starting from cycle two, temozolomide was escalated to 200 mg/m² on days 1-5 of each cycle, if the absolute neutrophil count was more than 1·5 × 10⁹/L and platelet count was more than 100·0 × 10⁹/L. Treatment was continued until disease progression or unacceptable drug-related toxicity.
- id
- OG000
- title
- Cohort 1 - Patients With Unresectable or Metastatic Uterine and Non-uterine Leiomyosarcoma
- description
- Patients with gastrointestinal stromal tumour, dermatofibrosarcoma, alveolar soft part sarcoma, kaposi sarcoma, mixed mesodermal tumour or carcinosarcoma, alveolar and embryonal rhabdomyosarcoma, and low grade sarcomas were not included. Patients received oral cabozantinib 40 mg (as a starting dose) once per day and temozolomide 150 mg/m² on days 1-5 of a 28-day cycle for cycle one. Starting from cycle two, temozolomide was escalated to 200 mg/m² on days 1-5 of each cycle, if the absolute neutrophil count was more than 1·5 × 10⁹/L and platelet count was more than 100·0 × 10⁹/L. Treatment was continued until disease progression or unacceptable drug-related toxicity.
- id
- OG001
- title
- Cohort 2 - Patients With Other Soft Tissue Sarcomas
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- After the first 12 weeks of therapy
- title
- Progression-free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice