TriangleNCT00936936 · OUTCOME
Overall Survival
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
- 1 year post treatment
What was measured
Number of Participants alive and disease free 1 year post treatment completion.
Groups in this outcome
Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg. HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0.
Cohort 2: HD GeM-DMC+ ICE for Refractory GCT
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0.
| Group | Source count |
|---|---|
| Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | 41 |
| Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | 23 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT | 25 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: HD GeM-DMC+ ICE for Refractory GCT | 9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 9
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 23
- units
- Participants
- description
- Number of Participants alive and disease free 1 year post treatment completion.
- groups
- description
- First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg. HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0.
- id
- OG000
- title
- Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT
- description
- First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0.
- id
- OG001
- title
- Cohort 2: HD GeM-DMC+ ICE for Refractory GCT
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 1 year post treatment
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice