TriangleNCT04158141 · 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
- From randomization to first progression, death, or last follow-up, whichever occurs first. Maximum follow-up was 25 months.
What was measured
Progression is defined as LE, LF, MF, DF, or death. PFS was to be estimated by the Kaplan-Meier method and arms compared by log-rank test. Analysis was to occur when ≥ 105 deaths had been reported. Given the small number of participants due to early study closure, only the number of patients last reported to be alive without progression at study termination is reported, and no statistical testing was done. LE: ≥ 20% increase in the largest diameter (LD) of target lesion from the smallest LD recorded since the treatment start; based on CT scan. LF: Progression of pleural tumor thickness or appearance of a site of pleural thickness \> 5 mm in the site of treated tumor. MF: The appearance of a new measurable site of pleural tumor \> 5mm within the treated site or enlarging tumor dimensions corresponding to a 20% increase in LD compared to initial appearance on imaging evaluation. DF: The appearance of cancer deposits characteristic of metastatic dissemination
Analysis population: Randomized patients
Groups in this outcome
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
\[Intent-to-treat\] STEP 1 (all patients): Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1. STEP 2 (randomized): Patients receive no treatment.
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
\[Intent-to-treat\] STEP 1 (all patients): Same as Arm 1. STEP 2 (randomized): Within 4-8 weeks from the end of Step 1 treatment, patients undergo 25-28 fractions of intensity modulated radiation therapy (IMRT) or pencil beam scanning (PBS) proton therapy 5 days/week over 6 weeks.
| Group | Source count |
|---|---|
| Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment) | 5 |
| Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment) | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS) | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Progression is defined as LE, LF, MF, DF, or death. PFS was to be estimated by the Kaplan-Meier method and arms compared by log-rank test. Analysis was to occur when ≥ 105 deaths had been reported. Given the small number of participants due to early study closure, only the number of patients last reported to be alive without progression at study termination is reported, and no statistical testing was done. LE: ≥ 20% increase in the largest diameter (LD) of target lesion from the smallest LD recorded since the treatment start; based on CT scan. LF: Progression of pleural tumor thickness or appearance of a site of pleural thickness \> 5 mm in the site of treated tumor. MF: The appearance of a new measurable site of pleural tumor \> 5mm within the treated site or enlarging tumor dimensions corresponding to a 20% increase in LD compared to initial appearance on imaging evaluation. DF: The appearance of cancer deposits characteristic of metastatic dissemination
- groups
- description
- \[Intent-to-treat\] STEP 1 (all patients): Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1. STEP 2 (randomized): Patients receive no treatment.
- id
- OG000
- title
- Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
- description
- \[Intent-to-treat\] STEP 1 (all patients): Same as Arm 1. STEP 2 (randomized): Within 4-8 weeks from the end of Step 1 treatment, patients undergo 25-28 fractions of intensity modulated radiation therapy (IMRT) or pencil beam scanning (PBS) proton therapy 5 days/week over 6 weeks.
- id
- OG001
- title
- Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Randomized patients
- reporting Status
- POSTED
- time Frame
- From randomization to first progression, death, or last follow-up, whichever occurs first. Maximum follow-up was 25 months.
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice