TriangleNCT04158141 · OUTCOME
Distant-metastases-free Survival (DMFS)
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 distant failure, death, or last follow-up, whichever occurs first. Maximum follow-up was 25 months.
What was measured
Distant failure (DF) is defined as the appearance of cancer deposits characteristic of metastatic dissemination from mesothelioma. DMFS was to be estimated by the Kaplan-Meier method and arms were to be compared using a log-rank test. Analysis was to occur when at least 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 failure at time of study termination is reported, and no statistical testing was done.
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) | 5 | 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
- 5
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Distant failure (DF) is defined as the appearance of cancer deposits characteristic of metastatic dissemination from mesothelioma. DMFS was to be estimated by the Kaplan-Meier method and arms were to be compared using a log-rank test. Analysis was to occur when at least 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 failure at time of study termination is reported, and no statistical testing was done.
- 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 distant failure, death, or last follow-up, whichever occurs first. Maximum follow-up was 25 months.
- title
- Distant-metastases-free Survival (DMFS)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice