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NCT04158141 · OUTCOME

Number of Patients With Grade 3 or Higher Treatment-related Adverse Event After Randomization

Testing the Addition of Targeted Radiation Therapy to Surgery and the Usual Chemotherapy Treatment (Pemetrexed and Cisplatin [or Carboplatin]) for Stage I-IIIA Malignant Pleural Mesothelioma · Source last updated 2026-07-13

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 death or last follow-up. Maximum follow-up time was 25 months.

What was measured

Common Terminology Criteria for Adverse Events (version 5.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Adverse events reported as possibly, probably, or definitely related to treatment are considered to be treatment-related adverse events.

Analysis population: Randomized patients who received protocol treatment and were assessed for adverse events. Arms determined by Step 2 treatment received (as-treated).

Groups in this outcome

Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)

\[As-treated\] 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)

\[As-treated\] 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)6
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)4

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)0Not reportedNot reportedNot reportedNot reported
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      4
    units
    Participants
description
Common Terminology Criteria for Adverse Events (version 5.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Adverse events reported as possibly, probably, or definitely related to treatment are considered to be treatment-related adverse events.
groups
  1. description
    \[As-treated\] 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)
  2. description
    \[As-treated\] 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 who received protocol treatment and were assessed for adverse events. Arms determined by Step 2 treatment received (as-treated).
reporting Status
POSTED
time Frame
From randomization to death or last follow-up. Maximum follow-up time was 25 months.
title
Number of Patients With Grade 3 or Higher Treatment-related Adverse Event After Randomization
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice