NCT04158141 · BASELINE

Baseline characteristics

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.

denoms

counts
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
16
units
Participants

groups

description
Patients that did not continue to Step 2 (were not randomized). STEP 1: 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.
id
BG000
title
Step 1 Only
description
STEP 1: 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: Patients receive no treatment.
id
BG001
title
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
description
STEP 1: Same as Arm 1. STEP 2: 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
BG002
title
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
description
Total of all reporting groups
id
BG003
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
2
title
≤ 49 years
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
1
group Id
BG003
value
3
title
50 - 59 years
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
group Id
BG003
value
4
title
60 - 69 years
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
2
group Id
BG003
value
7
title
≥ 70 years
denoms
counts
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
16
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
5
group Id
BG003
value
15
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
1
group Id
BG003
value
1
title
Male
denoms
counts
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
16
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
2
title
Hispanic or Latino
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
5
group Id
BG003
value
14
title
Not Hispanic or Latino
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
16
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
1
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
2
group Id
BG003
value
3
title
Black or African American
measurements
group Id
BG000
value
5
group Id
BG001
value
2
group Id
BG002
value
4
group Id
BG003
value
11
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
1
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
16
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
2
group Id
BG003
value
7
title
0
measurements
group Id
BG000
value
2
group Id
BG001
value
3
group Id
BG002
value
4
group Id
BG003
value
9
title
1
denoms
counts
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
16
units
Participants
description
0 = Asymptomatic; 1 = Symptomatic but completely ambulatory; 2 = Symptomatic, \<50% in bed during the day; 3 = Symptomatic, \>50% in bed, but not bedbound; 4 = Bedbound; 5 = Death
param Type
COUNT_OF_PARTICIPANTS
title
Eastern Cooperative Oncology Group (ECOG) Performance Status at Registration
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
4
title
Biphasic mesothelioma
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
5
group Id
BG003
value
12
title
Epithelioid
denoms
counts
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
16
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Cell type
unit Of Measure
Participants
classes
categories
measurements
group Id
BG001
value
1
group Id
BG002
value
3
group Id
BG003
value
4
title
R0 (Complete resection)
measurements
group Id
BG001
value
3
group Id
BG002
value
3
group Id
BG003
value
6
title
R1 (Macroscopically complete resection)
measurements
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
1
title
R2 (Resection that leaves gross tumor behind)
denoms
counts
group Id
BG000
value
0
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
11
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
This is only a baseline characteristic for Step 2, because surgery occurs during Step 1.
title
Macroscopic complete resection in Step 1
unit Of Measure
Participants
classes
categories
measurements
group Id
BG001
value
1
group Id
BG002
value
2
group Id
BG003
value
3
denoms
counts
group Id
BG000
value
0
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
11
units
Participants
title
< 10 pleurectomy/decortations
categories
measurements
group Id
BG001
value
4
group Id
BG002
value
4
group Id
BG003
value
8
denoms
counts
group Id
BG000
value
0
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
11
units
Participants
title
≥ 10 pleurectomy/decortations
description
The yearly number of pleurectomy/decortication procedures performed at the treatment center where the patient underwent this procedure. This data is only a reported baseline measure for Step 2.
param Type
COUNT_OF_PARTICIPANTS
population Description
This data is only a reported baseline measure for Step 2.
title
Yearly procedure volume at the patient's treatment center
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
0
group Id
BG003
value
3
title
IA (T1N0M0)
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
4
group Id
BG003
value
7
title
IIA (T2bN0M0)
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
4
title
IIB (T[1-2]N1M0,T3N0M0)
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
group Id
BG003
value
2
title
IIIA (T[1-2]N2M0) (T3N1M0) (T4N[0-1]M0)
denoms
counts
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
16
units
Participants
description
Overall cancer stage per American Joint Committee on Cancer (AJCC) 8th ed. combines tumor (T), regional lymph node (N), and distant metastasis (M) staging to determine an overall stage of 0, I, II, III, or IV, ranging from least to most advanced, respectively, with patients within the same stage sharing a similar prognosis. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. The higher the number after the N, the greater the involvement of regional lymph nodes. M0 indicates no distant metastasis.
param Type
COUNT_OF_PARTICIPANTS
title
Pathologic AJCC Stage
unit Of Measure
Participants

population Description

Not randomized: Eligible registered patients who did not continue to Step 2 (randomization). Arm 1 and Arm 2: Eligible randomized patients.

Complete source fields

denoms

counts
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
16
units
Participants

groups

description
Patients that did not continue to Step 2 (were not randomized). STEP 1: 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.
id
BG000
title
Step 1 Only
description
STEP 1: 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: Patients receive no treatment.
id
BG001
title
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
description
STEP 1: Same as Arm 1. STEP 2: 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
BG002
title
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
description
Total of all reporting groups
id
BG003
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
2
title
≤ 49 years
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
1
group Id
BG003
value
3
title
50 - 59 years
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
group Id
BG003
value
4
title
60 - 69 years
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
2
group Id
BG003
value
7
title
≥ 70 years
denoms
counts
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
16
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
5
group Id
BG003
value
15
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
1
group Id
BG003
value
1
title
Male
denoms
counts
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
16
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
2
title
Hispanic or Latino
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
5
group Id
BG003
value
14
title
Not Hispanic or Latino
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
16
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
1
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
2
group Id
BG003
value
3
title
Black or African American
measurements
group Id
BG000
value
5
group Id
BG001
value
2
group Id
BG002
value
4
group Id
BG003
value
11
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
1
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
16
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
2
group Id
BG003
value
7
title
0
measurements
group Id
BG000
value
2
group Id
BG001
value
3
group Id
BG002
value
4
group Id
BG003
value
9
title
1
denoms
counts
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
16
units
Participants
description
0 = Asymptomatic; 1 = Symptomatic but completely ambulatory; 2 = Symptomatic, \<50% in bed during the day; 3 = Symptomatic, \>50% in bed, but not bedbound; 4 = Bedbound; 5 = Death
param Type
COUNT_OF_PARTICIPANTS
title
Eastern Cooperative Oncology Group (ECOG) Performance Status at Registration
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
4
title
Biphasic mesothelioma
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
5
group Id
BG003
value
12
title
Epithelioid
denoms
counts
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
16
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Cell type
unit Of Measure
Participants
classes
categories
measurements
group Id
BG001
value
1
group Id
BG002
value
3
group Id
BG003
value
4
title
R0 (Complete resection)
measurements
group Id
BG001
value
3
group Id
BG002
value
3
group Id
BG003
value
6
title
R1 (Macroscopically complete resection)
measurements
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
1
title
R2 (Resection that leaves gross tumor behind)
denoms
counts
group Id
BG000
value
0
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
11
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
This is only a baseline characteristic for Step 2, because surgery occurs during Step 1.
title
Macroscopic complete resection in Step 1
unit Of Measure
Participants
classes
categories
measurements
group Id
BG001
value
1
group Id
BG002
value
2
group Id
BG003
value
3
denoms
counts
group Id
BG000
value
0
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
11
units
Participants
title
< 10 pleurectomy/decortations
categories
measurements
group Id
BG001
value
4
group Id
BG002
value
4
group Id
BG003
value
8
denoms
counts
group Id
BG000
value
0
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
11
units
Participants
title
≥ 10 pleurectomy/decortations
description
The yearly number of pleurectomy/decortication procedures performed at the treatment center where the patient underwent this procedure. This data is only a reported baseline measure for Step 2.
param Type
COUNT_OF_PARTICIPANTS
population Description
This data is only a reported baseline measure for Step 2.
title
Yearly procedure volume at the patient's treatment center
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
0
group Id
BG003
value
3
title
IA (T1N0M0)
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
4
group Id
BG003
value
7
title
IIA (T2bN0M0)
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
4
title
IIB (T[1-2]N1M0,T3N0M0)
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
group Id
BG003
value
2
title
IIIA (T[1-2]N2M0) (T3N1M0) (T4N[0-1]M0)
denoms
counts
group Id
BG000
value
5
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
16
units
Participants
description
Overall cancer stage per American Joint Committee on Cancer (AJCC) 8th ed. combines tumor (T), regional lymph node (N), and distant metastasis (M) staging to determine an overall stage of 0, I, II, III, or IV, ranging from least to most advanced, respectively, with patients within the same stage sharing a similar prognosis. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. The higher the number after the N, the greater the involvement of regional lymph nodes. M0 indicates no distant metastasis.
param Type
COUNT_OF_PARTICIPANTS
title
Pathologic AJCC Stage
unit Of Measure
Participants

population Description

Not randomized: Eligible registered patients who did not continue to Step 2 (randomization). Arm 1 and Arm 2: Eligible randomized patients.

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Preserved source evidence · Not medical advice