Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Pemetrexed	pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)

Participant Flow:   Overall Study

	Pemetrexed
STARTED	77
COMPLETED	41
NOT COMPLETED	36
Lack of Efficacy, Progressive Disease	14
Death from Other Causes	3
Adverse Event	4
Withdrawal by Subject	4
Lack of Efficacy, Physician Perception	3
Protocol Entry Criteria Not Met	2
Clinical Relapse	1
Death from Study Disease	2
Death from Study Drug Toxicity	2
Protocol Violation	1

Reporting Groups

	Description
Pemetrexed	pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)

Baseline Measures

	Pemetrexed
Number of Participants   [units: participants]	77
Age   [units: years] Mean ± Standard Deviation	61.1 ± 9.38
Gender   [units: participants]
Female	21
Male	56
Region of Enrollment   [units: participants]
United States	77
Disease Stage at Time of Study Entry   [units: participants]
Stage IA	3
Stage IB	3
Stage II	33
Stage III	35
Stage IV	1
Unknown/Not Available	2
Eastern Cooperative Oncology Group Performance Status   [units: participants]
0 - Fully active and asymptomatic	28
1 - Ambulatory with symptoms	47
2 - In bed < 50% of time	2
Initial Pathological Diagnosis   [units: participants]
Epithelial Mesothelioma	62
Mixed Cell Mesothelioma	2
Sarcomatoid Mesothelioma	1
Other	12
Race/Ethnicity   [units: participants]
Caucasian	71
African	1
East/Southeast Asian	1
Western Asian	2
Hispanic	2
Time from Initial Pathological Diagnosis to Enrollment   [units: months] Mean ± Standard Deviation	2.19 ± 2.909

1.  Primary:

Pathological Complete Response   [ Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks) ]

2.  Secondary:

The 1 and 2 Year Disease-Free Survival Rate (Percentage)   [ 1 year and 2 years ]

3.  Secondary:

Overall Tumor Response   [ baseline to measured progressive disease ]

4.  Secondary:

Time to Treatment Failure   [ baseline to stopping treatment ]

5.  Secondary:

Time to Progressive Disease   [ baseline to measured progressive disease ]

6.  Secondary:

Overall Survival Time   [ baseline to date of death from any cause ]