TriangleNCT00087698 · STUDY IN CONTEXT
Phase II Trial of Neo-Adjuvant Pemetrexed Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Number of participants with results of pathological review that indicated a complete response. Pathological complete response should be evaluated at the time of surgery (Extrapleural Pneumonectomy \[EPP\]). Resected tissue or pleural fluid should be sent for pathological and histological evaluation.
Kaplan-Meier estimates of the percentage of participants still alive at 1-year and 2-years, based upon the total number of participants who had surgery.
The frequency of best overall tumor response summarized by response category. The best (unconfirmed) response recorded from the start of chemotherapy treatment until disease progression/recurrence, start of any further anti-tumor therapy, or time of surgery whichever comes first.
Time to relapse (treatment failure) is measured in months and calculated as (Date of first surgery - Date of first relapse after surgery + 1)/(365.25/12). Time to relapse will be censored at the date of the last visit or start date of further anti-tumor therapy or intervention, whichever comes first.
Number of months between the first dose date and the date of first disease progression or death as a result of any cause, whichever comes first.
Number of months between the first dose date and the date of death as a result of any cause. Overall survival time calculated as (Date of death - First dose date + 1)/(365.25/12).
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT00087698
- trial label
- Phase II Trial of Neo-Adjuvant Pemetrexed Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT00087698
- outcome key
- om-0000
- source section id
- NCT00087698-om-0000
- source outcome index
- 0
- endpoint
- Pathological Complete Response
- endpoint definition
- Number of participants with results of pathological review that indicated a complete response. Pathological complete response should be evaluated at the time of surgery (Extrapleural Pneumonectomy \[EPP\]). Resected tissue or pleural fluid should be sent for pathological and histological evaluation.
- time origin
- Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who had undergone surgery.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT00087698
- outcome key
- om-0001
- source section id
- NCT00087698-om-0001
- source outcome index
- 1
- endpoint
- The 1 and 2 Year Disease-Free Survival Rate (Percentage)
- endpoint definition
- Kaplan-Meier estimates of the percentage of participants still alive at 1-year and 2-years, based upon the total number of participants who had surgery.
- time origin
- 1 year and 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who had undergone surgery.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT00087698
- outcome key
- om-0002
- source section id
- NCT00087698-om-0002
- source outcome index
- 2
- endpoint
- Overall Tumor Response
- endpoint definition
- The frequency of best overall tumor response summarized by response category. The best (unconfirmed) response recorded from the start of chemotherapy treatment until disease progression/recurrence, start of any further anti-tumor therapy, or time of surgery whichever comes first.
- time origin
- baseline to measured progressive disease
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intention to Treat analysis. All enrolled participants who were eligible for the treatment, whether or not they received the study drug.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT00087698
- outcome key
- om-0003
- source section id
- NCT00087698-om-0003
- source outcome index
- 3
- endpoint
- Time to Treatment Failure
- endpoint definition
- Time to relapse (treatment failure) is measured in months and calculated as (Date of first surgery - Date of first relapse after surgery + 1)/(365.25/12). Time to relapse will be censored at the date of the last visit or start date of further anti-tumor therapy or intervention, whichever comes first.
- time origin
- baseline to stopping treatment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who had undergone surgery.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT00087698
- outcome key
- om-0004
- source section id
- NCT00087698-om-0004
- source outcome index
- 4
- endpoint
- Time to Progressive Disease
- endpoint definition
- Number of months between the first dose date and the date of first disease progression or death as a result of any cause, whichever comes first.
- time origin
- baseline to measured progressive disease
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who had undergone surgery.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT00087698
- outcome key
- om-0005
- source section id
- NCT00087698-om-0005
- source outcome index
- 5
- endpoint
- Overall Survival Time
- endpoint definition
- Number of months between the first dose date and the date of death as a result of any cause. Overall survival time calculated as (Date of death - First dose date + 1)/(365.25/12).
- time origin
- baseline to date of death from any cause
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who had undergone surgery.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT00087698
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Pemetrexed
- regimen
- 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)
- analyzed count
- 57
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00087698-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT00087698
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Pemetrexed
- regimen
- 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)
- analyzed count
- 57
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00087698-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT00087698
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Pemetrexed
- regimen
- 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)
- analyzed count
- 77
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00087698-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT00087698
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Pemetrexed
- regimen
- 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)
- analyzed count
- 57
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00087698-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT00087698
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Pemetrexed
- regimen
- 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)
- analyzed count
- 57
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00087698-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT00087698
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Pemetrexed
- regimen
- 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)
- analyzed count
- 57
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00087698-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-thoracic-neoplasm
- nct id
- NCT00087698
- harm key
- EG000
- source section id
- NCT00087698-ae
- event group key
- EG000
- event group label
- Pemetrexed
- serious affected
- Source null
- serious at risk
- Source null
- other affected
- Source null
- other at risk
- Source null
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Source null
- undenominated note
- 15 affected by a serious event, reported without a group denominator; 77 affected by a non-serious event, reported without a group denominator
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice