TriangleNCT00165503 · STUDY IN CONTEXT
Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate
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
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-malignant-mesothelioma
- nct id
- NCT00165503
- trial label
- Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate
- 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
- 1
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT00165503
- outcome key
- om-0000
- source section id
- NCT00165503-om-0000
- source outcome index
- 0
- endpoint
- Adjuvant Chemotherapy Completion Rate
- endpoint definition
- Feasibility in this study was based on the adjuvant chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of cisplatin and Alimta beginning 6-10 weeks after surgery with hyperthermic cisplatin.
- time origin
- Given the 21-day cycle, 3 cycles of adjuvant chemotherapy approximates 9 weeks in addition to the time from registration and post-surgery which was up to 10 weeks.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- None of the enrolled participants were evaluated for the primary endpoint since none received the experimental adjuvant chemotherapy per protocol.
- 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-malignant-mesothelioma
- nct id
- NCT00165503
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Surgery+Heated Cisplatin+Sodium Thiosulfate+Adjuvant CT
- regimen
- Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours. The adjuvant chemotherapy regimen beginning 6-10 weeks after surgery is a combination of cisplatin and Alimta each given day 1 of a 21-day cycle for 3 cycles.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00165503-om-0000#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT00165503
- harm key
- EG000
- source section id
- NCT00165503-ae
- event group key
- EG000
- event group label
- Surgery + Heated Cisplatin Lavage + Sodium Thiosulfate
- serious affected
- 5
- serious at risk
- 16
- other affected
- 0
- other at risk
- 16
- frequency threshold
- 0
- collection period
- The period for reporting adverse events were 30 days from the participant's date of surgery.
- event definition
- Source null
- undenominated note
- Source null
- 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