Clinical trial · Interventional
Extrapleural Pneumonectomy With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate
A Phase II Feasibility Study of Extrapleural Pneumonectomy With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purposes of this study are: to evaluate the effects (good and bad) that administering heated cisplatin into the chest and abdomen cavity following surgical resection has on malignant mesothelioma; to collect data on the toxicity of cisplatin given directly into the chest and abdomen, and the levels of the cisplatin in the body; to determine if this treatment method has the possibility of helping patients with pleural mesothelioma live longer; and to determine if this treatment method can help decrease the rate of local recurrence of mesothelioma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pleural Mesothelioma | Pleural Malignant Mesothelioma | ALIAS | 0.90 |
| Pleural Mesothelioma | Pleural Mesothelial Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Sodium Thiosulfate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To monitor tumor recurrence and patient survival, and compare those results to historic controls.
Secondary outcomes (2)
- measure
- To document the morbidity and mortality of this treatment protocol in this patient population
- timeFrame
- 3 years
- measure
- to evaluate the pharmacokinetics of cisplatin.
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male of non-pregnant female 18 years of age or older * HIstopathologic confirmation of malignant pleural mesothelioma * Ejection fraction \> 45% * Evidence of adequate renal and hepatic function * Grossly normal contralateral pulmonary function with a chest radiograph and chest CT scan that do not show acute infiltrates * FEV1 \> or = to 2.0L on a preoperative pulmonary function test * Karnofsky performance status of 70% or greater Exclusion Criteria: * Extended disease outside the ipsilateral hemithorax as determined by pre-operative radiographs or intraoperative findings * Positive extrapleural nodes as determined by mediastinoscopy * Positive LENIs * Gross disease present within the hemithorax after surgery * Evidence of distant metastases * Severe non-malignant co-morbid disease: uncontrolled angina, myocardial infarction in the past 6 months, renal insufficiency, liver disease, pulmonary hypertension * Presence of active concomitant malignancy * Patients with a psychiatric or addictive disorder which would preclude informed consent * Previous chemotherapy or radiation therapy to treat mesothelioma * Chemotherapy or radiation therapy administered within 3 years for another malignancy
References
Publications (0)
Data not yet available