Clinical trial · Interventional
Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate
A Phase II Feasibility Study of Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate Followed ny Adjuvant ALIMTA/Cisplatin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of acurral
Summary
Brief summary (as posted)
The purposes of this study are: to determine the feasibility of administering adjuvant cisplatin plus ALIMTA to patients who undergo surgery with heated cisplatin during surgery; to determine the effects (good and bad) of this combined modality approach in patients with mesothelioma; to evaluate cisplatin effects by determining where it goes and how it is excreted in the body from the collection of tissues and cisplatin samples; to collect and analyze discarded samples of mesothelioma tumor during surgery to help determine the genetic make-up of the disease.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALIMTA | Drug | Pemetrexed | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Sodium Thiosulfate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Surgery+Heated Cisplatin+Sodium Thiosulfate+Adjuvant CT
- description
- 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.
- interventionNames
- Drug: Cisplatin
- Drug: Sodium Thiosulfate
- Drug: ALIMTA
Primary outcomes (1)
- measure
- Adjuvant Chemotherapy Completion Rate
- timeFrame
- 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.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologic confirmation of malignant pleural mesothelioma * Patients who are able to tolerate surgical cytoreduction but unable to undergo extrapleural pneumonectomy due to poor cardiopulmonary reserve or tumor invasion or those with minimal disease * Male on non-pregnant female * 18 years of age or older * No evidence of spread outside the ipsilateral hemithorax by chest CT and chest MRI * Ejection fraction \> 45% * Pre-operative WBC \> 4K/uL * Estimated life expectancy of at least 12 weeks * Evidence of adequate renal and hepatic function * Grossly normal contralateral pulmonary function with a chest radiograph and chest CT scan * Karnofsky performance status of 70% or greater * No evidence of disease progression by chest CT or chest MRI, obtained at 8 weeks following surgery Exclusion Criteria: * Extended disease outside the ipsilateral hemithorax as determined on pre-operative radiographs or intraoperative findings * Positive extrapleural nodes as determined by mediastinoscopy * Gross disease (estimated thickness \> 10mm at any intrathoracic location) present within the hemithorax after surgery * Evidence of distant metastatic disease * Severe non-malignant co-morbid disease, uncontrolled angina, myocardial infarction on the past 6 months, renal insufficiency, liver disease, pulmonary hypertension * Pregnant or breast-feeding * Serious concomitant systemic disorders * Presence of active concomitant malignancy * Psychiatric or addictive disorders, which would preclude informed consent * Previous chemotherapy or radiation therapy for mesothelioma * Chemotherapy or radiation therapy administered within 3 years for another malignancy
References
Publications (0)
Data not yet available