Clinical trial · Interventional
Pemetrexed Disodium and Cisplatin Followed by Surgery With or Without Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma
Neoadjuvant Chemotherapy and Extrapleural Pneumonectomy of Malignant Pleural Mesothelioma (MPM) With or Without Hemithoracic Radiotherapy. A Randomized Multicenter Phase II Trial
- 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)
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium together with cisplatin followed by surgery with or without radiation therapy works in treating patients with malignant pleural mesothelioma.
Conditions
Conditions (1)
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 Mesothelioma | Malignant Mesothelioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- No radiotherapy
- interventionNames
- Drug: Cisplatin
- Drug: Pemetrexed
- Procedure: Therapeutic conventional surgery
- type
- EXPERIMENTAL
- label
- Radiotherapy
- interventionNames
- Drug: Cisplatin
- Drug: Pemetrexed
- Procedure: Therapeutic conventional surgery
- Radiation: Radiotherapy
Primary outcomes (2)
- measure
- Complete macroscopic resection (part 1)
- timeFrame
- After surgery (15 weeks after trial registration)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed malignant pleural mesothelioma * T1-3, N0-2, M0 disease according to International Mesothelioma Interest Group staging system * No obvious invasion of mediastinal structures by CT scan (e.g., heart, aorta, spine, esophagus) * No obvious widespread chest wall invasion * Resectable chest wall lesions allowed PATIENT CHARACTERISTICS: * WHO performance score 0-1 * Fit for neoadjuvant therapy, surgery, and postoperative radiotherapy * Creatinine clearance \> 60 mL/min * Hemoglobin ≥ 10.0 g/dL * WBC ≥ 3,500/mm³ * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 1.5 times ULN * Alkaline phosphatase ≤ 1.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for up to 12 months after completion of study treatment * FEV\_1 ≥ 40% of predicted based on spirometry and lung perfusion scan, if necessary * No serious underlying medical condition that would preclude study requirements (e.g., active autoimmune disease or uncontrolled diabetes) * No known hypersensitivity against pemetrexed disodium, cisplatin, or other platinum-containing substances or any other components used for the preparation of the drugs * No restricted power of hearing (especially in the upper frequency range) * No acute infections PRIOR CONCURRENT THERAPY: * No prior chemotherapy * No treatment on another clinical trial within the past 30 days * No prior pleurectomy or lung resection * No prior radiotherapy of the lower neck, thorax, or upper abdomen * No aspirin, cyclooxygenase-2 inhibitors, or nonsteroidal anti-inflammatory agents for 5 days prior to, during, and for 2 days after pemetrexed disodium administration * No other concurrent experimental drugs or anticancer therapy * No concurrent drugs that would contraindicate study drugs * No concurrent vaccination against yellow fever
References
Publications (1)
- RESULTStahel RA, Riesterer O, Xyrafas A, Opitz I, Beyeler M, Ochsenbein A, Fruh M, Cathomas R, Nackaerts K, Peters S, Mamot C, Zippelius A, Mordasini C, Caspar CB, Eckhardt K, Schmid RA, Aebersold DM, Gautschi O, Nagel W, Topfer M, Krayenbuehl J, Ribi K, Ciernik IF, Weder W. Neoadjuvant chemotherapy and extrapleural pneumonectomy of malignant pleural mesothelioma with or without hemithoracic radiotherapy (SAKK 17/04): a randomised, international, multicentre phase 2 trial. Lancet Oncol. 2015 Dec;16(16):1651-8. doi: 10.1016/S1470-2045(15)00208-9. Epub 2015 Nov 2. PMID 26538423