Clinical trial · Interventional
Pemetrexed Disodium and Cisplatin Followed By Surgery and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma
A Phase II Feasibility Trial of Induction Chemotherapy Followed by Extrapleural Pneumonectomy and Postoperative Radiotherapy in Patients With Malignant Pleural Mesothelioma
- 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. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and cisplatin followed by surgery and 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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| pemetrexed disodium | Drug | Pemetrexed | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Feasibility in terms of 90-day progression-free survival
Secondary outcomes (3)
- measure
- Toxicity
- measure
- Progression-free survival
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 69 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignant pleural mesothelioma * All subtypes allowed * T1-3, N0-1, M0 disease * No N2 or N3 involvement confirmed by mediastinoscopy within 21 days before study entry * No clinical invasion of mediastinal structures (e.g., heart, aorta, spine, esophagus) * No wide-spread chest wall invasion except focal chest wall lesions * No clinical or radiological evidence of shrinking hemithorax * No clinically significant third-space fluid (e.g., pleural effusions or ascites) that cannot be managed with thoracentesis or pleurodesis PATIENT CHARACTERISTICS: Age * Under 70 Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * WBC \> 3,500/mm\^3 * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin ≥ 11 g/dL Hepatic * AST and ALT \< 1.5 times upper limit of normal (ULN) * Bilirubin \< 1.5 times ULN * Alkaline phosphatase \< 1.5 times ULN Renal * Creatinine clearance ≥ 60 mL/min * Acceptable (predicted) post-radiotherapy renal function by semiquantitative isotope renography, with a relative contribution of the contralateral kidney of ≥ 40% Pulmonary * See Disease Characteristics Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * Deemed to be fit enough to undergo study treatment * No preexisting sensory neurotoxicity \> grade 1 * No uncontrolled infection * No prior or concurrent melanoma, breast cancer, or hypernephroma * No other malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated basal cell skin cancer * No psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy * No concurrent routine use of colony-stimulating factors during neoadjuvant chemotherapy * Concurrent secondary prophylactic use allowed during neoadjuvant chemotherapy * No concurrent secondary prophylactic use of colony-stimulating factors during post-operative radiotherapy Chemotherapy * No prior chemotherapy for mesothelioma Endocrine therapy * No concurrent hormonal cancer therapy Radiotherapy * No prior radiotherapy to the lower neck, thorax, or upper abdomen Surgery * See Disease Characteristics Other * No other concurrent anticancer therapy * No other concurrent experimental medications * No nonsteroidal anti-inflammatory drugs or salicylates for 2 days before, during, and 2 days after administration of neoadjuvant chemotherapy (5 days before and 2 days after for drugs with a long half-life \[e.g., naproxen, piroxicam, diflunisal, or nabumetone\])
References
Publications (2)
- RESULTO'Brien ME, Konopa K, Lorigan P, Bosquee L, Marshall E, Bustin F, Margerit S, Fink C, Stigt JA, Dingemans AM, Hasan B, Van Meerbeeck J, Baas P. Randomised phase II study of amrubicin as single agent or in combination with cisplatin versus cisplatin etoposide as first-line treatment in patients with extensive stage small cell lung cancer - EORTC 08062. Eur J Cancer. 2011 Oct;47(15):2322-30. doi: 10.1016/j.ejca.2011.05.020. Epub 2011 Jun 16. PMID 21684151
- RESULTVan Schil PE, Baas P, Gaafar R, Maat AP, Van de Pol M, Hasan B, Klomp HM, Abdelrahman AM, Welch J, van Meerbeeck JP; European Organisation for Research and Treatment of Cancer (EORTC) Lung Cancer Group. Trimodality therapy for malignant pleural mesothelioma: results from an EORTC phase II multicentre trial. Eur Respir J. 2010 Dec;36(6):1362-9. doi: 10.1183/09031936.00039510. Epub 2010 Jun 4. PMID 20525721