Clinical trial · Interventional
Combination Chemotherapy With or Without Surgery & Chemoradiotherapy in Patients With Malignant Pleural Mesothelioma
Aggressive Multi-Modality Management of 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 methotrexate, vinorelbine, 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. Cisplatin may also make tumor cells more sensitive to radiation therapy. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving combination chemotherapy with or without surgery and chemoradiotherapy 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 (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
| Adjuvant therapy | Procedure | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Conventional surgery | Procedure | — | UNRESOLVED |
| Intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Neoadjuvant Therapy | Procedure | — | UNRESOLVED |
| Vinorelbine ditartrate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Induction Combination Chemotherapy
- description
- Induction chemotherapy: Patients get MVP chemo. Treatment repeats every 28 days for 2 courses. Patients w/ unresectable disease may get up to 2 add'l courses of induction chemo. Patients requiring palliative radiotherapy or have PD are removed from study. Patients w/ resectable disease or sarcomatoid histology \& T1-3, N1-2 disease w/ a CR or PR to induction chemo go to surgery. Surgery: Patients w/ extensive disease get palliative debulking pleurectomy and decortication \& are taken off study. Other patients undergo a thoracotomy w/ extrapleural pneumonectomy \& proceed to chemoradiotherapy. Chemoradiotherapy: At 6-10 weeks post-op, patients get 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients receive cisplatin IV over 30-60 minutes days 1 \& 22. Patients w/ responding disease proceed to adjuvant chemotherapy. Adjuvant chemotherapy: Patients get 2 more courses of MVP chemotherapy
- interventionNames
- Drug: Cisplatin
- Drug: Methotrexate
- Drug: Vinorelbine ditartrate
- Procedure: Adjuvant therapy
- Procedure: Conventional surgery
- Procedure: Neoadjuvant Therapy
- Radiation: 3-dimensional conformal radiation therapy
- Radiation: Intensity-modulated radiation therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed malignant pleural mesothelioma
* Amenable to aggressive surgical resection, if deemed resectable
* Patients with potentially resectable disease must have undergone mediastinoscopy to establish surgical stage
* Resectable disease is defined as any of the following:
* Epithelioid, mixed histology, or histology not otherwise specified with clinical stage I-III (T1-3, N0-2, M0) disease
* Sarcomatoid histology with clinical stage I-III (T1-3, N0) disease
* Intraperitoneal extension, contralateral thoracic extension, or distant metastases are eligible, but considered unresectable
* Disease considered unresectable by any medical reason or if surgery was declined
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* WBC ≥ 3,000/mm³
* Platelet count \> 100,000/mm³
* Creatinine ≤ 1.7 mg/dL
* Alkaline phosphatase \< 2 times normal
* AST \< 2 times normal
* Albumin \> 3 g/dL
* Bilirubin \< 2.0 mg/dL
* Patients must be available for and compliant with adequate long-term follow-up
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* Patients with resectable disease must have adequate pulmonary function to undergo surgery and radiotherapy
* No other active malignancies
PRIOR CONCURRENT THERAPY:
* No prior surgical resection, radiation therapy, chemotherapy, or immunotherapy for this cancerReferences
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