Combination Chemotherapy With or Without Surgery & Chemoradiotherapy in Patients With Malignant Pleural Mesothelioma
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 6 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jul 15, 2025 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- The Cleveland Clinic
- Interventions being studied
- 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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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 cancer
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Case Comprehensive Cancer CenterCleveland, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 15, 2025. Always confirm current availability with the study team.