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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-08031 | |||
| 2004-004273-28 | EudraCT Number |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a non-randomized, multicenter study.
After completion of study treatment, patients are followed on days 42 and 90, every 3 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| pemetrexed disodium | Drug | |||
| adjuvant therapy | Procedure | |||
| conventional surgery | Procedure | |||
| neoadjuvant therapy | Procedure | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility in terms of 90-day progression-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | ||
| Progression-free survival | ||
| Overall survival |
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DISEASE CHARACTERISTICS:
Histologically confirmed malignant pleural mesothelioma
T1-3, N0-1, M0 disease
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
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
No concurrent immunotherapy
No concurrent routine use of colony-stimulating factors during neoadjuvant chemotherapy
No concurrent secondary prophylactic use of colony-stimulating factors during post-operative radiotherapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Paul Van Schil, MD, PhD | University Hospital, Antwerp | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Antwerpen | Edegem | B-2650 | Belgium | |||
| Istituto Nazionale per la Ricerca sul Cancro |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21684151 | Result | O'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. | |
| 20525721 |
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| Genoa |
| 16132 |
| Italy |
| Azienda Ospedaliera Di Parma | Parma | 43100 | Italy |
| Universita Degli Studi di Udine | Udine | 33100 | Italy |
| Sint Antonius Ziekenhuis | Nieuwegein | 3435 CM | Netherlands |
| Daniel Den Hoed Cancer Center at Erasmus Medical Center | Rotterdam | 3008 AE | Netherlands |
| Princess Royal Hospital at Hull and East Yorkshire NHS Trust | Hull | England | HU8 9HE | United Kingdom |
| Edinburgh Cancer Centre at Western General Hospital | Edinburgh | Scotland | EH4 2XU | United Kingdom |
| Result |
| Van 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. |
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| D054363 | Solitary Fibrous Tumor, Pleural |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D054364 | Solitary Fibrous Tumors |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000068437 | Pemetrexed |
| D017024 | Chemotherapy, Adjuvant |
| D020360 | Neoadjuvant Therapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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