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| Sponsor: | European Organization for Research and Treatment of Cancer - EORTC |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00227630 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Mesothelioma |
Drug: cisplatin Drug: pemetrexed disodium Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | A Phase II Feasibility Trial of Induction Chemotherapy Followed by Extrapleural Pneumonectomy and Postoperative Radiotherapy in Patients With Malignant Pleural Mesothelioma |
| Estimated Enrollment: | 52 |
| Study Start Date: | July 2005 |
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.
Eligibility| Ages Eligible for Study: | up to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant pleural mesothelioma
T1-3, N0-1, M0 disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
No concurrent routine use of colony-stimulating factors during neoadjuvant chemotherapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| Belgium | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| Italy | |
| Istituto Nazionale per la Ricerca sul Cancro | |
| Genoa, Italy, 16132 | |
| Azienda Ospedaliera Di Parma | |
| Parma, Italy, 43100 | |
| Universita Degli Studi di Udine | |
| Udine, Italy, 33100 | |
| Netherlands | |
| Sint Antonius Ziekenhuis | |
| Nieuwegein, Netherlands, 3435 CM | |
| Daniel Den Hoed Cancer Center at Erasmus Medical Center | |
| Rotterdam, Netherlands, 3008 AE | |
| United Kingdom | |
| Princess Royal Hospital at Hull and East Yorkshire NHS Trust | |
| Hull, England, United Kingdom, HU8 9HE | |
| Edinburgh Cancer Centre at Western General Hospital | |
| Edinburgh, Scotland, United Kingdom, EH4 2XU | |
| Study Chair: | Paul Van Schil, MD, PhD | Universitair Ziekenhuis Antwerpen |
More Information
| ClinicalTrials.gov Identifier: | NCT00227630 History of Changes |
| Other Study ID Numbers: | CDR0000443009, EORTC-08031, EudraCT-2004-004273-28 |
| Study First Received: | September 26, 2005 |
| Last Updated: | December 17, 2011 |
| Health Authority: | United States: Federal Government |
|
epithelial mesothelioma sarcomatous mesothelioma localized malignant mesothelioma recurrent malignant mesothelioma |
|
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Pemetrexed Cisplatin Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |