Malignant Mesothelioma Clinical Trial
Official title:
Neoadjuvant Chemotherapy and Extrapleural Pneumonectomy of Malignant Pleural Mesothelioma (MPM) With or Without Hemithoracic Radiotherapy. A Randomized Multicenter Phase II Trial
Verified date | May 2019 |
Source | Swiss Group for Clinical Cancer Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. 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. Giving radiation therapy after surgery may kill any tumor cells
that remain after surgery.
PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium
together with cisplatin followed by surgery with or without radiation therapy works in
treating patients with malignant pleural mesothelioma.
Status | Completed |
Enrollment | 153 |
Est. completion date | January 23, 2018 |
Est. primary completion date | March 26, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 69 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed malignant pleural mesothelioma - T1-3, N0-2, M0 disease according to International Mesothelioma Interest Group staging system - No obvious invasion of mediastinal structures by CT scan (e.g., heart, aorta, spine, esophagus) - No obvious widespread chest wall invasion - Resectable chest wall lesions allowed PATIENT CHARACTERISTICS: - WHO performance score 0-1 - Fit for neoadjuvant therapy, surgery, and postoperative radiotherapy - Creatinine clearance > 60 mL/min - Hemoglobin = 10.0 g/dL - WBC = 3,500/mm³ - Absolute neutrophil count = 1,500/mm³ - Platelet count = 100,000/mm³ - Bilirubin = 1.5 times upper limit of normal (ULN) - AST and ALT = 1.5 times ULN - Alkaline phosphatase = 1.5 times ULN - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for up to 12 months after completion of study treatment - FEV_1 = 40% of predicted based on spirometry and lung perfusion scan, if necessary - No serious underlying medical condition that would preclude study requirements (e.g., active autoimmune disease or uncontrolled diabetes) - No known hypersensitivity against pemetrexed disodium, cisplatin, or other platinum-containing substances or any other components used for the preparation of the drugs - No restricted power of hearing (especially in the upper frequency range) - No acute infections PRIOR CONCURRENT THERAPY: - No prior chemotherapy - No treatment on another clinical trial within the past 30 days - No prior pleurectomy or lung resection - No prior radiotherapy of the lower neck, thorax, or upper abdomen - No aspirin, cyclooxygenase-2 inhibitors, or nonsteroidal anti-inflammatory agents for 5 days prior to, during, and for 2 days after pemetrexed disodium administration - No other concurrent experimental drugs or anticancer therapy - No concurrent drugs that would contraindicate study drugs - No concurrent vaccination against yellow fever |
Country | Name | City | State |
---|---|---|---|
Germany | Universitaetsklinikum Freiburg | Freiburg | |
Switzerland | Kantonsspital Aarau | Aarau | |
Switzerland | Kantonsspital Baden | Baden | |
Switzerland | Universitaetsspital-Basel | Basel | |
Switzerland | Inselspital Bern | Bern | |
Switzerland | Spital Tiefenau | Bern 4 | |
Switzerland | Kantonsspital Bruderholz | Bruderholz | |
Switzerland | Kantonsspital Graubuenden | Chur | |
Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne | |
Switzerland | Kantonsspital Olten | Olten | |
Switzerland | Kantonsspital - St. Gallen | St. Gallen | |
Switzerland | SpitalSTS AG Simmental-Thun-Saanenland | Thun | |
Switzerland | UniversitaetsSpital Zuerich | Zurich |
Lead Sponsor | Collaborator |
---|---|
Swiss Group for Clinical Cancer Research |
Germany, Switzerland,
Stahel RA, Riesterer O, Xyrafas A, Opitz I, Beyeler M, Ochsenbein A, Früh M, Cathomas R, Nackaerts K, Peters S, Mamot C, Zippelius A, Mordasini C, Caspar CB, Eckhardt K, Schmid RA, Aebersold DM, Gautschi O, Nagel W, Töpfer M, Krayenbuehl J, Ribi K, Cierni — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete macroscopic resection (part 1) | After surgery (15 weeks after trial registration) | ||
Primary | Loco-regional relapse-free survival (part 2) | From surgery until the first occurrence of loco-regional relapse | ||
Secondary | Response to neoadjuvant therapy (part 1) | Every 6 months in the follow-up until death for a maximum of 5 years | ||
Secondary | Adverse drug reaction to neoadjuvant therapy (part 1) | According to CTCAE | ||
Secondary | Operability (part 1) | Proportion of patients remaining operable after completing chemotherapy (9 weeks after trial registration) | ||
Secondary | Surgical complications (part 1) | Within 3 month after surgery | ||
Secondary | Reasons for non-randomization (part 1) | Reasons for non-randomization include macroscopic incomplete resection, patients' refusal or patient can not be subjected to RT within 10 weeks after surgery. | ||
Secondary | Relapse-free or progression-free survival (part 1) | From registration until progression/relapse (loco-regional or distant) or death | ||
Secondary | Adverse reaction to postoperative radiotherapy (part 2) | According to CTCAE | ||
Secondary | Late toxicity (part 2) | Late toxicities occurring later than 6 weeks after the last RT fraction | ||
Secondary | Feasibility of postoperative radiotherapy (part 2) | Proportion of patients receiving at least 90% of planned RT dose | ||
Secondary | Relapse-free survival (part 2) | From registration until progression/relapse (loco-regional or distant) or death | ||
Secondary | Psychological distress (quality of life) (part 2) | Until 22 weeks after treatment termination | ||
Secondary | Overall survival | From registration until death for all registered patients, and from randomization to death for all randomized patients. |
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