A phase II feasibility trial of induction chemotherapy followed by extrapleural pneumonectomy and postoperative radiotherapy in patients with malignantpleural mesothelioma.
- Conditions
- malignant pleural mesotheliomaMedDRA version: 7.1Level: SOCClassification code 10029104
- Registration Number
- EUCTR2004-004273-28-GB
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 52
? Age < 70 years
? WHO performance status 0-1 (see Appendix B)
? Patient should be considered fit enough to receive chemotherapy, to undergo a
pneumonectomy and receive postoperative radiotherapy. The responsible physician,
surgeon and radiation therapist should judge the required fitness prior to registration, taking into account the results of all the relevant (i.e. pulmonary, cardiac) examinations.
? Pathologically proven malignant pleural mesothelioma (all subtypes accepted)
? cT3N1M0 or less according to UICC TNM classification (see Appendix F, Ref. 6)
? No N2 or N3 lymph nodes involvement (pathologically confirmed), cervical
mediastinoscopy required
? No clinical invasion of mediastinal structures (heart, aorta, spine, esophagus, etc.)
? No widespread chest wall invasion, only focal chest wall lesions are acceptable
? No clinical or radiological evidence of ‘shrinking hemithorax’
? No prior chemotherapy for mesothelioma
? No prior radiotherapy of the lower neck, thorax, and upper abdomen
? No secondary primary malignancy except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma).
? Adequate hematological, hepatic and renal function
? White Blood Cell Count > 3,5 x 109/l
? Absolute Neutrophil Count (ANC) > 1,5 x 109/l
? Platelet count > 100 x 109/l
? Hemoglobin > 11 g/dl
? Bilirubin < 1.5 x upper normal limit
? ASAT/ALAT < 1.5 x upper normal limit
? Alkaline phosphatase < 1.5 x upper normal limit
? Creatinine clearance > 60 ml/min
? Acceptable (predicted) post-radiotherapy renal function, as indicated by semiquantitative isotope renography, with a relative contribution of the contralateral kidney of at least 40%
? No pre-existing sensory neurotoxicity > grade 1 according Common Terminology
Criteria for Adverse Events (CTCAE) v3.0 ( http://ctep.cancer.gov/reporting/ctc.html).
? No clinically significant third-space fluid (for example pleural effusions or ascites) that cannot be managed with thoracentesis or pleurodesis (according to institutional practice)
? No uncontrolled infection
? Patients of reproductive potential must agree to use a reliable method of birth control during protocol treatment and for 3 months following the end of protocol treatment. Women of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test.
? Absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
? Before patient registration in the trial, written informed consent must be obtained
and documented according to national and local regulatory requirements and the
local rules followed in the institution.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study the feasibility of 3 courses of induction chemotherapy, followed by extrapleural pneumonectomy and postoperative radiotherapy in patients with malignant pleural mesothelioma.;Secondary Objective: ;Primary end point(s): Success of treatment which is defined as a patient who received the full protocol treatment (with allowance for some dose adjustments detailed in the protocol), is still alive 90 days after end of the protocol treatment without progression nor G3-G4 toxicity.
- Secondary Outcome Measures
Name Time Method