A phase II feasibility trial of induction chemotherapy followed by extrapleural pneumonectomy and postoperative radiotherapy in patients with malignant pleural mesothelioma.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004273-28-GB

Enrollment

Registered

2005-08-24

Start date

2005-11-15

Completion date

Unknown

Last updated

2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant pleural mesothelioma MedDRA version: 7.1 Level: SOC Classification code 10029104

Interventions

Trade Name: Alimta Product Name: Alimta Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: permetrexed CAS Number: 150399-23-8 Current Sponsor code: LY231514 Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Age 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 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Italy, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026