EORTC randomized phase II study of pleurectomy/decortication preceded or followed by chemotherapy in patients with early stage malignant pleural mesothelioma.

Completed

• Conditions: 'Mesothelioma' and 'pleural tumor'; 10027412; 10035597; 10038737

• Registration Number: NL-OMON53100
• Lead Sponsor: European Organisation for Research in Treatment of Cancer (EORTC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

1. Patients are aged 18 years or older, with pathologically proven malignant
pleural mesothelioma (MPM). All histological subtypes are accepted.
2. Stage cT1-3, N0-2, M0 according to UICC TNM classification. FDG-PET-CT scan
showing absence of M1, N3, supraclavicular and coeliac node involvement is
required. No clinical or radiological invasion of mediastinal structures
(heart, aorta, spine, esophagus, etc.) and no widespread chest wall invasion
(T4) are acceptable. Focal chest wall lesions are acceptable.
3. No prior treatment of any kind for mesothelioma is allowed, especially
prophylactic track irradiations after diagnostic procedures.
4. WHO performance status 0-1.
5. Fit to receive chemotherapy and undergo a P/D with optional removal of
hemidiaphragm and pericardium. The responsible surgeon and chest physician
should judge the required fitness prior to registration, taking into account
the results of all the relevant (i.e. pulmonary, cardiac) examinations.
6. No history of other malignancy within the last three years, except for
carcinoma in situ of the cervix or basal cell or spinocellular carcinoma of the
skin.
7. No pre-existing peripheral sensory or motor neuropathy > grade I according
to CTCAE v4.0.
8. No clinically significant pleural effusion that cannot be managed with
thoracentesis or pleurodesis (according to institutional practice). If
pleurodesis is considered, it should be done before randomization.
9. No significant cardiovascular morbidity (assessed by cardiologist)
precluding surgery.
10. Adequate organ function, evidenced by the following laboratory results
within two weeks (+/- 3 days) prior to randomization with a buffer range from
the normal values of +/- 5% for hematology and +/- 10% for biochemistry [with
the EXCEPTION of Glomerular Filtration Rate] are acceptable):
*absolute neutrophil count >1500/l;
*Platelet count >100,000/l;
*Hemoglobin >11.0g/dL or 7 mmol/L;
*Total bilirubin <=1.5 upper limit of normal (ULN);
*SGOT (AST), SGPT (ALT), and alkaline phosphatase <=2.5×ULN;
*Glomerular Filtration Rate (GFR)>= 50 ml/min according to Cockcroft and Gault
Formula.
11. No current severe, uncontrolled systemic disease (e.g., clinically
significant cardiovascular, pulmonary, or metabolic disease, wound healing
disorders; ulcers; or bone fractures, known infection with HIV, active
hepatitis B and/or hepatitis C virus).
12. No major surgical procedure or significant traumatic injury within 28 days
prior to randomization or anticipation of the need for major surgery (other
than P/D) during the course of study treatment.
13. No history of receiving any investigational treatment within 28 days of
randomization.
14. No known hypersensitivity to pemetrexed or cisplatin or carboplatin or
their components.
15. Women of child bearing potential (WOCBP) must have a negative serum (or
urine) pregnancy test within 3 days prior to the start of chemotherapy/surgery.
Patients of childbearing/reproductive potential should use adequate birth
control measures, as defined by the investigator, during the study treatment
period and for at least three months after the last study treatment. A highly
effective method of birth control is defined as those which result in low
failure rate (i.e. less than 1% per year) when used consistently and correctly.

Exclusion Criteria

Mentioned earlier (inclusion criteria).

Study & Design

• Study Type: Interventional
• Study Design: Not specified