Brief Title
Pleurectomy/ Decortication (P/D) Preceded or Followed by Chemotherapy in Patients With Early Stage MPM
Official Title
EORTC Randomized Phase II Study of Pleurectomy/ Decortication (P/D) Preceded or Followed by Chemotherapy in Patients With Early Stage Malignant Pleural Mesothelioma
Brief Summary
This is a multicenter, randomized, 1:1, non-comparative phase II trial. Patients with early
stage MPM will be randomized between Arm A: immediate P/D followed by three cycles of
chemotherapy (pemetrexed 500mg/m2 and cisplatin 75 mg/m2, both drugs given on day 1, every
three weeks) Arm B: three cycles of chemotherapy (same regimen) followed by P/D, for
non-progressing patients
Detailed Description
This is an academic led, multicenter, randomized, 1:1, non-comparative phase II trial.
Patients with early stage MPM will be randomized between
- Arm A - immediate surgery: immediate P/D followed by three cycles of chemotherapy
(pemetrexed 500mg/m2 and cisplatin 75 mg/m2, both drugs given on day 1, every three
weeks) for non-progressing patients
- Arm B - delayed surgery: three cycles of chemotherapy (same regimen) followed by P/D,
for non-progressing patients.
A maximum of four weeks (±2 weeks) will be allowed between the baseline tumor assessment and
the start of treatment (surgery or chemotherapy). Randomization should be done as soon as
possible after baseline tumor assessment.
The primary objective of the study is to investigate the feasibility of immediate P/D
followed by cisplatin/pemetrexed chemotherapy or deferred P/D after cisplatin/pemetrexed
chemotherapy in patients with early stage MPM.
The results of this study will allow the LCG to take one of the arms further to a comparative
study with either no surgery or EPP as control arm. The choice of the comparator will depend
on the result of a parallel ongoing randomized study in the UK, comparing P/D with no surgery
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Rate of success to complete the full treatment
Secondary Outcome
Loco-regional failure free survival
Condition
Malignant Pleural Mesothelioma
Intervention
pleurectomy/decortication
Study Arms / Comparison Groups
Immediate pleurectomy/decortication
Description: immediate P/D followed by three cycles of pemetrexed 500mg/m2 IV and cisplatin 75 mg/m2 IV, both drugs given on day 1, every three weeks for non-progressing patients
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
64
Start Date
October 2016
Completion Date
April 2020
Primary Completion Date
September 2019
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18 years or older, with pathologically proven malignant pleural
mesothelioma. All histological subtypes are accepted.
- 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 invasion of mediastinal structures (heart, aorta, spine, esophagus, etc.) and
no widespread chest wall invasion (T4) are acceptable. Focal chest wall lesions are
acceptable.
- No prior treatment of any kind for mesothelioma is allowed, especially prophylactic
track irradiation after diagnostic procedures.
- WHO performance status 0-1
- Fit to receive chemotherapy and undergo a pleurectomy/ decortication with optional
removal of hemidiaphragm and pericardium.
- 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.
- No pre-existing peripheral sensory or motor neuropathy > grade I according to CTCAE
v4.0
- 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.
- Adequate organ function Women of child bearing potential 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.
Before patient registration written informed consent must be given according to ICH/GCP,
and national/local regulations.
Exclusion Criteria
• 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).
significant cardiovascular morbidity (assessed by cardiologist) precluding surgery
- 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.
- History of receiving any investigational treatment within 28 days of randomization.
- History of intolerance to pemetrexed and/or cisplatin.
- Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol.
Gender
All
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Jan Van Meerbeeck, Pr., +32 2 774 1611, [email protected]
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT02436733
Organization ID
EORTC-1205
Responsible Party
Sponsor
Study Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor
Jan Van Meerbeeck, Pr., Principal Investigator, UZ Antwerpen, Belgium
Verification Date
July 2018