Malignant Pleural MesotheliomaPhase 2NCT02436733
Pleurectomy/ Decortication (P/D) Preceded or Followed by Chemotherapy in Patients With Early Stage MPM
A Phase 2 study testing pleurectomy/decortication and Pemetrexed/Cisplatin in people with Malignant Pleural Mesothelioma, run by European Organisation for Research and Treatment of Cancer - EORTC at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Malignant Pleural Mesothelioma
- What is being tested?
- pleurectomy/decortication and Pemetrexed/Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 20 Sep 2016to Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Netherlands2 sites
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Amsterdam
Erasmus MC Hospital
Rotterdam
About this study
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
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
Read the 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
- Conditions
- Malignant Pleural Mesothelioma
- Being tested
- pleurectomy/decortication, Pemetrexed/Cisplatin
- Keywords
- pleural mesothelioma, phase II, randomized, surgery, chemotherapy, feasibility
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pleurectomy/decorticationProcedure or surgery
Also called P/D
Lung sparing procedures consist of the resection of the pleura without removing the lung
Pemetrexed/CisplatinDrug
Also called CisPem
On day 1 of each cycle, pemetrexed 500 mg/m2 should be administered as IV infusion followed by cisplatin 75 mg/m2 as IV.
| Study group | Role | What they receive |
|---|---|---|
| Immediate pleurectomy/decortication | Experimental | 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 Receives: Procedure: pleurectomy/decortication; Drug: Pemetrexed/Cisplatin |
| Delayed pleurectomy/decortication | Active comparator | three cycles of pemetrexed 500mg/m2 IV and cisplatin 75 mg/m2 IV, both drugs given on day 1, every three weeks followed by P/D, for non-progressing patients. Receives: Procedure: pleurectomy/decortication; Drug: Pemetrexed/Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of success to complete the full treatment
A patient is considered to be a "treatment success" if he/she meets all of the following criteria:
- Patient has received the full protocol treatment, defined as 3 cycles of pemetrexed and cisplatin (allowing for the dose adjustments described in section 5.3), preceded/followed by pleurectomy/decortication (P/D) (as described in section 5.3).
- Patient alive and has no evidence of progression/relapse at week 20 (±2 weeks) after the first day of starting protocol treatment (either chemotherapy or P/D).
- Patient has no persisting grade 3-4 treatment side-effects (CTCAE V 4.0) at week 20 (±2 weeks) after the first day of starting protocol treatment (either chemotherapy or P/D)
Measured: 20weeks
Secondary outcomes (3)
Loco-regional failure free survival
Loco-Regional Failure Free Survival (LRFFS) is defined as the time interval between the date of randomization and the date of relapse in hemithorax or mediastinum or death, whichever comes first
Measured: 6 months
Overall survival
the time interval between the date of randomization and the date of death of any cause
Measured: 15 months
Treatment side-effects
Treatment side-effects will be assessed for all patients and graded per CTCAE category upon occurrence of the event. The investigator will assess whether those events are surgery or/and drug related (no reasonable possibility, reasonable possibility) and this assessment will be recorded in the database for all adverse events. Surgical side effects during the perioperative period will be scored according to the Clavien-Dindo Classification of Surgical Complications as an exploratory approach.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study start20 Sep 2016
- Primary completionJul 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jan Van Meerbeeck, Pr., Principal investigator, UZ Antwerpen, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436733
- Sponsor's protocol ID
- EORTC-1205
- Status last verified
- Nov 2022
- First submitted
- 21 Apr 2015
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02436733
- Acronym / sponsor ID
- EORTC-1205
- Conditions
- Malignant Pleural Mesothelioma
- Keywords
- pleural mesothelioma, phase II, randomized, surgery, chemotherapy, feasibility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 7 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate pleurectomy/decortication | Experimental | Procedure: pleurectomy/decortication, Drug: Pemetrexed/Cisplatinimmediate 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 |
| Delayed pleurectomy/decortication | Active comparator | Procedure: pleurectomy/decortication, Drug: Pemetrexed/Cisplatinthree cycles of pemetrexed 500mg/m2 IV and cisplatin 75 mg/m2 IV, both drugs given on day 1, every three weeks followed by P/D, for non-progressing patients. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pleurectomy/decorticationAlso: P/DLung sparing procedures consist of the resection of the pleura without removing the lung | Procedure or surgery | Delayed pleurectomy/decortication, Immediate pleurectomy/decortication |
| Pemetrexed/CisplatinAlso: CisPemOn day 1 of each cycle, pemetrexed 500 mg/m2 should be administered as IV infusion followed by cisplatin 75 mg/m2 as IV. | Drug | Delayed pleurectomy/decortication, Immediate pleurectomy/decortication |
Primary outcome
Rate of success to complete the full treatment
Time frame: 20weeks
A patient is considered to be a "treatment success" if he/she meets all of the following criteria: 1. Patient has received the full protocol treatment, defined as 3 cycles of pemetrexed and cisplatin (allowing for the dose adjustments described in section 5.3), preceded/followed by pleurectomy/decortication (P/D) (as described in section 5.3). 2. Patient alive and has no evidence of progression/relapse at week 20 (±2 weeks) after the first day of starting protocol treatment (either chemotherapy or P/D). 3. Patient has no persisting grade 3-4 treatment side-effects (CTCAE V 4.0) at week 20 (±2 weeks) after the first day of starting protocol treatment (either chemotherapy or P/D)
3 secondary outcomes
Loco-regional failure free survival
Time frame: 6 months
Overall survival
Time frame: 15 months
Treatment side-effects
Time frame: 36 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Van Meerbeeck, Pr. principal investigator
UZ Antwerpen, Belgium
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pleurectomy/decortication and Pemetrexed/Cisplatin in people with Malignant Pleural Mesothelioma, run by European Organisation for Research and Treatment of Cancer - EORTC at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of success to complete the full treatment (time frame: 20weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.