Malignant Pleural MesotheliomaNCT01343264
Trimodality Therapy for Malignant Pleural Mesothelioma
An observational study of Malignant Pleural Mesothelioma, run by HSK Wiesbaden at 1 site in Germany.
Trial summary
The role of surgical resection in the management of Malignant Pleural Mesothelioma (MPM) is still controversial. The selection criterion to perform either Extrapleural Pneumonectomy (EPP) or Pleurectomy/Decortication (P/D) is dependent not only on the cardio-pulmonary status of the patient, tumor stage and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Mesothelioma
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2002to Dec 2012
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with malignant pleural mesothelioma prsentint at the Deparment of Thoracic Surgery, HSK Wiesbaden
Who may be able to join
- Histologically confirmed diagnosis of MPM (all subtypes)
- Clinical T1-3, N0-2, M0 disease.
- No prior treatment for MPM.
- Adequate renal and liver function
- Adequate cardio-pulmonary reserves
Who cannot join
- Patients with unresectable disease
- Patients with an active infection that require systemic treatments
- Patients with a concurrent active malignancy.
- Patients with serious medical illness.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Dr. Horst Schmidt Klinik, Department of Thoracic Surgery
Wiesbaden
Joachim Schirren, MD, PhD, +49 611 433132, joachim.schirren@hsk-wiesbaden.de
Joachim Schirren, MD, PhD
About this study
Official title: Trimodality Therapy for Malignant Pleural Mesothelioma: Radical Pleurectomy, Followed by Adjuvant Chemotherapy With Cisplatin/Pemetrexed and Radiotherapy
The role of surgical resection in the management of Malignant Pleural Mesothelioma (MPM) is still controversial. The selection criterion to perform either Extrapleural Pneumonectomy (EPP) or Pleurectomy/Decortication (P/D) is dependent not only on the cardio-pulmonary status of the patient, tumor stage and intraoperative findings but also on surgeons' decision and philosophy. There are no established guidelines. Radical Pleurectomy (RP) competes against EPP as surgical therapy modality. Both surgical approaches are cytoreductive treatment options. The aim is to remove all gross disease and to achieve macroscopic complete resection.
Originally P/D was a palliative option for controlling pleural effusion. But lung-sparing surgery for MPM seems to be an alternative to patients unsuitable or unwilling to undergo EPP in a multimodality therapy concept. Most studies evaluating multimodality therapies for MPM are based on retrospective analyses and their interpretation is difficult because of inhomogeneous patient groups studied.
The aim of our study was to analyze the feasibility and results of RP as surgical therapy modality in a standardized trimodality therapy concept.
- Conditions
- Malignant Pleural Mesothelioma
- Keywords
- Radical Pleurectomy, Pleurectomy/decortication, Cisplatin, Pemetrexed, Radiation
- Medical subject headings
- Mesothelioma, Malignant
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the overall 5-year survival rate.
Measured: 5-years
Secondary outcomes (3)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Morbidity
Measured: 3 months
Number of Participants with treatment related deaths as a Measure of Safety and Tolerability
Mortality
Measured: 3 months
Recurrence
Occurence of tumor recurrence
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startNov 2002
- Primary completionDec 2012 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HSK Wiesbaden
- Sponsor type
- University, hospital or other
- Investigators
- Joachim Schirren, MD, PhD, Principal investigator, HSK Wiesbaden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343264
- Sponsor's protocol ID
- RP2002-01
- Status last verified
- Apr 2011
- First submitted
- 5 Apr 2011
- Last updated
- 28 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trimodality Therapy for Malignant Pleural Mesothelioma: Radical Pleurectomy, Followed by Adjuvant Chemotherapy With Cisplatin/Pemetrexed and Radiotherapy
- ClinicalTrials.gov ID
- NCT01343264
- Acronym / sponsor ID
- RP2002-01
- Conditions
- Malignant Pleural Mesothelioma
- Keywords
- Radical Pleurectomy, Pleurectomy/decortication, Cisplatin, Pemetrexed, Radiation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- HSK WiesbadenUniversity, hospital or other
- Study start
- Nov 2002
- Primary completion
- Dec 2012 (estimated)
- First posted
- 28 Apr 2011 (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.
The role of surgical resection in the management of Malignant Pleural Mesothelioma (MPM) is still controversial. The selection criterion to perform either Extrapleural Pneumonectomy (EPP) or Pleurectomy/Decortication (P/D) is dependent not only on the cardio-pulmonary status of the patient, tumor stage and intraoperative findings but also on surgeons' decision and philosophy. There are no established guidelines. Radical Pleurectomy (RP) competes against EPP as surgical therapy modality. Both surgical approaches are cytoreductive treatment options. The aim is to remove all gross disease and to achieve macroscopic complete resection.
Originally P/D was a palliative option for controlling pleural effusion. But lung-sparing surgery for MPM seems to be an alternative to patients unsuitable or unwilling to undergo EPP in a multimodality therapy concept. Most studies evaluating multimodality therapies for MPM are based on retrospective analyses and their interpretation is difficult because of inhomogeneous patient groups studied.
The aim of our study was to analyze the feasibility and results of RP as surgical therapy modality in a standardized trimodality therapy concept.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with malignant pleural mesothelioma prsentint at the Deparment of Thoracic Surgery, HSK Wiesbaden
Key inclusion criteria (5 listed)
- Histologically confirmed diagnosis of MPM (all subtypes)
- Clinical T1-3, N0-2, M0 disease.
- No prior treatment for MPM.
- Adequate renal and liver function
- Adequate cardio-pulmonary reserves
Key exclusion criteria (4 listed)
- Patients with unresectable disease
- Patients with an active infection that require systemic treatments
- Patients with a concurrent active malignancy.
- Patients with serious medical illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the overall 5-year survival rate.
Time frame: 5-years
3 secondary outcomes
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 3 months
Number of Participants with treatment related deaths as a Measure of Safety and Tolerability
Time frame: 3 months
Recurrence
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2011.
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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.
Dr. Horst Schmidt Klinik, Department of Thoracic Surgery
Wiesbaden, Germany
Joachim Schirren, MD, PhD principal investigator
HSK Wiesbaden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Pleural Mesothelioma, run by HSK Wiesbaden at 1 site in Germany.
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 5 inclusion and 4 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 28 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the overall 5-year survival rate. (time frame: 5-years). 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 28 Apr 2011; AzTrials last refreshed its copy on 31 Oct 2026.