Mesothelioma and Radical Surgery 2 (MARS2)
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| ClinicalTrials.gov Identifier: NCT02040272 |
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Recruitment Status : Unknown
Verified October 2019 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : January 20, 2014
Last Update Posted : October 30, 2019
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Mesothelioma is a cancer of the thin membrane that lines the chest and abdomen. Around 2500 people in the UK are diagnosed with mesothelioma each year and the median survival is approximately 8.5 months. Exposure to asbestos is the most common cause although the cancer does not usually become apparent until 40-60 years after exposure. Anti-cancer drugs (chemotherapy) are usually given to help treat mesothelioma and sometimes lung-sparing surgery (pleurectomy decortication) is undertaken. However, it is not known if this surgery, in addition to chemotherapy, can increase survival and improve the quality of life for patients. The aim of the MARS2 study is to compare surgery - (extended) pleurectomy decortication - with no surgery with respect to overall survival, cost-effectiveness and quality of life. Patients will be followed up by phone at regular intervals for 2 years. Patients will be asked to complete and return a Quality of Life Questionnaire at these time points.
MARS 2 also includes an optional 'Information study', where consenting patients may be interviewed or have their consultations audio-recorded. The aim of the Information study is to explore how a patient makes a decision to take part in research or not, with the overall aim of improving recruitment to clinical trials.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mesothelioma | Procedure: (Extended) pleurectomy decortication | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 328 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Mesothelioma and Radical Surgery 2: a Multicentre Randomised Trial Comparing (Extended) Pleurectomy Decortication Versus no (Extended) Pleurectomy Decortication for Patients With Malignant Pleural Mesothelioma (Mars 2). |
| Study Start Date : | May 2015 |
| Estimated Primary Completion Date : | September 2020 |
| Estimated Study Completion Date : | September 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Surgery
(Extended) pleurectomy decortication
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Procedure: (Extended) pleurectomy decortication |
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No Intervention: no surgery
no surgery
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- Survival [ Time Frame: 24 months ]The time from randomisation to death will be measured and date of death will be collected on purposely designed case report forms.
- Progression free survival to two years [ Time Frame: 24 months ]
- Serious adverse health events to two years after randomisation [ Time Frame: 24 months ]
- Health Related Quality of Life: EORTC QLQ-C30 (questionnaire) to two years [ Time Frame: 24 months ]
- 3 types of scales. Functioning scales which include physical functioning, role functioning, emotional function, cognitive functioning and social functioning. Symptom scales which include fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties. An overall global health status/QoL
- All scales range between 0 and 100.
- For functioning scales, a high score indicates a high level of functioning. Similarly, a high global health status/QoL score indicates a high quality of life. For symptom scales, a high score indicates a high level of symptoms.
- Resource and health service use to two years and during initial surgical admission for surgical arm [ Time Frame: 24 months and during initial surgical admission for surgical arm ]
- Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years [ Time Frame: 24 Months ]
- subscales: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. These range from 1-5.
- subscales mobility, self-care, usual activities, pain/discomfort, anxiety/depression are combined to calculate an overall index score which ranges from -0.59 to 1.
- A higher score indicates better quality of life
- Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years [ Time Frame: 24 months ]
- VAS (visual analogue scale) score. Ranges from 0 to 100.
- A higher score indicates better quality of life
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- 16 years of age or over
- Tissue (cytology or histology) confirmed epithelioid, sarcomatoid or biphasic mesothelioma
- Disease confined to one hemi-thorax based on CT assessment
- Disease deemed surgically resectable
- Fit for surgery
- Capacity to provide written informed consent to participate in the trial
Exclusion criteria:
- Severe shortness of breath (this is defined as an Eastern Cooperative Oncology Group (ECOG) status ≥ 2, or if lung function tests are performed: pre-operative forced expiratory volume after one second (FEV1) or transfer factor of the lung for carbon monoxide (TLco) less than 20%)
- Serious concomitant disorder that would compromise participant safety during surgery (e.g. evidence of end organ failure)
- Severe heart failure (this is defined as NYHA III or IV or if an echocardiogram is performed an ejection fraction less than 30%)
- End stage kidney failure requiring dialysis
- Liver failure (e.g. encephalopathy and/or coagulation abnormalities)
- Prisoner
- Patient lacks capacity to consent
- Existing co-enrolment in another interventional clinical trial that aims to improve survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02040272
| Contact: Eric Lim | e.lim@rbht.nhs.uk | ||
| Contact: Study Mailbox | Mars2-trial@bristol.ac.uk |
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| Principal Investigator: | Eric Lim | Royal Brompton & Harefield NHS Foundation Trust |
| Responsible Party: | Royal Brompton & Harefield NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT02040272 |
| Other Study ID Numbers: |
MARS2 |
| First Posted: | January 20, 2014 Key Record Dates |
| Last Update Posted: | October 30, 2019 |
| Last Verified: | October 2019 |
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Mesothelioma Mesothelioma, Malignant Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Pleural Neoplasms Lung Diseases Respiratory Tract Diseases |