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Malignant MesotheliomaPhase 3NCT00075699

Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma

A Phase 3 study testing cisplatin, mitomycin C and vincristine sulfate in people with Malignant Mesothelioma, run by Medical Research Council at 3 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Active symptom control may decrease chest pain, breathlessness, sweating, and general discomfort in patients with malignant pleural mesothelioma. It is not yet known if active symptom control is more effective with or without chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Mesothelioma
What is being tested?
cisplatin, mitomycin C and vincristine sulfate
Type of treatment
Surgery or procedure
How many people
840 participants
Where
3 sitesUnited Kingdom
Study dates
Sep 2003to not given
Phase
Phase 3
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

DISEASE CHARACTERISTICS:

  • Histologically and immunohistochemically confirmed malignant pleural mesothelioma
  • Epithelial and other histological types are allowed
  • No more than 3 months since diagnosis
  • Symptomatic pleural effusion must have been treated and brought under control by drainage, pleurodesis, or pleurectomy
  • Prior surgical resection of mesothelioma allowed provided 2 CT scans at least 6 weeks apart show stable or progressive disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC > 3,000/mm^3
  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3

Hepatic

  • Not specified

Renal

  • Creatinine clearance > 50 mL/min

Pulmonary

  • See Disease Characteristics

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Considered medically fit to receive chemotherapy
  • No other disease or prior malignancy likely to interfere with protocol treatments or comparisons
  • No clinical evidence of infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for mesothelioma

Endocrine therapy

  • Not specified

Radiotherapy

  • Prior local radiotherapy to a wound site after exploratory thoracotomy allowed

Surgery

  • See Disease Characteristics
  • See Radiotherapy

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

  • Leeds General Infirmary at Leeds Teaching Hospital NHS Trust

    Leeds, England, LS1 3EX

  • Saint Bartholomew's Hospital

    London, England, EC1A 7BE

  • Royal Marsden NHS Foundation Trust - Surrey

    Sutton, England, SM2 5PT

Other trials in United Kingdom

About this study

Official title: A Randomized Controlled Trial of Active Symptom Control With or Without Chemotherapy in the Treatment of Patients With Malignant Pleural Mesothelioma

RATIONALE: Active symptom control may decrease chest pain, breathlessness, sweating, and general discomfort in patients with malignant pleural mesothelioma. It is not yet known if active symptom control is more effective with or without chemotherapy.

PURPOSE: This randomized phase III trial is studying active symptom control and chemotherapy to see how well they work compared to active symptom control alone in treating patients with malignant pleural mesothelioma.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the overall survival of patients with malignant pleural mesothelioma treated with active symptom control (ASC) alone vs ASC and mitomycin, vinblastine, and cisplatin vs ASC and vinorelbine.

Secondary

  • Compare the toxic effects of these regimens in these patients.
  • Compare symptom palliation (chest pain, breathlessness, malaise, and sweating attacks) in patients treated with these regimens.
  • Compare the performance status of patients treated with these regimens.
  • Compare analgesic usage in patients treated with these regimens.
  • Compare the tumor response and progression-free survival of patients treated with these regimens.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive active symptom control (ASC) through regular visits at a specialist clinic. ASC may include steroids, analgesics, appetite stimulants, bronchodilators, and/or palliative radiotherapy, when required.
  • Arm II: Patients receive ASC and chemotherapy comprising mitomycin IV, vincristine IV, and cisplatin IV on day 1. Chemotherapy repeats every 21 days for a total of 4 courses.
  • Arm III: Patients receive ASC and vinorelbine IV over 5 minutes weekly for 6 weeks. Vinorelbine repeats every 55 days for a total of 2 courses.

Quality of life is assessed at baseline, every 3 weeks for 21 weeks, and then every 8 weeks thereafter.

Patients are followed at 15, 18, and 21 weeks, and then every 8 weeks thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 840 patients (280 per treatment arm) will be accrued for this study within 4 years.

Being tested
cisplatin, mitomycin C, vincristine sulfate, vinorelbine tartrate, pain therapy
Keywords
epithelial mesothelioma, localized malignant mesothelioma, advanced malignant mesothelioma
Medical subject headings
Mesothelioma, Malignant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cisplatinDrug

  • mitomycin CDrug

  • vincristine sulfateDrug

  • vinorelbine tartrateDrug

  • pain therapyProcedure or surgery

  • psychosocial assessment and careProcedure or surgery

  • quality-of-life assessmentProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

Secondary outcomes (7)

  1. Palliation of chest pain, breathlessness, malaise (e.g., feeling weak, tiredness, anorexia), and sweating attacks

  2. Performance status as measured by WHO grade

  3. Analgesic usage

  4. Toxicity as measured by the NCIC CTC

  5. Quality of life as assessed by the European Organization for Research and Treatment of Cancer

  6. Tumor response as measured by the RECIST criteria

  7. Progression-free survival as measured by CT scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2004 (estimated)
  2. Study startSep 2003

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
840 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00075699
Sponsor's protocol ID
BTS-MRC-MS01
Other IDs
CDR0000347461, ISRCTN54469112, EU-20349
Status last verified
Jun 2008
First submitted
9 Jan 2004
Last updated
7 Aug 2013
Results posted
No

Publications

  • Muers MF, Rudd RM, O'Brien ME, Qian W, Hodson A, Parmar MK, Girling DJ; British Thoracic Society Mesothelioma Group. BTS randomised feasibility study of active symptom control with or without chemotherapy in malignant pleural mesothelioma: ISRCTN 54469112. Thorax. 2004 Feb;59(2):144-8. doi: 10.1136/thorax.2003.009290.

    PubMed 14760156

  • Qian W, Muers MF, Rudd RM, et al.: A feasibility study of active symptom control (ASC) with or without chemotherapy in malignant pleural mesothelioma. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2568, 639, 2003.

  • Muers MF, Stephens RJ, Fisher P, Darlison L, Higgs CM, Lowry E, Nicholson AG, O'Brien M, Peake M, Rudd R, Snee M, Steele J, Girling DJ, Nankivell M, Pugh C, Parmar MK; MS01 Trial Management Group. Active symptom control with or without chemotherapy in the treatment of patients with malignant pleural mesothelioma (MS01): a multicentre randomised trial. Lancet. 2008 May 17;371(9625):1685-94. doi: 10.1016/S0140-6736(08)60727-8.

    PubMed 18486741

  • Muers M, Fisher P, Snee M, et al.: A randomized phase III trial of active symptom control (ASC) with or without chemotherapy in the treatment of patients with malignant pleural mesothelioma: first results of the Medical Research Council (MRC) / British Thoracic Society (BTS) MS01 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA7525, 390s, 2007.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin, mitomycin C and vincristine sulfate in people with Malignant Mesothelioma, run by Medical Research Council at 3 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00075699, which also lists 4 linked publications.

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 Aug 2013; AzTrials last refreshed its copy on 1 Nov 2026.

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