NCT00075699

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
840

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2004

Completed
Last Updated

August 7, 2013

Status Verified

June 1, 2008

First QC Date

January 9, 2004

Last Update Submit

August 6, 2013

Conditions

Malignant Mesothelioma

Keywords

epithelial mesotheliomalocalized malignant mesotheliomaadvanced malignant mesothelioma

Outcome Measures

Primary Outcomes (1)

  • Overall survival

Secondary Outcomes (7)

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

  • Performance status as measured by WHO grade

  • Analgesic usage

  • Toxicity as measured by the NCIC CTC

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

  • +2 more secondary outcomes

Interventions

cisplatinDRUG
mitomycin CDRUG
vincristine sulfateDRUG
vinorelbine tartrateDRUG
pain therapyPROCEDURE
psychosocial assessment and carePROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Leeds General Infirmary at Leeds Teaching Hospital NHS Trust

Leeds, England, LS1 3EX, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 14760156BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 18486741RESULT

  • 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.

    RESULT

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

CisplatinMitomycinVincristineVinorelbineAnalgesiaPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsMitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolizidinesIndolizinesAnesthesia and AnalgesiaRehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Martin F. Muers, MD

    Leeds General Infirmary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 9, 2004

First Posted

January 13, 2004

Study Start

September 1, 2003

Last Updated

August 7, 2013

Record last verified: 2008-06

Locations

GB(3)