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Malignant MesotheliomaNCT00253409

Combination Chemotherapy With or Without Surgery and Radiation Therapy in Treating Patients With Mesothelioma That Can Be Removed By Surgery

A study testing chemotherapy, adjuvant therapy and conventional surgery in people with Malignant Mesothelioma, run by Institute of Cancer Research, United Kingdom at 17 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. 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?
chemotherapy, adjuvant therapy and conventional surgery
Type of treatment
Surgery or procedure
How many people
670 participants
Where
17 sitesUnited Kingdom
Study dates
May 2005to Jun 2011
Phase
Interventional
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 immuno-histochemically confirmed malignant mesothelioma
  • Resectable disease (T1-3, N0-1, M0) with no distant metastases
  • Eligible to undergo extra-pleural pneumonectomy based on British Thoracic Society guidelines

PATIENT CHARACTERISTICS:

Performance status

  • WHO 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Normal renal function

Cardiovascular

  • Ejection fraction ≥ 40%

Pulmonary

  • Predicted post-operative FEV_1 ≥ 40%
  • Predicted post-operative DLCO ≥ 40%
  • No significant pulmonary hypertension

Other

  • No physical or personal condition that would preclude ability to undergo chemotherapy or post-operative radiotherapy
  • No physical or personal condition that would preclude ability to comply with follow-up requirements

PRIOR CONCURRENT THERAPY:

  • Not specified

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United Kingdom17 sites

  • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

    Birmingham, England, B15 2TH

  • Birmingham Heartlands Hospital

    Birmingham, England, B9 5SS

  • Bristol Royal Infirmary

    Bristol, England, BS2 8HW

  • Queen's Hospital

    Burton-on-Trent, England, DE13 0RB

  • Addenbrooke's Hospital

    Cambridge, England, CB2 2QQ

  • Papworth Hospital

    Cambridge, England, CB3 8RE

  • Ipswich Hospital

    Ipswich, England, IP4 5PD

  • Cookridge Hospital

    Leeds, England, LS16 6QB

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • Glenfield Hospital

    Leicester, England, LE3 9QP

  • St. Thomas' Hospital

    London, England, SE1 9RT

  • Royal Marsden - London

    London, England, SW3 6JJ

  • Nottingham City Hospital NHS Trust

    Nottingham, England, NG5 1PB

  • Berkshire Cancer Centre at Royal Berkshire Hospital

    Reading, England, RG1 5AN

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

  • Institute of Cancer Research - Sutton

    Sutton, England, SM2 5NG

  • Royal Marsden - Surrey

    Sutton, England, SM2 5PT

Other trials in United Kingdom

About this study

Official title: Mesothelioma and Radical Surgery Trial

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without surgery and radiation therapy in treating mesothelioma.

PURPOSE: This randomized clinical trial is studying combination chemotherapy, surgery, and radiation therapy to see how well they work compared to combination chemotherapy alone in treating patients with mesothelioma that can be removed by surgery.

Read the detailed description

OBJECTIVES:

  • Compare the feasibility of neoadjuvant combination chemotherapy with vs without surgery and adjuvant radiotherapy in patients with resectable malignant mesothelioma.
  • Compare the overall survival of patients treated with these regimens.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a multicenter, pilot study followed by a randomized, controlled study.

Patients undergo 3 courses of a platinum-based (cisplatin or carboplatin) combination chemotherapy regimen to be determined by the treatment center. Upon completion of combination chemotherapy, patients are randomized to 1 of 2 treatment arms provided tumor is resectable and there is no disease progression.

  • Arm I: Patients undergo extra-pleural pneumonectomy followed by post-operative radiotherapy.
  • Arm II: Patients undergo follow-up only. Patients may receive additional standard therapy according to their treatment center.

Quality of life is assessed at baseline, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

After completion of study treatment, patients are followed periodically for 2 years and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 50-670 patients will be accrued for this study.

Being tested
chemotherapy, adjuvant therapy, conventional surgery, neoadjuvant therapy, radiation therapy
Keywords
localized 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.

Timeline

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

  1. First posted15 Nov 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionJun 2011 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Enrolment
670 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00253409
Sponsor's protocol ID
CDR0000448615
Other IDs
ICR-CTSU-MARS, EU-20532
Status last verified
Jul 2009
First submitted
11 Nov 2005
Last updated
14 Jul 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing chemotherapy, adjuvant therapy and conventional surgery in people with Malignant Mesothelioma, run by Institute of Cancer Research, United Kingdom at 17 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: status not confirmed, as of the sponsor's last update on 14 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00253409.

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 14 Jul 2009.

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