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Mesothelioma and Radical Surgery Trial


N/A
18 Years
N/A
Open (Enrolling)
Both
Malignant Mesothelioma

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Trial Information

Mesothelioma and Radical Surgery Trial


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Clare Peckitt

Investigator Role:

Study Chair

Investigator Affiliation:

Institute of Cancer Research, United Kingdom

Authority:

United States: Federal Government

Study ID:

CDR0000448615

NCT ID:

NCT00253409

Start Date:

May 2005

Completion Date:

Related Keywords:

  • Malignant Mesothelioma
  • localized malignant mesothelioma
  • Mesothelioma

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