Trial Information

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

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.