SYSTEMS 2: a randomised phase II trial of standard versus dose escalated radiotherapy in the treatment of pain in malignant pleural mesothelioma

Completed

• Conditions: Cancer; Malignant pleural mesothelioma; Malignant pleural mesothelioma (MPM)

• Registration Number: ISRCTN12698107
• Lead Sponsor: HS Greater Glasgow & Clyde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-05
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

1. Histological and/or MDT diagnosis of MPM
2. Performance status 0-2 (ECOG)
3. Predicted life expectancy of >12 weeks
4. CT scan within 8 weeks of radiotherapy
5. Worst Pain =4/10 (0-10 Numerical Rating Scale) after optimisation of analgesics
6. Ability to provide written informed consent prior to participating in the trial and any trial related procedures being performed
7. Willingness to comply with scheduled visits, treatment plans and laboratory tests and other study procedures
8. Patients must have a radiotherapy plan compatible with both the standard arm (20 Gy in 5 fractions) and treatment arm (30-36 Gy in 5-6 fractions)

Exclusion Criteria

1. Patients who have received anti-cancer therapy within the 4 weeks prior to study entry that is likely to alter pain at the index site during the duration of the study
2. Patients who are planned to have further anti-cancer therapy within 6 weeks post radiotherapy treatment
3. Psychotic disorders or cognitive impairment
4. Co-existing lung tumours at the time of study entry
5. Pregnant or breastfeeding
6. Patients of child-bearing potential, who are unwilling to use 2 effective methods of contraception

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establish whether dose escalated, hypo-fractionated radiotherapy (36 Gy in 6#) increases the proportion of MPM patients experiencing a clinically significant improvement in pain at 5 weeks compared with standard radiotherapy (20 Gy in 5#)

Secondary Outcome Measures

Name	Time	Method
Determine the relative effects of dose escalated and standard radiotherapy on:<br>1. Acute toxicity at weeks 5 and 9<br>2. Pain response at week 5 and 9 ( BPI)<br>3. Radiological response at week 9, measured by CT scan reported to modified RECIST <br>4. Overall survival<br>5. Quality of life at weeks 5 and 9 (EORTC QLQ-C30)