PARAT PAlliative RAdioTherapy to Lung Cancer A Randomized Multicentre Phase III Study

Who is this study for? Patients with lung cancer in performance status 0-2
What treatments are being studied? No intervention
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The aim of this study is to examine if a shorter palliative radiotherapy fractionation scheme of 20 Gy / 4 F can reduce the early oesophageal toxicity compared to 30 Gy / 10 F in patients with lung cancer in performance status (PS) 0-2. Secondary aims are to examine the effect on lung cancer symptoms, quality of life (QoL) and survival. Furthermore, the investigators aim at standardizing the quality of palliative thoracic radiotherapy in all Danish centres at the highest technical level.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically or cytologically confirmed NSCLC or SCLC.

• Stages III-IV not candidates for curative treatment

• Age ≥18 years.

• Performance status: 0-2

• Signed informed consent.

• Fertile women must have a negative pregnancy test. Fertile men and women must use effective contraception. Fertile women included in the study must use the pill, spiral, depot injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch for the duration of study treatment and one month thereafter.

Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Contact Information
Primary
Marianne Marquard Knap, PhD, MD
mariknap@rm.dk
0045 22985576
Backup
Lone Hoffmann, PhD,
lone.hoffmann@aarhus.rm.dk
0045 29939779
Time Frame
Start Date: 2018-11-22
Estimated Completion Date: 2025-08
Participants
Target number of participants: 1184
Treatments
Experimental: Radiotherapy 20 Gy / 4 F
Radiotherapy 20 Gy / 4 F
Active_comparator: Radiotherapy 30 Gy/ 10 F
Radiotherapy 30 Gy/ 10 F
Related Therapeutic Areas
Sponsors
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov