PAlliative RAdioTherapy to Lung Cancer A Randomized Multicentre Phase III Study
PARAT
PARAT PAlliative RAdioTherapy to Lung Cancer A Randomized Multicentre Phase III Study
1 other identifier
interventional
1,184
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 lung-cancer
Started Nov 2018
Typical duration for phase_3 lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedStudy Start
First participant enrolled
November 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedMay 8, 2024
May 1, 2024
6.7 years
August 13, 2018
May 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Early oesophagitis
Early oesophagitis measured by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 0-5, (higher values represent worse outcome)
2 weeks after completion of radiotherapy
Secondary Outcomes (4)
Symptom releaf
2 weeks, 3 weeks, 8-10 weeks and 6 months after completion of radiotherapy
Overall survival
3 years after radiotherapy
Quality of life (QoL)
2 weeks, 3 weeks, 8-10 weeks and 6 months post treatment
Disease response
8-10 weeks after completion of radiotherapy
Study Arms (2)
Radiotherapy 20 Gy / 4 F
EXPERIMENTALRadiotherapy 20 Gy / 4 F
Radiotherapy 30 Gy/ 10 F
ACTIVE COMPARATORRadiotherapy 30 Gy/ 10 F
Interventions
No intervention during study period.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Prior radiotherapy to the thorax that prohibits the delivery of 30 Gy/10 F with respect to OAR dose constraints.
- Patients not able to understand the written or spoken information.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aarhus University Hospital
Aarhus, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2018
First Posted
August 15, 2018
Study Start
November 22, 2018
Primary Completion
August 1, 2025
Study Completion
August 1, 2025
Last Updated
May 8, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share