RecruitingPhase 3NCT03632603

PAlliative RAdioTherapy to Lung Cancer A Randomized Multicentre Phase III Study

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


Sponsor

University of Aarhus

Enrollment

1,184 participants

Start Date

Nov 22, 2018

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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.

Exclusion Criteria2

  • 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.

Interventions

RADIATIONNo intervention

No intervention during study period.


Locations(1)

Aarhus University Hospital

Aarhus, Denmark

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NCT03632603


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