NCT03632603 PAlliative RAdioTherapy to Lung Cancer A Randomized Multicentre Phase III Study
| NCT ID | NCT03632603 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Aarhus |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,184 participants |
| Start Date | 2018-11-22 |
| Primary Completion | 2025-08 |
Trial Parameters
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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.
Eligibility Criteria
Inclusion criteria: * 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 criteria: * 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.
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