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Two Schedules of Hyperfractionated Thoracic Radiotherapy in Limited Disease Small Cell Lung Cancer

Study acronym: THORA
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria shortened, about 13 words
    • Secondary endpoints: details revised at 4 of 5 entries
    • Site details revised at 1 of 22 sites
    • Publications: details revised at 5 of 5 entries
  2. Re-verified, no change to tracked fieldsv17
  3. Publications: details revised at 1 of 5 entriesv16
  4. Study completion date: Jul 29, 2023 to Dec 31, 2033v15
  5. 2 versions Re-verified since Aug 31, 2021, no change to tracked fieldsv13-v14
Show 11 earlier versionsHide 11 earlier versions
  1. Start date: Jan 2014 to Jul 8, 2014
    • Primary completion date: Jun 2020 to Jul 29, 2020
    • Study completion date: Jun 2023 to Jul 29, 2023
    v12
  2. Re-verified, no change to tracked fieldsv11
  3. Study sites: 4 to 22v10
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 154 to confirmed 177
    • Study completion date: Dec 2020 to Jun 2023
    • Site details revised at 4 of 4 sites
    v9
  5. Re-verified, no change to tracked fieldsv8
  6. Phase: Phase 2 to Not applicablev7
  7. 4 versions Re-verified since Jan 14, 2015, no change to tracked fieldsv3-v6
  8. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 4 of 4 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The majority of patients with limited disease small cell lung cancer (SCLC) experience recurrent disease despite receiving concurrent chemoradiotherapy. New agents and dose-escalation of chemotherapy have not provided a survival benefit. Local failure accounts for high proportion of recurrences. Improved thoracic radiotherapy (TRT) might increase local control and thus reduce the recurrence rate and prolong survival. Positron emission tomography (PET CT) is better for staging of SCLC than computer tomography (CT) and bone scan. More precise localization of tumors leads to more accurate definition of target volumes for TRT and reduce the radiation dose to normal tissue. A large proportion of patients relapse and die within one and two year after therapy. Few patients survive longer than three years. Thus, two-year survival is considered a clinically highly relevant measure of efficacy. The aim of this study is to compare two schedules of TRT with respect to local control, progression free survival, overall survival, toxicity and health-related quality of life. In addition patients who have the best outcomes and tolerate chemoradiotherapy will be characterized (e.g. clinical characteristics, blood biomarkers, body composition).
Trial Details
NCT Number NCT02041845
Lead Sponsor Norwegian University of Science and Technology
Collaborators: St. Olavs Hospital, Oslo University Hospital, University Hospital of North Norway, Sorlandet Hospital HF
Conditions
(from sponsor)		 Small Cell Lung Carcinoma
Related terms Small Cell Lung Carcinoma
Enrollment 177 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov