AzTrials
AzTrials

Small Cell Lung CarcinomaTHORANCT02041845

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

A study testing 45 Gy in 30 fractions and 60 Gy in 40 fractions in people with Small Cell Lung Carcinoma, run by Norwegian University of Science and Technology at 22 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Carcinoma
What is being tested?
45 Gy in 30 fractions and 60 Gy in 40 fractions
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
177 participants
Where
22 sitesin 3 countries
Study dates
8 Jul 2014to 31 Dec 2033
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed small-cell lung cancer (SCLC)
  • Limited disease (stage II-III)
  • Stage I if ineligible for surgery
  • Eastern Cooperative Oncology Group (ECOG) Performance 0-2
  • Measureable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
  • Adequate organ function defined as: (a) Serum serum alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN); (b) Total serum bilirubin ≤ 1.5 x ULN; (c) Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; (d) Platelets ≥ 100 x 109/L; (e) Creatinine < 100 µmol/L and calculated creatinine-clearance > 50 ml/min. If calculated creatinine-clearance is < 50 ml/min, an ethylene diamine tetra-acetic acid (EDTA) clearance should be performed.
Show all 9Show fewer
  • Pulmonary function: Forced Expiratory Volume in One Second (FEV1) > 1 l or 30 % of predicted value and diffusing capacity of the lungs for carbon monoxide (DLCO) > 30 % of predicted value
  • All fertile patients should use safe contraception
  • Written informed consent

Who cannot join

  • prior systemic therapy for small-cell lung cancer
  • Previous radiotherapy to the thorax
  • malignant cells in pericardial or pleural fluid (at least one sample should be analysed if pleural fluid is present
  • serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study treatment
  • conditions - medical, social, psychological - which could prevent adequate information and follow-up
  • clinically active cancer other than SCLC. Hormonal therapy for prostate cancer or breast cancer and basocellular carcinoma of the skin is allowed
  • pregnancy, lactation

Trial locations and contacts

22 sites in 3 countries.

22 sites in 3 countries

Norway14 sites

  • Ålesund sykehus

    Ålesund

  • Haukeland Universitetssykehus

    Bergen

  • Vestre Viken HF, Drammen Sykehus

    Drammen

  • Førde Sentralsykehus

    Førde

  • Sykehuset Innlandet Gjøvik

    Gjøvik

  • Haugesund sykehus

    Haugesund

  • Sykehuset Levanger

    Levanger

  • Sykehuset Namsos

    Namsos

  • Akershus Universitetssykehus

    Oslo

  • Oslo Universitetssykehus, Radiumhospitalet

    Oslo

  • Sykehuset Østfold (Kalnes/Sarpsborg)

    Sarpsborg

  • Universitetssjukehuset i Stavanger

    Stavanger

  • University Hospital of North Norway, Pulmonology Department

    Tromsø

  • Cancer Clinic at St. Olavs Hospital

    Trondheim

Other trials in Norway

Sweden6 sites

  • Gävle Sjukhus

    Gävle

  • Sahlgrenska Sjukehuset

    Gothenburg

  • Skånes universitetssjukhus

    Lund

  • Universitetssjukehuset i Ôrebro

    Örebro

  • Karolinska University Hospital

    Stockholm

  • Norrlands Universitetssjukehus

    Umeå

Other trials in Sweden

Denmark2 sites

  • Rigshospitalet København

    Copenhagen

  • Odense University Hospital

    Odense

Other trials in Denmark

About this study

Official title: A Randomized Phase II Study Comparing Two Schedules of Hyperfractionated Thoracic Radiotherapy in Limited Disease Small Cell Lung Cancer

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).

Being tested
45 Gy in 30 fractions, 60 Gy in 40 fractions
Keywords
Radiotherapy, Radiotherapy dosage, Dose fractionation, Radiotherapy, image-guided, Thorax
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 45 Gy in 30 fractionsRadiation

    3D conformal thoracic radiotherapy at a total dose of 45 Gy in 30 fractions, 2 fractions per day, 5 days a week

  • 60 Gy in 40 fractionsRadiation

    3D conformal thoracic radiotherapy at a total dose of 60 Gy in 40 fractions, 2 fractions per day, 5 days a week. If doses to organs at risk exceed normal tissue tolerance, the dose may be lowered to a minimum of 54 Gy.

Study groups in NCT02041845
Study groupRoleWhat they receive
AActive comparator3D conformal thoracic radiotherapy at a total dose of 45 Gy in 30 fractions, 2 fractions per day, 5 days a week
Receives: Radiation: 45 Gy in 30 fractions
BExperimental3D conformal thoracic radiotherapy at a total dose of 60 Gy in 40 fractions, 2 fractions per day, 5 days a week
Receives: Radiation: 60 Gy in 40 fractions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. survival

    measured for all patients from the date of the first day of the first course of chemotherapy until the date of death from any cause (or last contact/observation if lost to follow-up - or the follow-up is completed before all patients die).

    Measured: 2 years

Secondary outcomes (5)

  1. progression free survival (PFS)

    measured for all patients from the date of the first day of the first course of PE to the first date of objective progression (according to RECIST 1.1) of disease or of death from any cause. For each patient who has not died or has non-progression at the cut-off date for the analysis, PFS will be censored at the date of the patient's last tumor assessment prior to the cut-off date. Statistical survival analyses will be done with Kaplan Meier. Log rank test will be used for comparing groups.

    Measured: 2 years

  2. Local control

    Proportion of all patients who experience disease recurrence within radiotherapy fields assessed by comparing dose plans and follow-up CT scans.

    Measured: 2 years

  3. overall survival

    measured for all patients from the date of the first day of the first course of chemotherapy until the date of death from any cause (or last contact/observation if lost to follow-up - or the follow-up is completed before all patients die).

    Measured: 3 years

  4. toxicity

    assessed for all patients receiving at least one course of chemotherapy from reported blood values and adverse event. Classified and graded according to CTCAE 4.0. Compared using Pearson's Chi-square and Fischer's exact tests.

    Measured: 2 years

  5. health related quality of life (HRQoL)

    assessed from completed questionnaires. Patients will report HRQoL on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 and the lung cancer specific module LC13. The QLQ-C30 measures fundamental aspects of HRQoL and symptoms commonly reported by cancer patients in general, the LC13 measures symptoms commonly associated with lung cancer and its treatment.

    All HRQoL scores will be transformed to a scale from 0 to 100 according to the EORTC scoring manual. A difference in mean scores of >10 is considered clinically relevant. For group comparisons of baseline scores during and after chemotherapy, and changes in scores from baseline, the Mann-Whitney test will be used. Primary HRQoL-endpoints are dysphagia and dyspnea.

    Measured: From baseline, before and after radiotherapy and then at follow-up every 3 months until 24 months after start of chemotherapy. Then every 6 months until 5 year after start of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2014 (estimated)
  2. Study start8 Jul 2014
  3. Primary completion29 Jul 2020
  4. Study completion31 Dec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02041845
Sponsor's protocol ID
2013/2163
Acronym
THORA
Status last verified
Oct 2026
First submitted
14 Jan 2014
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No

Publications

  • Gronberg BH, Killingberg KT, Flotten O, Brustugun OT, Hornslien K, Madebo T, Langer SW, Schytte T, Nyman J, Risum S, Tsakonas G, Engleson J, Halvorsen TO. High-dose versus standard-dose twice-daily thoracic radiotherapy for patients with limited stage small-cell lung cancer: an open-label, randomised, phase 2 trial. Lancet Oncol. 2021 Mar;22(3):321-331. doi: 10.1016/S1470-2045(20)30742-7.

    PubMed 33662285

  • Gronberg BH, Killingberg KT, Flotten O, Bjaanaes MM, Brustugun OT, Madebo T, Langer SW, Risumlund SL, Schytte T, Helbekkmo N, Neumann K, Yksnoy O, Engleson J, Fluge S, Naustdal T, Giske LE, Nyman J, Tsakonas G, Halvorsen TO. High-Dose Versus Standard-Dose Twice-Daily Thoracic Radiotherapy in Limited-Stage SCLC: Final Survival Data, Long-Term Toxicity, and Relapse Patterns in a Randomized, Open-Label, Phase II Trial. J Thorac Oncol. 2025 Aug;20(8):1108-1119. doi: 10.1016/j.jtho.2025.04.007. Epub 2025 Apr 19.

    PubMed 40258573

  • Taranova E, Aanerud M, Halvorsen TO, Killingberg KT, Slaaen M, Gronberg BH. Associations Between Patient-Reported Nutritional Status, Toxicity, and Survival in Limited-Stage SCLC. JTO Clin Res Rep. 2024 Nov 12;6(1):100764. doi: 10.1016/j.jtocrr.2024.100764. eCollection 2025 Jan.

    PubMed 39802818

  • Killingberg KT, Gronberg BH, Slaaen M, Kirkevold O, Halvorsen TO. Treatment Outcomes of Older Participants in a Randomized Trial Comparing Two Schedules of Twice-Daily Thoracic Radiotherapy in Limited-Stage SCLC. J Thorac Oncol. 2023 Jun;18(6):803-812. doi: 10.1016/j.jtho.2023.01.012. Epub 2023 Jan 27.

    PubMed 36716960

  • Killingberg KT, Halvorsen TO, Flotten O, Brustugun OT, Langer SW, Nyman J, Hornslien K, Madebo T, Schytte T, Risum S, Tsakonas G, Engleson J, Gronberg BH. Patient-reported health-related quality of life from a randomized phase II trial comparing standard-dose with high-dose twice daily thoracic radiotherapy in limited stage small-cell lung cancer. Lung Cancer. 2022 Apr;166:49-57. doi: 10.1016/j.lungcan.2022.02.002. Epub 2022 Feb 8.

    PubMed 35183991

Questions about this trial

What is this clinical trial studying?

A study testing 45 Gy in 30 fractions and 60 Gy in 40 fractions in people with Small Cell Lung Carcinoma, run by Norwegian University of Science and Technology at 22 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Norway, Sweden, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02041845, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in