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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
| Oslo University Hospital | OTHER |
| University Hospital of North Norway | OTHER |
| Sorlandet Hospital HF |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | 3D conformal thoracic radiotherapy at a total dose of 45 Gy in 30 fractions, 2 fractions per day, 5 days a week |
|
| B | Experimental | 3D conformal thoracic radiotherapy at a total dose of 60 Gy in 40 fractions, 2 fractions per day, 5 days a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 45 Gy in 30 fractions | Radiation | 3D conformal thoracic radiotherapy at a total dose of 45 Gy in 30 fractions, 2 fractions per day, 5 days a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory analyses of associations between characteristics and blood biomarkers - and outcomes of therapy | All patients will be included in these analyses. Blood will be collected, the study group will define which markers to analyze when all patients have been enrolled. | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bjørn H Grønberg, md phd | Norwegian University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet København | Copenhagen | Denmark | ||||
| Odense University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33662285 | Result | 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. | |
| 40258573 |
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| OTHER_GOV |
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| 60 Gy in 40 fractions | Radiation | 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. |
|
| 2 years |
| Local control | Proportion of all patients who experience disease recurrence within radiotherapy fields assessed by comparing dose plans and follow-up CT scans. | 2 years |
| 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). | 3 years |
| 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. | 2 years |
| 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. | 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 |
| Odense |
| Denmark |
| Ålesund sykehus | Ålesund | Norway |
| Haukeland Universitetssykehus | Bergen | Norway |
| Vestre Viken HF, Drammen Sykehus | Drammen | Norway |
| Førde Sentralsykehus | Førde | Norway |
| Sykehuset Innlandet Gjøvik | Gjøvik | Norway |
| Haugesund sykehus | Haugesund | Norway |
| Sykehuset Levanger | Levanger | Norway |
| Sykehuset Namsos | Namsos | Norway |
| Akershus Universitetssykehus | Oslo | Norway |
| Oslo Universitetssykehus, Radiumhospitalet | Oslo | Norway |
| Sykehuset Østfold (Kalnes/Sarpsborg) | Sarpsborg | Norway |
| Universitetssjukehuset i Stavanger | Stavanger | Norway |
| University Hospital of North Norway, Pulmonology Department | Tromsø | Norway |
| Cancer Clinic at St. Olavs Hospital | Trondheim | Norway |
| Gävle Sjukhus | Gävle | Sweden |
| Sahlgrenska Sjukehuset | Gothenburg | Sweden |
| Skånes universitetssjukhus | Lund | Sweden |
| Universitetssjukehuset i Ôrebro | Örebro | Sweden |
| Karolinska University Hospital | Stockholm | Sweden |
| Norrlands Universitetssjukehus | Umeå | Sweden |
| Derived |
| 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. |
| 39802818 | Derived | 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. |
| 36716960 | Derived | 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. |
| 35183991 | Derived | 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. |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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