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Two Schedules of Hyperfractionated Thoracic Radiotherapy in Limited Disease Small Cell Lung Cancer
Sponsor: Norwegian University of Science and Technology
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. 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).
Official title: A Randomized Phase II Study Comparing Two Schedules of Hyperfractionated Thoracic Radiotherapy in Limited Disease Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
177
Start Date
2014-07-08
Completion Date
2033-12-31
Last Updated
2025-06-06
Healthy Volunteers
No
Conditions
Interventions
45 Gy in 30 fractions
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 fractions
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.
Locations (22)
Rigshospitalet København
Copenhagen, Denmark
Odense University Hospital
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