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NCT02041845
NA

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

Sponsor: Norwegian University of Science and Technology

View on ClinicalTrials.gov

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

Interventions

RADIATION

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

RADIATION

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