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

NCT02041845 · tracked via the Priya Life Science Sweden tracker

Sponsor

Norwegian University of Science and Technology

Phase

Not applicable

Started

2014-07-08

Last updated

2025-06-06

Condition(s) studied

Small Cell Lung Carcinoma

Investigational drug(s) / intervention(s)

45 Gy in 30 fractions60 Gy in 40 fractions

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.

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

survival — 2 years
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).

Trial sites (22)

Facility	City	Region
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02041845 on ClinicalTrials.gov ↗ ← All trials in Sweden