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

Norwegian University of Science and Technology

Status

Active, not recruiting

Conditions

Small Cell Lung Carcinoma

Treatments

Radiation: 60 Gy in 40 fractions

Radiation: 45 Gy in 30 fractions

Study type

Interventional

Funder types

Other

Identifiers

NCT02041845

2013/2163

Details and patient eligibility

About

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).

Enrollment

177 patients

Sex

All

Ages

18+ years old

Volunteers

No 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