None listed
Conditions
Interventions
Patients were randomized, without stratification, either to the multiple fractionation scheme of 10 x 3 Gy, 4 - 5 times a week, or the hypofractionation scheme of 2 x 8 Gy, given at day 1 and day 8.
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. The diagnosis NSCLC had to be cytologically or histologically confirmed; 2. Tumor stage was IIIA or IIIB in combination with performance status 3 – 4 and/or a weight loss of more than 5% in 3 months or >10% in 6 months prior to diagnosis; 3. Also patients with stage IV NSCLC, not suitable for chemotherapeutic treatment, were included; 4. Patients had to have a minimum total symptom score of 8, indicating a score >1 for at least one of the following complaints caused by the tumor itself: loss of appetite, dyspnea, chest pain, coughing, hemoptysis, hoarseness and/or dysphagia; 5. Furthermore, the patient should be physically and mentally fit enough to participate in this study.
Exclusion criteria
Exclusion criteria: Patients having a Superior Vena Cava Syndrome (SVCS) at presentation, prior radiotherapy to the chest and/or other malignant diseases in the past, or concurrent chemotherapy were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Palliation of thoracic symptoms measured over 52 weeks after randomization. The data collection schedule for follow-up is presented in table 2. A maximum of 33 questionnaires per patient would be sent in case follow-up could be completed. The first questionnaire was given before randomization, the last questionnaire in the 52nd week after randomization. Data about effectiveness of the treatment and QOL were based on the Rotterdam Symptom Checklist (10). Seven symptoms could be scored each on a four point validated scale from 1 (no complaints) to 4 (severe complaints) (10). The baseline total symptom score had to be 8 indicating that the patient had at least one tumor related complaint. The maximum total symptom score could be 28 indicating the patient had all seven complaints in the worst degree. After response the lowest total symptom score could be 7, having no complaints at all. Palliation was defined as a average total score below the baseline score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity, Quality of Life (QOL), and survival. Quality of life was measured using the EuroQol classification system (EQ-5D), consisting of five questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (11). In addition, information about acute toxicity as nausea, vomiting, and radiation esophagitis induced dysphagia was collected, based on the NCIC CTG Expanded Common Toxicity Criteria (12). Patients were also asked to provide information about costs. Together with quality of life data, these data will be published separately in a cost-utility analysis. Follow up after 52 weeks was continued by the datamanager, who made 3-monthly inquiries after survival of the patient. | — |
Contacts
Public ContactG.W.P.M. Kramer
Arnhems Radiotherapeutisch Instituut, Wagnerlaan 47
Outcome results
None listed