NCT02041845Active, not recruiting
Two Schedules of Hyperfractionated Thoracic Radiotherapy in Limited Disease Small Cell Lung Cancer
A Randomized Phase II Study Comparing Two Schedules of Hyperfractionated Thoracic Radiotherapy in Limited Disease Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 177 (actual)
- First submitted
- 14 Jan 2014
- Start date
- 8 Jul 2014
- Primary completion date
- 29 Jul 2020
- Lead sponsor
- Norwegian University of Science and Technology
- Diseases
- Lung cancer
- NCT number
- NCT02041845
What you commit to
- Study type: Interventional
- Participants enrolled: 177
- From 8 Jul 2014 to the primary completion date, 29 Jul 2020
- 22 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- prior systemic therapy for small-cell lung cancer
- Previous radiotherapy to the thorax
- 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
Other illness
- malignant cells in pericardial or pleural fluid (at least one sample should be analysed if pleural fluid is present
- 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
Other
- pregnancy, lactation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet København Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
| Ålesund sykehus Coordinator of this site? Confirm its status | Ålesund | Norway | Unknown status |
| Haukeland Universitetssykehus Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
| Vestre Viken HF, Drammen Sykehus Coordinator of this site? Confirm its status | Drammen | Norway | Unknown status |
| Førde Sentralsykehus Coordinator of this site? Confirm its status | Førde | Norway | Unknown status |
| Sykehuset Innlandet Gjøvik Coordinator of this site? Confirm its status | Gjøvik | Norway | Unknown status |
| Haugesund sykehus Coordinator of this site? Confirm its status | Haugesund | Norway | Unknown status |
| Sykehuset Levanger Coordinator of this site? Confirm its status | Levanger | Norway | Unknown status |
| Sykehuset Namsos Coordinator of this site? Confirm its status | Namsos | Norway | Unknown status |
| Akershus Universitetssykehus Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Oslo Universitetssykehus, Radiumhospitalet Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Sykehuset Østfold (Kalnes/Sarpsborg) Coordinator of this site? Confirm its status | Sarpsborg | Norway | Unknown status |
| Universitetssjukehuset i Stavanger Coordinator of this site? Confirm its status | Stavanger | Norway | Unknown status |
| University Hospital of North Norway, Pulmonology Department Coordinator of this site? Confirm its status | Tromsø | Norway | Unknown status |
| Cancer Clinic at St. Olavs Hospital Coordinator of this site? Confirm its status | Trondheim | Norway | Unknown status |
| Gävle sjukhus Coordinator of this site? Confirm its status | Gävle | Sweden | Unknown status |
| Sahlgrenska Sjukehuset Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Skanes universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
| Universitetssjukehuset i Ôrebro Coordinator of this site? Confirm its status | Örebro | Sweden | Unknown status |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Norrlands Universitetssjukehus Coordinator of this site? Confirm its status | Umeå | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.