Lung cancer
Conditions
Interventions
i. Patients included in this study will be subjected to the following
procedures:
Standard 18FDG-PET-CT-scan with intravenous contrast agent for radiotherapy
planning purposes prior to treatment
18F
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed stage IIIA/B NSCLC (excluding pleural effusion or mixed pathology) 2. Irresectable disease (as assessed by multidisciplinary team) or patient refusing surgery 3. Disease which can be encompassed within a radical radiotherapy treatment plan in keeping with standard practice at the participating center 4. Proposed treatment consists of radiotherapy alone, induction chemotherapy followed by radiotherapy, or concurrent chemoradiation 5. WHO performance status 0 or 1 6. Adequate respiratory function: FEV1 * 1.5 L and DLCO > 40%, predicted on baseline pulmonary function tests 7. Age * 18 years, no upper age limit 8. Estimated life expectancy of more than 6 months 9. Patient is available for follow-up 10. Written informed consent obtained
Exclusion criteria
Exclusion criteria: 1. Clinically diagnosed NSCLC 2. Previous or current malignant disease likely to interfere with the protocol treatment or comparisons 3. Prior thoracic radiotherapy 4. Prior lobectomy / pneumonectomy 5. Prior chemotherapy using gemcitabine or bleomycine 6. Superior sulcus tumors if the brachial plexus is within the high-dose volume 7. Medically unstable (e.g., ischaemic heart disease, esophageal disorders) 8. Pregnancy 9. Connective tissue disorders 10. Inability to comply with protocol or trial procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment toxicity in terms of acute or late grade 2-4 esophageal and pulmonary adverse events, or other grade 2-4 adverse events (RTOG Acute Radiation Morbidity Scoring Criteria and RTOG/ESTRO Late Radiation Morbidity Scoring Schema) | — |
Secondary
| Measure | Time frame |
|---|---|
| Local-regional failure Progression-free survival Overall survival Death during or within 30 days of discontinuation of radiation treatment Quality of life (EORTC questionnaire QLQ-C13 and QCQ-LC13, H.A.D.S. questionnaire) Predictive value of 18F-fluoroglucose (18FDG-)PET of the primary tumor and metastatic mediastinal lymph nodes performed at three time-points: before, during (2nd week) and (3 months) after treatment; findings on 18FDG-PET-CT scans performed during treatment will not alter this. For patients undergoing surgery after (chemo)radiation (in accordance with the local protocol): Rate of pathological complete responses of the primary tumor and rate of non-viable tumor cells in treated mediastinal lymph nodes Correlation of immunohistochemical findings with alterations of the 18FDG-PET signal | — |
Countries
Netherlands
Outcome results
None listed