Non-small Cell Lung Cancer
Conditions
Keywords
NSCLC, FDG-PET, Radiotherapy, planning, target volumes
Brief summary
Simultaneous radio-chemotherapy in advanced non-small cell lung cancer. The study focusses on a randomised comparison of conventional radiotherapy planning with irradiation of macroscopic tumor and lymph nodes together with prophylactic target volumes vs. irradiation only of FDG-positive lesions. Primary endpoint is the local disease control in the chest.
Detailed description
Simultaneous radio-chemotherapy in advanced non-small cell lung cancer. The study focusses on a randomised comparison of conventional radiotherapy planning with irradiation of macroscopic tumor and lymph nodes together with prophylactic target volumes vs. irradiation only of FDG-positive lesions. Primary endpoint is the local disease control in the chest
Interventions
Restriction of target volumes to areas positive in positron emission tomography using fluoro-deoxy-glucose
Sponsors
Study design
Eligibility
Inclusion criteria
* histologically proved NSCLC * UICC-stage I-III, no resection planned * complete staging \< 6 wks before treatment including cranial CT * ECOG \<3, Karnofsky-Index \>60% * age \> 18 \< * FEV1 \> 1,0 l or \>35% * RT-planning according to protocol feasible * chemotherapy feasible * written informed consent
Exclusion criteria
* neuroendocrine tumors, plain broncho-alveolar-cell ca. * distant metastases, supraclavicular lymph node metastases * malignant pleural effusion * resection of actual tumor performed * inclusion in other study protocol * chemotherapy due to actual tumor before FDG-PET * induction-chemotherapy * acute vena cava superior syndrome * second malignancy other than basalioma * pregnancy, lactation * heart insufficiency NYHA III/IV * pneumoconiosis with active inflammatory changes of mediastinal lymph nodes * acute broncho-pulmonary infection at time of PET-examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to local progression | actuarial | Time from randomization to first evidence of local progression or last follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| in and out field progression | actuarial | Time from randomization to progression or last follow up |
| Overall survival | actuarial | Time from randomization to death or last follow up |
| normal tissue toxicity | actuarial | Time from randomization to death or last follow up |
Countries
Germany