Radiotherapy Planning Based on Positron Emission Tomography With Fluoro-deoxyglucose For Advanced NSCLC
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Procedure: restriction of radiotherapy to FDG-PET positive areas only
- Registration Number
- NCT00697333
- Lead Sponsor
- Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B restriction of radiotherapy to FDG-PET positive areas only Irradiation of all tumor manifestations detectable by positron emission tomography using fluoro-deoxy-glucose including the whole affected lymph node stations by 60 - 74 Gy/2Gy
- Primary Outcome Measures
Name Time Method time to local progression actuarial Time from randomization to first evidence of local progression or last follow up
- Secondary Outcome Measures
Name Time Method 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
in and out field progression actuarial Time from randomization to progression or last follow up
Trial Locations
- Locations (1)
Universitätsklinikum Freiburg
🇩🇪Freiburg i. Br., Baden-Württemberg, Germany