Optimisation of Radiotherapy-Planning in Patients With Inoperable Locally Advanced Non-Small-Cell Lung Cancer by FDG-PET
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- time to local progression
- Last Updated
- 9 years ago
Overview
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
Investigators
Prof. Dr. Ursula Nestle
Prof. Dr. Ursula Nestle, Universitätsklinikum Freiburg
Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN
Eligibility Criteria
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
Outcomes
Primary Outcomes
time to local progression
Time Frame: actuarial
Time from randomization to first evidence of local progression or last follow up
Secondary Outcomes
- Overall survival(actuarial)
- normal tissue toxicity(actuarial)
- in and out field progression(actuarial)