Ion Therapy within the Trimodal Management of Superior Sulcus Tumors
- Conditions
- C34.1Upper lobe, bronchus or lung
- Registration Number
- DRKS00006323
- Lead Sponsor
- niversitätsklinikum Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 17
•histological confirmed superior sulcus tumor (NSCLC)
•maximal stage N1 in a FDG-PET-CT (not older than 6 weeks)
•age between 18 and 75 years
•Karnofsky Performance Score >/=70
•Written informed consent (must be available before enrolment in the trial)
•refusal of the patients to take part in the study
•medical contraindications against one of the parts in the trimodal concept
•stage N2/3 disease in FDG-PET-CT
•stage IV disease
•previous radiotherapy of the thoracic region
•Participation in another clinical study or observation period of competing trials, respectively
•no capacity to consent
•active medical devices, for which no approval for ion-therapy exists (i.e. cardiac pacemaker, defibrillator, …)
•decompensated diseases of the lungs, cardio-pulmonal system, metabolism, hematopoetic system, coagulation system or renal function
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and feasibility based on the incidence of NCI-CTC-AE °3/4 side effects and/or discontinuance due to any reason
- Secondary Outcome Measures
Name Time Method Regression rate, metabolic tumor regression, morphologic tumor regression, quality of life (EORTC QLQ-C30, LC13) after 5-7, 13-15 weeks and 6 month