C34.1
Conditions
Interventions
Group 1: Preoperative particle therapy (39GyE in 13 fractions) of the primary tumor and adjective lymphatic drainage in combination with a cisplatin/vinorelbine chemotherapy followed by surgical resec
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • 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)
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and feasibility based on the incidence of NCI-CTC-AE °3/4 side effects and/or discontinuance due to any reason | — |
Secondary
| Measure | Time frame |
|---|---|
| Regression rate, metabolic tumor regression, morphologic tumor regression, quality of life (EORTC QLQ-C30, LC13) after 5-7, 13-15 weeks and 6 month | — |
Countries
Germany
Outcome results
None listed