Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT01933568
Eligibility Criteria:
Inclusion Criteria:
* Cytological or histological proven NSCLC stage III or inoperable stage II, cT1-2a-3N1-3M0 with peripheral tumors \< 5 cm (chest wall infiltration is no exclusion criteria if the tumor diameter is \< 5 cm).
* Weight loss \< 10% in the last three months
* WHO-performance status ≤ 2
* Patients that receive concurrent chemoradiotherapy, with the exception of adriamycin and gemcitabine
* FEV1 and DLCO \> 40 % of the age-adjusted normal value
* Minimum required laboratory data bone marrow reserve and hepatic- and renal function
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Before patient registration, written informed consent must be given according to GCP and national regulations
Exclusion criteria:
* Patients with central tumors \< 2 cm of the proximal bronchial tree (Figure 2) or tumors immediately adjacent to mediastinal or pericardial pleura.
* Patients that receive sequential chemoradiotherapy or radiotherapy only.
* Patients with grade 3 dyspnea at baseline (according to CTCAE version 4.03)
* Patients with Pancoast tumors
* Prior radiotherapy treatment to the thorax
* Any contraindications to the administration of thoracic radiotherapy
* Pregnant women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01933568
Study Brief:
Protocol Section:
NCT01933568