Overview

Combined CFRT and SABR in Stage II and III NSCLC With Peripheral Tumors Smaller Than 5 cm.

Status:
Completed
Trial end date:
2018-11-11
Target enrollment:
0
Participant gender:
All
Summary
A phase I trial is being conducted in patients with inoperable locally advanced NSCLC to treat with a combination of Conventional Fractionated Radiotherapy (CFRT) on the mediastinal lymph nodes and Stereotactic Ablative Radiotherapy (SABR)on the primary tumor with concurrent chemotherapy. It is hypothesized that this will lead to an increase of local control and overall survival
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Netherlands Cancer Institute
Treatments:
Cisplatin
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