Combined CFRT and SABR in Stage II and III NSCLC With Peripheral Tumors Smaller Than 5 cm. (N12HYB)

Netherlands Cancer Institute (NKI)

Status and phase

Completed

Phase 1

Conditions

Inoperable Locally Advanced Non Small Cell Lung Cancer

Treatments

Radiation: SABR

Drug: Cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01933568

N12HYB

Details and patient eligibility

About

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

Full description

In locally advanced NSCLC local control has been poor, but with SABR remarkable high local control rates with low toxicity have been reported. Currently stage III and inoperable II NSCLC patients have been treated with IMRT and concurrent chemotherapy at out institute. In this study we will explore the combination of SABR and CFRT with concurrent chemotherapy

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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