Combined CFRT and SABR in Stage II and III NSCLC With Peripheral Tumors Smaller Than 5 cm.
Conditions
Inoperable Locally Advanced Non Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: SABR Type: Radiation
Name: Cisplatin Type: Drug
Overall Status
Recruiting
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
Detailed 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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
The Netherlands Cancer Institute
Amsterdam, Netherlands
Status: Recruiting
Contact: Heike Peulen, MD - +31 20 512 2135 - h.peulen@nki.nl
Start Date
February 2013
Completion Date
February 2016
Sponsors
The Netherlands Cancer Institute
Source
The Netherlands Cancer Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page