Format

Send to

Choose Destination
Radiother Oncol. 2017 May;123(2):276-281. doi: 10.1016/j.radonc.2017.03.017. Epub 2017 Apr 11.

A randomized phase II trial of concurrent chemoradiation with two doses of radiotherapy, 60Gy and 66Gy, concomitant with a fixed dose of oral vinorelbine in locally advanced NSCLC.

Author information

1
Department of Oncology, Odense University Hospital, Denmark. Electronic address: olfred.hansen@rsyd.dk.
2
Oncology, Aarhus University Hospital, Denmark.
3
Oncology, Vejle Hospital, Denmark.
4
Oncology, Aalborg University Hospital, Denmark.
5
Oncology, Herlev University Hospital, Denmark.
6
Laboratory of Radiation Physics, Odense University Hospital, Denmark.
7
Medical Physics, Aarhus University Hospital, Denmark.
8
Department of Oncology, Odense University Hospital, Denmark.

Abstract

INTRODUCTION:

In order to test the best performing radiation dose with a convenient chemotherapy schedule of an oral formulation of radio-sensitizing vinorelbine in inoperable locally advanced non-small cell lung cancer (NSCLC), we performed a randomized phase II trial based on a "pick the winner" design.

METHODS:

After 2 cycles of neoadjuvant chemotherapy, 117 patients with NSCLC stage IIB-IIIB in performance status 0-1 were randomized to radiotherapy 60Gy/30 fractions or 66Gy/33 fractions concurrent with a fixed dose of oral vinorelbine 50mg administered 3 times weekly. The primary endpoint was local progression free interval. A scheduled FDG-PET-CT-scan was performed 9months after randomization. The study was registered at ClinicalTrials.gov (NCT 00887783).

RESULTS:

Both arms were well tolerated. The local progression free interval at 9months was 54% in the 60Gy arm and 59% in the 66Gy arm (log rank test p=0.55). There was no statistically significant difference in overall survival. The median survival was 23.3 and 23.7months in the 60 and 66Gy arm, respectively. No significant difference in toxicity was observed.

CONCLUSION:

Both 60 and 66Gy administered concomitant with oral vinorelbine showed similar local control and overall survival, and was well tolerated. The pick the winner design choose 66Gy as the winning arm.

KEYWORDS:

Chemoradiotherapy; Dose–effect; Locally advanced disease; Non-small cell lung carcinoma; Oral vinorelbine; Radical radiotherapy

PMID:
28410809
DOI:
10.1016/j.radonc.2017.03.017
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center