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Int J Radiat Oncol Biol Phys. 2015 Dec 1;93(5):989-96. doi: 10.1016/j.ijrobp.2015.07.2278. Epub 2015 Nov 11.

Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 Non-Small Cell Lung Cancer: Japan Clinical Oncology Group Study JCOG0403.

Author information

1
Department of Radiation Oncology, Hiroshima University, Hiroshima, Japan. Electronic address: nagat@hiroshima-u.ac.jp.
2
Department of Radiation Oncology and Image-Applied Therapy, Kyoto University, Kyoto, Japan.
3
Japan Clinical Oncology Group Data Center, Center for Research Administration and Support, National Cancer Center, Tokyo, Japan.
4
Department of Radiology, University of Yamanashi, Chuo, Japan.
5
Department of Image-Based Medicine, Institute of Biomedical Research and Innovation, Kobe, Japan.
6
Department of Radiation Oncology, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan.
7
Department of Clinical Radiology, Kyushu University, Fukuoka, Japan.
8
Department of Radiology, Hokkaido University, Sapporo, Japan.
9
Department of Radiation Oncology, The Cancer Institute Hospital, Tokyo, Japan.
10
Department of Radiation Oncology, Keio University, Tokyo, Japan.
11
Department of Radiology, Nihon University Itabashi Hospital, Tokyo, Japan.
12
Department of Radiology, The University of Tokyo Hospital, Tokyo, Japan.
13
Department of Radiology, Sapporo Medical University, Sapporo, Japan.
14
Department of Radiation Oncology, Tohoku University, Sendai, Japan.
15
Department of Radiology and Radiation Oncology, Kitasato University, Sagamihara, Japan.
16
Department of Radiation Oncology, Tokyo Women's Medical University, Tokyo, Japan.
17
Department of Radiology, Koshigaya Municipal Hospital, Koshigaya, Japan.

Abstract

PURPOSE:

To evaluate, in Japan Clinical Oncology Group study 0403, the safety and efficacy of stereotactic body radiation therapy (SBRT) in patients with T1N0M0 non-small cell lung cancer (NSCLC).

METHODS AND MATERIALS:

Eligibility criteria included histologically or cytologically proven NSCLC, clinical T1N0M0. Prescribed dose was 48 Gy at the isocenter in 4 fractions. The primary endpoint was the percent (%) 3-year overall survival. The threshold % 3-year survival to be rejected was set at 35% for inoperable patients, whereas the expected % 3-year survival was 80% for operable patients.

RESULTS:

Between July 2004 and November 2008, 169 patients from 15 institutions were registered. One hundred inoperable and 64 operable patients (total 164) were eligible. Patients' characteristics were 122 male, 47 female; median age 78 years (range, 50-91 years); adenocarcinomas, 90; squamous cell carcinomas, 61; others, 18. Of the 100 inoperable patients, the % 3-year OS was 59.9% (95% confidence interval 49.6%-68.8%). Grade 3 and 4 toxicities were observed in 10 and 2 patients, respectively. No grade 5 toxicity was observed. Of the 64 operable patients, the % 3-year OS was 76.5% (95% confidence interval 64.0%-85.1%). Grade 3 toxicities were observed in 5 patients. No grade 4 and 5 toxicities were observed.

CONCLUSIONS:

Stereotactic body radiation therapy for stage I NSCLC is effective, with low incidences of severe toxicity. This treatment can be considered a standard treatment for inoperable stage I NSCLC. This treatment is promising as an alternative to surgery for operable stage I NSCLC.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00238875.

Comment in

PMID:
26581137
DOI:
10.1016/j.ijrobp.2015.07.2278
[Indexed for MEDLINE]

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