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Radiother Oncol. 2015 Aug;116(2):276-80. doi: 10.1016/j.radonc.2015.07.008. Epub 2015 Jul 29.

Phase I study of stereotactic body radiation therapy for peripheral T2N0M0 non-small cell lung cancer with PTV<100 cc using a continual reassessment method (JCOG0702).

Author information

1
Department of Radiation Medicine, Hokkaido University Graduate School of Medicine, Sapporo, Japan. Electronic address: ronimaru@pop.med.hokudai.ac.jp.
2
Department of Radiation Medicine, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
3
JCOG Data Center, Center for Research Administration and Support, National Cancer Center, Tokyo, Japan.
4
Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Japan.
5
Department of Radiology, Koshigaya Municipal Hospital, Japan.
6
Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
7
Department of Image-based Medicine, Institute of Biomedical Research and Innovation, Kobe, Japan.
8
Department of Clinical Radiology, Kyushu University Graduate School of Medicine, Fukuoka, Japan.
9
Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan.
10
Department of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan.
11
Department of Radiology, University of Yamanashi Graduate School of Medical Science, Chuo, Japan.

Abstract

PURPOSE:

To estimate the maximum tolerated dose (MTD) and to determine the recommended dose (RD) of stereotactic body radiation therapy (SBRT) for peripheral T2N0M0 non-small cell carcinoma (NSCLC) with target volume (PTV) < 100 cc.

MATERIALS AND METHODS:

The continual reassessment method (CRM) was used to determine the dose level that patients should be assigned to and to estimate the MTD. Dose limiting toxicity (DLT) was grade 3 radiation pneumonitis (RP) within 180 days after the start of SBRT, grade 2 RP was used as a surrogate DLT. The RD was equal to the MTD. The dose was prescribed at D95 of the PTV.

RESULTS:

Fifteen patients were accrued. Only 1 experienced grade 2 RP at 60 Gy in 4 fractions. It was difficult to fulfill the dose constraints at 60 Gy in 4 fractions, and the maximum dose level assigned by CRM was changed to 55 Gy in 4 fractions. The lower limit of 95% of the credible interval exceeded the adjacent level, and the RD was determined as 55 Gy in 4 fractions.

CONCLUSIONS:

The RD of SBRT for peripheral T2N0M0 NSCLC with PTV<100 cc was determined to be 55 Gy in 4 fractions.

KEYWORDS:

Continual reassessment method; Non-small cell lung cancer (NSCLC); Phase I study; SBRT; Stereotactic body radiotherapy

PMID:
26233591
DOI:
10.1016/j.radonc.2015.07.008
[Indexed for MEDLINE]

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