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Ann Oncol. 2018 Apr 1;29(4):992-997. doi: 10.1093/annonc/mdy036.

Results of a multi-institutional, randomized, non-inferiority, phase III trial of accelerated fractionation versus standard fractionation in radiation therapy for T1-2N0M0 glottic cancer: Japan Clinical Oncology Group Study (JCOG0701).

Author information

1
Department of Radiation Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
2
Department of Radiation Oncology, Showa University, Tokyo, Japan.
3
Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
4
Department of Radiation Oncology, Juntendo University, Tokyo, Japan.
5
Department of Radiation Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.
6
Department of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
7
Department of Radiation Oncology, Saitama Cancer Center, Saitama, Japan.
8
Department of Radiation Oncology, Niigata Cancer Center Hospital, Niigata, Japan.
9
Department of Radiation Oncology, Osaka International Cancer Institute, Osaka, Japan.
10
Department of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan.
11
Department of Radiation Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
12
Department of Radiology, Sapporo Medical University, Sapporo, Japan.
13
Department of Radiation Oncology, The Cancer Institute Hospital of JFCR, Tokyo, Japan.
14
Department of Radiology, Tokyo University, Tokyo, Japan.
15
Department of Radiation Oncology, Hiroshima University, Hiroshima, Japan.
16
Department of Radiation Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
17
Department of Radiology, Chiba University Hospital, Chiba, Japan.
18
Department of Radiation Oncology, Shikoku Cancer Center, Matsuyama, Japan.
19
Department of Radiology, Tokyo Medical Center, Tokyo, Japan.
20
Department of Radiation Oncology and Image-Applied Therapy, Kyoto University Hospital, Kyoto, Japan.

Abstract

Background:

We assessed the non-inferiority of accelerated fractionation (AF) (2.4 Gy/fraction) compared with standard fractionation (SF) (2 Gy/fraction) regarding progression-free survival (PFS) in patients with T1-2N0M0 glottic cancer (GC).

Patients and methods:

In this multi-institutional, randomized, phase III trial, patients were enrolled from 32 Japanese institutions. Key inclusion criteria were GC T1-2N0M0, age 20-80, Eastern Cooperative Oncology Group performance status of 0-1, and adequate organ function. Patients were randomly assigned to receive either SF of 66-70 Gy (33-35 fractions), or AF of 60-64.8 Gy (25-27 fractions). The primary end point was the proportion of 3-year PFS. The planned sample size was 360 with a non-inferiority margin of 5%.

Results:

Between 2007 and 2013, 370 patients were randomized (184/186 to SF/AF). Three-year PFS was 79.9% (95% confidence interval [CI] 73.4-85.4) for SF and 81.7% (95% CI 75.4-87.0) for AF (difference 1.8%, 91% CI-5.1% to 8.8%; one-sided P = 0.047 > 0.045). The cumulative incidences of local failure at 3 years for SF/AF were 15.9%/10.3%. No significant difference was observed in 3-year overall survival (OS) between SF and AF. Grade 3 or 4 acute and late toxicities developed in 22 (12.4%)/21 (11.5%) and 2 (1.1%)/1 (0.5%) in the SF/AF arms.

Conclusion:

Although the non-inferiority of AF was not confirmed statistically, the similar efficacy and toxicity of AF compared with SF, as well as the practical convenience of its fewer treatment sessions, suggest the potential of AF as a treatment option for early GC.

Clinical trials registration:

UMIN Clinical Trial Registry, number UMIN000000819.

PMID:
29401241
DOI:
10.1093/annonc/mdy036

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