Novel approach of prophylactic radiation to reduce toxicities comparing 2-step40 with 56-Gy simultaneous integrated boost intensity-modulated radiation therapy for locally advanced squamous cell carcinoma of the head and neck, an intergroup phase III trial (JCOG1912, NEW BRIDGE)

BMC Cancer · 13 authors, 10 centres

AI SUMMARY

FIDELITY 100%

POPULATIONPatients with clinical stage III-IVB locally advanced squamous cell carcinoma of the head and neck, excluding p16-positive oropharynx cancer

INTERVENTIONChemoradiotherapy with 70 Gy tumor dose and reduced prophylactic radiation of 40 Gy in 20 fractions for 4 weeks (2-step40) plus concurrent cisplatin 100 mg/m²

COMPARISONChemoradiotherapy with 70 Gy tumor dose and standard prophylactic radiation of 56 Gy in 35 fractions for 7 weeks using simultaneous integrated boost (SIB56) plus concurrent cisplatin 100 mg/m²

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AGENT 01 · STRUCTURED SUMMARY

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TL;DR

This multicenter phase III randomized trial protocol compares reduced-dose prophylactic radiation (40 Gy, 2-step40) versus standard-dose prophylactic radiation (56 Gy, SIB56) in patients with locally advanced squamous cell carcinoma of the head and neck. The trial is designed to test non-inferiority in time to treatment failure with the experimental arm, while evaluating whether reduced prophylactic dose decreases late toxicities.

Full summary

938 CHARS

This is a protocol paper for a multicenter, open-label, randomized phase III trial (JCOG1912, NEW BRIDGE) enrolling 400 patients from 52 Japanese institutions. Both arms receive 70 Gy to the tumor with concurrent cisplatin 100 mg/m² on days 1, 22, and 43. The standard arm delivers 56 Gy prophylactic radiation in 35 fractions over 7 weeks using simultaneous integrated boost IMRT, while the experimental arm delivers 40 Gy in 20 fractions over 4 weeks using a two-step method with a replanning CT at 30 Gy. The primary endpoint is time to treatment failure, testing non-inferiority of the experimental arm. The protocol includes mandatory quality assurance of radiation planning and prospective monitoring of ototoxicity, swallowing function, and thyroid function. The discussion notes that reduced prophylactic irradiation may spare draining lymph nodes, potentially benefiting future immune checkpoint inhibitor combination strategies.

PICO

PPOPULATION

Patients with clinical stage III-IVB locally advanced squamous cell carcinoma of the head and neck, excluding p16-positive oropharynx cancer

IINTERVENTION

Chemoradiotherapy with 70 Gy tumor dose and reduced prophylactic radiation of 40 Gy in 20 fractions for 4 weeks (2-step40) plus concurrent cisplatin 100 mg/m²

OOUTCOME

Primary: time to treatment failure; Secondary: overall survival, complete response rate, progression-free survival, locoregional relapse-free survival, acute and late adverse events, quality of life score, swallowing function score

STUDY TYPE

RCT

SPECIALTY

oncology

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10626703

Novel approach of prophylactic radiation to reduce toxicities comparing 2-step40 with 56-Gy simultaneous integrated boost intensity-modulated radiation therapy for locally advanced squamous cell carcinoma of the head and neck, an intergroup phase III trial (JCOG1912, NEW BRIDGE)

BMC Cancer

READ THE FULL PAPER

ABSTRACT

Background Chemoradiotherapy (CRT) with concurrent cisplatin is the standard of care as a nonsurgical definitive treatment for patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). However, CRT is associated with increased severe late adverse events, including swallowing dysfunction, xerostomia, ototoxicity, and hypothyroidism. Few strategies aimed at less invasive CRT without compromising treatment outcomes have been successful. The purpose of this study is to confirm the non-inferiority of reduced dose prophylactic radiation with 40 Gy compared to standard dose prophylactic radiation with 56 Gy in terms of the time to treatment failure (TTF) among patients with clinical stage III-IVB LA-SCCHN. Methods This study is a multicenter, two-arm, open-label, randomized phase III trial. Patients with LA-SCCHN excluding p16 positive oropharynx cancer are randomized to the standard arm or experimental arm. A total dose of 70 Gy for tumors with concurrent cisplatin at 100 mg/m 2 are administered in both arms. For prophylactic field, patients in the standard arm receive a total dose of 56 Gy in 35 fractions for 7 weeks using simultaneous integrated boost (SIB56) and those in the experimental arm receive 40 Gy in 20 fractions using two-step methods for 4 weeks (2-step40). A total of 400 patients will be enrolled from 52 Japanese institutions within 5 years. The primary endpoint is TTF, and the secondary endpoints are overall survival, complete response rate, progression-free survival, locoregional relapse-free survival, acute and late adverse events, quality of life score, and swallowing function score. Discussion If the experimental arm is non-inferior to the standard arm in terms of TTF and superior on the safety endpoints, the 2-step40 procedure is the more useful treatment than SIB56 for definitive CRT. Trial registration This trial has been registered in the Japan Registry of Clinical Trials as jRCTs031210100 ( https://jrct.niph.go.jp/latest-detail/jRCTs031210100 ). Date of Registration: May 2021. Supplementary Information The online version contains supplementary material available at 10.1186/s12885-023-11503-z.

CITATION EXPORT

Tomoya Yokota, Sadamoto Zenda, Takeshi Kodaira et al.. Novel approach of prophylactic radiation to reduce toxicities comparing 2-step40 with 56-Gy simultaneous integrated boost intensity-modulated radiation therapy for locally advanced squamous cell carcinoma of the head and neck, an intergroup phase III trial (JCOG1912, NEW BRIDGE). BMC Cancer. (2023). https://doi.org/10.1186/s12885-023-11503-z

AUTHORS

13 · 10 CENTRES

Tomoya Yokota, Sadamoto Zenda, Takeshi Kodaira, Naomi Kiyota, Yasushi Fujimoto, Koichiro Wasano, Ryo Takahashi, Takashi Mizowaki, Akihiro Homma, Keita Sasaki, Ryunosuke Machida, Yuta Sekino, Haruhiko Fukuda

1https://ror.org/0042ytd14grid.415797.90000 0004 1774 9501Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-gun, Japan
2https://ror.org/03rm3gk43grid.497282.2Department of Radiation Oncology, National Cancer Center Hospital East, Kashiwa, Japan
3https://ror.org/03kfmm080grid.410800.d0000 0001 0722 8444Department of Radiation Oncology, Aichi Cancer Center Hospital, Nagoya, Japan, 1-1 Kanoko-den, Chikusa-ku, Nagoya, Aichi 464-8681 Japan
4https://ror.org/00bb55562grid.411102.70000 0004 0596 6533Department of Medical Oncology and Hematology, Cancer Center, Kobe University Hospital, Kobe, Japan
5https://ror.org/02h6cs343grid.411234.10000 0001 0727 1557Department of Otolaryngology, Aichi Medical University, Nagakute, Japan
6https://ror.org/01p7qe739grid.265061.60000 0001 1516 6626Department of Otolaryngology-Head and Neck Surgery, Tokai University School of Medicine, Isehara, Japan
7https://ror.org/03rm3gk43grid.497282.2Section of Radiation Safety and Quality Assurance, National Cancer Center Hospital East, Kashiwa, Japan
8https://ror.org/02kpeqv85grid.258799.80000 0004 0372 2033Departments of Radiation Oncology and Image-Applied Therapy, Kyoto University Graduate School of Medicine, Kyoto, Japan
9https://ror.org/02e16g702grid.39158.360000 0001 2173 7691Department of Otolaryngology-Head and Neck Surgery, Faculty of Medicine, Graduate School of Medicine, Hokkaido University, Sapporo, Japan
10https://ror.org/03rm3gk43grid.497282.2Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan