Randomized Phase II/III Trial of Post-operative Chemoradiotherapy Comparing 3-Weekly Cisplatin with Weekly Cisplatin in High-risk Patients with Squamous Cell Carcinoma of Head and Neck: Japan Clinical Oncology Group Study (JCOG1008)

Abstract

A randomized Phase II/III study was launched in Japan to evaluate the non-inferiority of concurrent chemoradiotherapy with weekly cisplatin (40 mg/m 2 ) compared with concurrent chemoradiotherapy with 3-weekly cisplatin (100 mg/m 2 ) for post-operative high-risk patients with locally advanced squamous cell carcinoma of head and neck. This study began in October 2012, and a total of 260 patients will be accrued from 18 institutions within 5 years. The primary endpoint of the Phase II part is proportion of treatment completion and that of the Phase III part is overall survival. The secondary endpoints are relapse-free survival, local relapse-free survival, nutrition-support-free survival, non-hospitalized treatment period during permissible treatment period and adverse events. This trial was registered at the UMIN Clinical Trials Registry as UMIN 000009125 [http://www.umin.ac.jp/ctr/].

A meta-analysis of weekly cisplatin versus three weekly cisplatin chemotherapy plus concurrent radiotherapy (CRT) for advanced head and neck cancer (HNC)

“…It is important to proceed with a long-term follow-up of the chronic toxicities and survival events to explore which treatment could make patients benefit most. Kunieda F et al had launched a randomized phase II/III study in Japan [33], and we are looking forward to make further efforts for the research.…”

Weekly cisplatin chemotherapy dosing versus triweekly chemotherapy with concurrent radiation for head and neck squamous cell carcinoma

“…The ototoxicity and nephrotoxicity of high‐dose cisplatin is well known. Given the similarity between the 40 mg/m 2 weekly and 100 mg/m 2 triweekly patients in our cohorts, it is reasonable to continue to investigate this higher dose weekly regimen and clarity will be looked for from ongoing randomized trials such as JCOG 1008 …”

Adjuvant treatment for post-operative head and neck squamous cell carcinoma

“…However, a small randomized trial (26) showed significantly higher rates of radiation mucositis and overall toxicities for CRT with CDDP at 40 mg/m 2 . To clarify these discrepant findings for the safety and efficacy of 3-weekly and weekly schedules, we are now conducting a Phase II/III trial of postoperative chemoradiotherapy comparing 3-weekly with weekly cisplatin in high-risk patients with squamous cell carcinoma of the head and neck, the JCOG1008 study (UMIN Clinical Trial Registry number: 000009125) (27).…”