Multi-institutional Phase IIa Trial of Postoperative Chemoradiotherapy in High Risk Patients with Head and Neck Squamous Cell Carcinoma

JRCT ID: jRCTs051210100

Registered date:06/10/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Head and neck squamous cell carcinoma
• Date of first enrollment: 28/10/2021
• Target sample size: 10
• Study type: Interventional

Intervention(s)

Intensity-modulated radiation therapy (IMRT)
Encompassing the primary site and all draining lymph nodes at risk
50.6 Gy/44 fr./bid.
Regions at high risk
23 Gy/20 fr./bid.
Total 73.6 Gy

Cisplatin; administered by intravenous drip infusion every week at a dose of 40 mg/m2 for 7 weeks.

Outcome(s)

• Primary Outcome: Completion rate of treatment

Secondary Outcome

Grade 3 or higher non-hematological acute adverse event rate
Rate of laryngeal edema requiring urgent intervention such as tracheotomy or intubation
Severe adverse event rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. Tumor histology is confirmed as squamous cell carcinoma by surgically resected specimen.
2. Patients with oral, oropharyngeal, hypopharyngeal, or laryngeal carcinoma.
3. Patients detected either or both of i) and ii) by primary tumor resection and neck dissection.
i) Positive microscopic excisional margin.
ii) Extracapsular extension of cervical lymph node.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

• Exclude criteria: Patients with p16 positive oropharyngeal carcinoma.

Related Information

• Primary Sponsor: Mizowaki Takashi