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

Multi-institutional Phase IIa Trial of Postoperative Chemoradiotherapy Using Hyperfractionated Intensity-modulated Radiotherapy and Weekly Cisplatin in High Risk Patients with Head and Neck Squamous Cell Carcinoma.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051210100

Enrollment

Registered

2021-10-06

Start date

2021-10-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck squamous cell carcinoma

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria: Patients with p16 positive oropharyngeal carcinoma.

Design outcomes

Primary

Measure	Time frame
Completion rate of treatment	—

Secondary

Measure	Time frame
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	—

Contacts

Public ContactShinya Hiraoka

Kyoto University Hospital

shiraok@kuhp.kyoto-u.ac.jp+81-75-751-3762

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026