Phase II/III Trial of Postoperative Chemoradiotherapy Comparing 3-Weekly Cisplatin with Weekly Cisplatin in High-risk Patients with Squamous Cell Carcinoma of Head and Neck (JCOG1008, HNC-Adjuvant CDDP+RT-P3)

Phase II/III Trial of Postoperative Chemoradiotherapy Comparing 3-Weekly Cisplatin with Weekly Cisplatin in High-risk Patients with Squamous Cell Carcinoma of Head and Neck (JCOG1008, HNC-Adjuvant CDDP+RT-P3) - Phase II/III Trial of Postoperative Chemoradiotherapy Comparing 3-Weekly Cisplatin with Weekly Cisplatin in High-risk Patients with Squamous Cell Carcinoma of Head and Neck (JCOG1008, HNC-Adjuvant CDDP+RT-P3)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009125

Enrollment

260

Registered

2012-10-16

Start date

2012-10-16

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

locally advanced squamous cell carcinoma of the head and neck

Interventions

A: Concurrent chemoradiotherapy with 3-Weekly CDDP (CDDP 100 mg/m2:day 1, 22, 43, fractionated radiation therapy: 66 Gy/33 Fr

Both 3D-CRT and IMRT are allowed.) B:Concurrent chemoradiotherapy with Weekly CDDP (CDDP 40 mg/m2:day 1, 8, 15, 22, 29, 36, 43, fractionated radiation therapy: 66 Gy/33 Fr

Both 3D-CRT and IMRT are allowed.)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven squamous cell carcinoma in resected specimen 2) Primary lesion located at oral cavity, oropharynx, hypopharynx, or larynx. 3) Pathological stage III, IVA or IVB (UICC 7th edition) 4) high risk of locoregional recurrence defined as fulfilling i) and/or ii) by pathological specimen after tumor resection and neck lymph node dissection i) Microscopically positive resection margin ii) Extracapsular nodal extension 5) Within 56 days from surgery. 6) No distant metastasis in computed tomography within 28 days before registration 7) Aged 20 to 75 years old 8) ECOG performance status (PS) of 0 or 1. 9) No prior radiation therapy, chemotherapy, nor hormonal therapy 10) Adequate organ functions 11) No clinically significant abnormal findings on electrocardiogram (ECG) within 28 days from the date of registration 12) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Simultaneous or metachronous (within 5 years) double cancers except carcinoma in situ or intramucosal tumor. 2) Active systemic infections to be treated. 3) Body temperature of 38 or more degrees Celsius 4) Women during pregnancy, possible pregnancy, or breast-feeding 5) Psychiatric disease 6) Continuous systemic steroid treatment 7) Uncontrolled diabetes mellitus 8) History of unstable angina pectoris or myocardial infarction within 6 months 9) Uncontrolled hypertension 10) Pleural effusion, pericardiac effusion, or ascites to be drained 11) Positive HBs antigen 12) Impossiblility to refrain from smoking or drinking during protocol treatment

Design outcomes

Primary

Measure	Time frame
overall survival (phase III), proportion of treatment completion (phase II)	—

Secondary

Measure	Time frame
relapse-free survival, local relapse-free survival, nutrition support free survival, adverse events, non-hospitalized treatment period during permissible treatment period, non-hospitalized treatment period during 90 days after the start of protocol treatment	—

Countries

Japan

Contacts

Public ContactNaomi Kiyota

JCOG1008 Coordinating Office Department of Medical Oncology and Hematology, Kobe University Hospital

JCOG_sir@ml.jcog.jp078-382-5111

Outcome results

None listed

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