Phase II trial of chemoradiotherapy concurrent with S-1 plus cisplatin in patients with unresectable locally advanced squamous cell carcinoma of the head and neck (JCOG0706)

Phase II trial of chemoradiotherapy concurrent with S-1 plus cisplatin in patients with unresectable locally advanced squamous cell carcinoma of the head and neck (JCOG0706) - Phase II trial of chemoradiotherapy concurrent with S-1 plus cisplatin in patients with unresectable locally advanced squamous cell carcinoma of the head and neck (JCOG0706)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001272

Enrollment

Registered

2008-07-28

Start date

2008-07-01

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

unresectable locally advanced squamous cell carcinoma of the head and neck

Interventions

Concurrent chemoradiotherapy with S-1 and cisplatin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven squamous cell carcinoma 2) Primary lesion located at oropharynx, hypopharynx, or larynx 3) Unrespectable locally advanced head and neck cancer 4) No fistula of primary lesion or cervical lymph node metastasis 5) No distant metastasis 6) Aged 20 to 75 years old 7) Performance status of 0 or 1 8) No prior radical surgery for head and neck cancer 9) No prior treatment of chemotherapy, radiation therapy, or endocrine tumor against any other malignancies 10) Adequate organ functions defined as indicated below; (1) WBC >= 4,000 /mm3 , WBC <= 12,000 /mm3, (2) Plt >=100,000 /mm3, (3) Hb >=9.5 g/dL, (4) Ccr >= 60 mL/min, (5) Cr <= 1.2 mg/dL, (6) AST <= 100 IU/L, (7) ALT <= 100 IU/L, (8) T.Bil <= 2.0 mg/dL 11) Normal electrocardiogram 12) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Active bacterial or fungous infection 2) Simultaneous or metachronous (within 5 years) double cancers except carcinoma in situ or intramucosal tumor. 3) Pregnant or lactating women or women of childbearing potential 4) Active gastrointestinal bleeding 5) Pleural effusion, pericardial effusion, or severe ascites 6) History of severe heart disease, heart failure, myocardial infarction within 6 months or attack of angina pectoris within 6 months. 7) Cerebrovascular disease within 6 months 8) Uncontrollable diabetes mellitus or requiring administration of insulin 9) Uncontrollable hypertension 10) Chronic pancreatitis 11) Positive HBs antigen 12) Impossible to refrain from smoking and drinking during treatment 13) Requiring systemic steroids medication

Design outcomes

Secondary

Measure	Time frame
local progression-free survival, progression-free survival, time to treatment failure, overall survival, proportion of nutritional support-free survival, adverse events	—

Primary

Measure	Time frame
complete clinical remission rate	—

Countries

Japan

Contacts

Public ContactMakoto Tahara

JCOG0706 Coordinating Office Department of gastrointestinal onclolgy, National Cancer Center Hospital East

JCOG_sir@ml.jcog.jp04-7133-1111

Outcome results

None listed

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