JCOG1008: 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
- Conditions
- locally advanced squamous cell carcinoma of the head and neck
- Registration Number
- JPRN-jRCTs031180135
- Lead Sponsor
- TAHARA Makoto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 260
1) Histologically proven squamous cell carcinoma in resected specimen
2) Primary lesion located at oral cavity, oropharynx, hypopharynx, or larynx. Primary site is diagnosed by surgical specimen.
3) Pathological stage III, IVA or IVB (UICC 7th edition)
4) high risk of locoregional recurrence defined as fulfilling i) and/or ii) by histological examination of surgical specimen
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
1) Simultaneous or metachronous (within 5 years) double cancers except carcinoma in situ or intramucosal tumor with local therapy, and endoscopically confirmed carcinoma in situ or intramucosal tumor of esophagus, stomach and colorectum before registration.
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) Patients who have psychosis or psychiatric symptoms are judged not to be able to participate in this clinical study
6) Continuous systemic steroid treatment (internal or intervenous use)
7) Uncontrolled diabetes mellitus
8) History of unstable angina pectoris (onset or worsening angina attack within 3 weeeks or a history of 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival (phase III)<br>proportion of treatment completion (phase II)
- Secondary Outcome Measures
Name Time Method 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