Skip to content

To adjuvant chemotherapy after curative treatment of head and neck cancer A study of alternate-day administration definitive TS-1

To adjuvant chemotherapy after curative treatment of head and neck cancer A study of alternate-day administration definitive TS-1 - Phase II of the TS-1 every other day dosing regimen in head and neck cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009856
Enrollment
55
Registered
2013-01-24
Start date
2013-02-01
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

Head and neck cancer

Interventions

TS-1 performed in alternate-day dosing

Sponsors

National Center for Global health and Medicine Otolarygology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Intended for cases corresponding to all of the following items. 1)Cases would be diagnosed with squamous cell carcinoma (except thyroid) primary tumor by histological or cytological diagnosis, curative treatment was performed.In addition, diagnostic imaging(chest X-ray, ultrasound, CT, MRI, such as PET) after two months followed by radiotherapy treatment and surgery (including combination therapy chemoradiation therapy) curative Tumor Free will be confirmed by it is defined as Ru. 2)Maxillary sinus, oral cavity, oropharynx , primary site, larynx (T3N0 glottic excluded) case is it or hypopharynx 3)Cases of IV A , IV B Stage III Stage or clinical or pathological stage 4)Case you do not have anti-cancer treatment until after the end of curative treatment initial registration 5)Patient age at the time of obtaining informed consent is 20 years of age or older 6)0-1 is a case: (PS Performance status) general condition 7)capable of oral intake 8)Patients with the following conditions are met in the bone marrow within 14 days prior to enrollment, liver and renal function i)WBC:>=3,500/mm3,<12,000/mm3 ii)neutrophil:>=1,500/mm3 iii)blood platelet:>=100,000mm3 iv)hemoglobin:>=9.0g/dL v)total bilirubin:=2.0mg/dL vi)AST(GOT):<=100IU/L ALT(GPT):<=100IU/L vii)Creatinine clearance:>= case is greater than or equal to 60ml/min

Exclusion criteria

Exclusion criteria: 1)It is contraindicated in patients with the administration of TS-1 2)Cases that are complicated by infection requiring treatment 3)Gastrointestinal disease with treatment (intestinal paralysis, intestinal obstruction, etc.) Patients with 4)Patients with interstitial pneumonitis or pulmonary fibrosis 5)Patients with diabetes 6)Patients with heart disease 7)Patients with (watery) diarrhea 8)Patients attending physician was deemed inappropriate as the subject of the study for other reasons

Design outcomes

Primary

MeasureTime frame
Completion percentage administration

Secondary

MeasureTime frame
Adverse event, Total dose for dose planning ,survival, recurrence-free survival

Countries

Japan

Contacts

Public ContactTakahiro Asakage

Hospital School of Medicine,University of Tokyo Otolarygology,Auditory speech surgery

03-5800-8665

Outcome results

None listed

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