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Clinical study on the effect of adjuvant chemotherapy using TS-1 in the treatment of salivary gland carcinoma

Clinical study on the effect of adjuvant chemotherapy using TS-1 in the treatment of salivary gland carcinoma - Adjuvant chemotherapy for salivary gland carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014070
Enrollment
180
Registered
2014-06-01
Start date
2014-06-01
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

Salivary gland carcinoma

Interventions

Adjuvant chemotherapy (TS-1, one year) no adjuvant chemotherapy

Sponsors

Department of Dentistry and Oral Surgery, Shinshu University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Proven salivary gland carcinoma 2) Having primary site in the oral and maxillofacial region excepting the parotid gland 3) Patients who underwent radical treatment with surgery 4) No evidence of distant metastasis 5) 20 years <=, <= 80 years old 6) ECOG performance status 0 or 1 7) Registration within 3 months after the primary treatment 8) No previous chemo- or radiotherapy (excepting salivary Ca). 9) Good and fair condition of major organs. 10) Possible of oral administration 11) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) The possibility (will) of the pregnancy and nursing girl 2) Active multiple primary 3) Having a mental disorder 4) Having a serious or life-threatening disease. 5) Having uncontrolled diarrhea 6) Systemic steroid use 7) Having infection 8) Having fever up over 38 degree Celsius 9) Severe allergic reaction for any drugs 10) Taking flucytosine 11) Patients who need flucytosine, phenytoin, or warfarin. 12) Anyone who was judged as unsuitable for this study

Design outcomes

Primary

MeasureTime frame
Overall survival time

Secondary

MeasureTime frame
Disease free survival time, Distant metastasis free survival time, adverse effect

Countries

Japan

Contacts

Public ContactHiroshi Kurita

Shinshu University School of Medicine Department of Dentistry and Oral Surgery

hkurita@shinshu-u.ac.jp0263-37-2677

Outcome results

None listed

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