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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000014070 |
Receipt No. | R000016379 |
Scientific Title | Clinical study on the effect of adjuvant chemotherapy using TS-1 in the treatment of salivary gland carcinoma |
Date of disclosure of the study information | 2014/06/01 |
Last modified on | 2014/05/26 |
Basic information | ||
Public title | Clinical study on the effect of adjuvant chemotherapy using TS-1 in the treatment of salivary gland carcinoma | |
Acronym | Adjuvant chemotherapy for salivary gland carcinoma | |
Scientific Title | Clinical study on the effect of adjuvant chemotherapy using TS-1 in the treatment of salivary gland carcinoma | |
Scientific Title:Acronym | Adjuvant chemotherapy for salivary gland carcinoma | |
Region |
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Condition | ||
Condition | Salivary gland carcinoma | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To assess whether adjuvant chemotherapy using TS-1 can improve prognosis in the patients with salivary gland carcinoma. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase II,III |
Assessment | |
Primary outcomes | Overall survival time |
Key secondary outcomes | Disease free survival time, Distant metastasis free survival time, adverse effect |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | No treatment |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Adjuvant chemotherapy (TS-1, one year) | |
Interventions/Control_2 | no adjuvant chemotherapy | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key 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. |
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Key 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 |
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Target sample size | 180 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Shinshu University School of Medicine | ||||||
Division name | Department of Dentistry and Oral Surgery | ||||||
Zip code | |||||||
Address | Asahi 3-1-1, Matsumoto | ||||||
TEL | 0263-37-2677 | ||||||
hkurita@shinshu-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Shinshu University School of Medicine | ||||||
Division name | Department of Dentistry and Oral Surgery | ||||||
Zip code | |||||||
Address | Asahi 3-1-1, Matsumoto | ||||||
TEL | 0263-37-2677 | ||||||
Homepage URL | |||||||
hkurita@shinshu-u.ac.jp |
Sponsor | |
Institute | Department of Dentistry and Oral Surgery, Shinshu University School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Department of Dentistry and Oral Surgery, Shinshu University School of Medicine |
Organization | |
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IRB Contact (For public release) | |
Organization | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016379 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |