UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002168 |
|---|---|
| Receipt number | R000002657 |
| Scientific Title | Phase II trial of S-1 with concurrent radiotherapy in T2N0M0 laryngeal, mesopharynx, hypopharynx cancer |
| Date of disclosure of the study information | 2009/07/18 |
| Last modified on | 2015/01/13 10:16:14 |
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Basic information
Public title
Phase II trial of S-1 with concurrent radiotherapy in T2N0M0 laryngeal, mesopharynx, hypopharynx cancer
Acronym
Phase II trial of S-1 with concurrent radiotherapy in T2N0M0 laryngeal, mesopharynx, hypopharynx cancer
Scientific Title
Phase II trial of S-1 with concurrent radiotherapy in T2N0M0 laryngeal, mesopharynx, hypopharynx cancer
Scientific Title:Acronym
Phase II trial of S-1 with concurrent radiotherapy in T2N0M0 laryngeal, mesopharynx, hypopharynx cancer
Region
| Japan |
Condition
Condition
head and neck cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and toxicity of S-1 plus concurrent radiotherapy in patients with T2N0M0 laryngeal, mesopharynx, hypopharynx cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
local control rate
Key secondary outcomes
response rate, treatment completion rate, local control time, progression free time, overall survival, safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
S-1 is administered orally at 60 mg/m2 for 14 consecutive days followed by a 7 days rest. A total radiation dose of 70 Gy is planned with conventional fractionation (1.8-2.0Gy/day). Cycles are repeated every 3 weeks until 3 courses.
At a radiation dose of 40 Gy, tumor evaluation is carried out intermediary by inspection or image. If patient is in partial response or complete response, concurrent chemoradiation is continued until 70 Gy. 8 weeks after the end of treatment, tumor evaluation is carried out by imaging and biopsy. If remaining cancer cell is detected, patient have a operation.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)histologically or cytologically confirmed squamous cell carcinoma
2)stage II (T2N0M0) laryngeal, mesopharunx, and hypopharynx cancer with no evidence of distance metastases.
3)age: >=20 and <80
4)with measurable region
5)without prior treatment
6)Performance Statues: 0-1(ECOG)
7)sufficient function of important organs
a)WBC: >=4,000/mm3 and <=12,000/mm3
b)Neutrophyl: >=2,000/mm3
c)Platelet: >=100,000/mm3
d)Hemoglobin: >=10g/dl
e)GOT, GPT: 2.0 times of normal range in each institute
f)ALP: 2.0 times of normal range in each institute
g)sT.bil: 2.0 times of normal range in each institute
h)sCreatinin: normal range in each institute
i)Ccr: >=60 ml/min/body
8)expected more than 3 months survival from drug administration
9)written informed consent
10)with ability of oral intake
Key exclusion criteria
1)with active double cancer
2)with severe complications (congested heart failure, coronary insufficiency, myocardial infarction, angina pectoris or abnormal cardiac rhythm which need to treat, history of cerebrovascular accident, hemorrhagic gastrointestinal ulceration, uncontrolled diabetes, renal failure, active hepatitis, liver cirrhosis)
3)with develop fever and suspected infection
4)with motor palsy, peripheral neuropathy or edema (exclude the disorder which derives from primary disease)
5)with pleural effusion which need to treat or pericardial effusions
6)pregnant or nursing women or women who like be pregnant and men with partner willing to get pregnant
7)with interstitial pneumonitis which is revealed from chest X ray and chest CT
8)with history of mental disorder or treating it at the moment
9)with history of severe allergy
10)with severe allergy to S-1
11)patients receiving 5-FU based chemotherapy
12)patients receiving Flucytosine
13)doctor's decision not to be registered to this study
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhiko Oridate |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Biology and Function in the Head and Neck
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama,236-0004
TEL
045-787-2687
noridate@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahide Taguchi |
Organization
Yokohama City University Hospital
Division name
Department of Otorhinolaryngology
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama,236-0004
TEL
045-787-2687
Homepage URL
ttaguchi@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
横浜市立大学附属病院（神奈川県）、横浜市立大学附属市民総合医療センター（神奈川県）、神奈川県立がんセンター（神奈川県）、藤沢市民病院（神奈川県）、横浜南共済病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 07 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
From August 2009 to October 2012, 37 patients were evaluated for the study. The overall response rate was 100%. The 3-year local control rate was 89.0% (95% confidence interval (CI), 78.9-99.2%), and the 3-year overall survival rate was 97.2% (95% CI, 91.8-100%). Mucositis and dermatitis in the radiation field were the most common acute adverse events observed. The rates of Grade 3 mucositis and dermatitis were 27% and 35%, respectively. No patients experienced Grade 4 acute adverse events. The treatment completion rate was 89.2%
As a conclusion, CCRT with S-1 was safe and effective in improving local control for stage II SCC of the pharynx or larynx.
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
Completed
Date of protocol fixation
| 2009 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 07 | Day |
Last modified on
| 2015 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002657
