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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023416
Receipt No. R000026930
Scientific Title Prospective Study of Concurrent Chemoradiotherapy with S-1 and hypofractionated radiotherapy for outpatients with early glottic squamous cell carcinomas
Date of disclosure of the study information 2016/08/31
Last modified on 2016/09/21

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Basic information
Public title Prospective Study of Concurrent Chemoradiotherapy with S-1 and hypofractionated
radiotherapy for outpatients with early glottic squamous cell carcinomas
Acronym Prospective Study of Concurrent Chemoradiotherapy with S-1 and hypofractionated
radiotherapy for outpatients with early glottic squamous cell carcinomas
Scientific Title Prospective Study of Concurrent Chemoradiotherapy with S-1 and hypofractionated
radiotherapy for outpatients with early glottic squamous cell carcinomas
Scientific Title:Acronym Prospective Study of Concurrent Chemoradiotherapy with S-1 and hypofractionated
radiotherapy for outpatients with early glottic squamous cell carcinomas
Region
Japan

Condition
Condition T1 bulky/T2 favorable Glottic carcinoma, squamous cell carcinoma
Classification by specialty
Oto-rhino-laryngology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The recommended treatment strategies for early glottis carcinoma (GC) with intent of larynx preservation are mainly radiotherapy (RT), transoral laser therapy and partial laryngonectomy. However, the outcomes of RT alone for T1 bulky or T2 GC are unsatisfactory. We deigned the protocol of chemoradiotherapy (CCRT) using S-1 as the radiosensitizer and we have performed the CCRT with patients with T2 favorable. In our protocol of CCRT with S-1, S-1 was taken orally once daily after breakfast and RT with 2 Gy/ day, five days/ week, to a total of 30 fractions (total dose of 60 Gy). We have showed the efficacy and safety of this protocol. Thus, with the aim of improving the local control rate with primary RT and shortening the treatment period, we changed the dose of radiation in our protocol of CCRT using S-1 from 2 Gy per fraction, a total of 30 fractions, to 2.25 Gy per fraction, a total of 25 fractions. The present study concept is to evaluate the efficacy and safety of the new protocol.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 3-year local control rate
Key secondary outcomes

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 Maneuver
Interventions/Control_1 Treatment schedule: S-1 is taken orally once daily after breakfast and radiotherapy (RT) with 2.25 Gy/day, five days/week, to a total of 25 fractions (total dose of 56.25 Gy), is delivered. Oral S-1 and RT is started on the same day, on Monday in principle, and RT is performed between 3 and 6 hours after oral administration of S-1. S-1 is not administered on Saturdays or Sundays, when RT is not performed. The dose of S-1 is 55.3 mg/m2/day.
Radiotherapy: Conventional RT was performed with 4-MV photons at 2.25 Gy/fraction/day. The total dose delivered is 56.25 Gy/25 fractions over a 5-week period. RT was planned for all patients after appropriate immobilization, with a thermoplastic mask and 3D CT-based techniques. Two parallel-opposed lateral fields are used with a pair of wedge filters. The field size is reduced after administration of 45 Gy according to reduction of the size of tumor.
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) the primary site confirmed at glottis by laryngoscopy in 28 days before enrollment; (2) the T-stage diagnosed as bulky T1 or T2 without impaired cord mobility by laryngoscopy; (3) histologically- or cytologically- confirmed glottic squamous carcinoma; (4) Confirmed as N0M0 by chest X-ray or contrast-enhanced computer tomography; (5) no prior chemotherapy for malignancy within 5 years; (6) aged 20-80 years; (7) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; (8) no prior history of radiotherapy or surgery to the planned irradiation area; (9) willing to participate and sign informed consent; (10) adequate bone marrow, liver, and kidney functions.
Key exclusion criteria (1) unable to take oral S-1; (2) with a history of severe allergy; (3) severe clinical infection; (4) with active double cancer including simultaneous cancer or metachronous cancer within 5 years, except for in situ or intramucosal carcinoma; (5) being pregnant or breast feeding; (6) with mental disease interfering participating the trial; (7) with severe bone marrow dysfunction; (8) with the history of kidney disease, such as getting dialysis; (9) with the history of severe liver disease; (10)with the history of severe lung disease, such as interstitial pneumonia of pulmonary fibrosis; (11) with the history of collagen disease; (12) with uncontrolled diabetes mellitus or insulin-dependent diabetes mellitus; (13) with uncontrolled hypertension; (14) cardiovascular diseases with clinical significance, such as heart failure, history of myocardial infarction or angina in the past half year; (15) taking drugs as follows; other pyrimidine compound- anticancer drug or flucytosine ; (16) jugged as inadequate case by doctor in charge.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Itoh
Organization Nagoya University Graduate School of Medicine
Division name Department of Radiology
Zip code
Address 65 Tsurumai-cho, Shouwa-ku, Nagoya, Aichi 466-8550, Japan
TEL 052-744-2328
Email itoh@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Itoh
Organization Nagoya University Graduate School of Medicine
Division name Department of Radiology
Zip code
Address 65 Tsurumai-cho, Shouwa-ku, Nagoya, Aichi 466-8550, Japan
TEL 052-744-2328
Homepage URL
Email itoh@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine, Department of Radiology
Institute
Department

Funding Source
Organization Nagoya University hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Preinitiation
Date of protocol fixation
2016 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 31 Day
Last modified on
2016 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026930

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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