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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014632
Receipt No. R000017008
Scientific Title The phase II study of induction chemotherapy with cetuximab/S-1/low dose cisplatin for oral squamous cell carcinoma patients
Date of disclosure of the study information 2014/07/25
Last modified on 2018/07/27

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Basic information
Public title The phase II study of induction chemotherapy with cetuximab/S-1/low dose cisplatin for oral squamous cell carcinoma patients
Acronym Induction chemotherapy with cetuximab/S-1/low dose cisplatin for oral squamous cell carcinoma patients
Scientific Title The phase II study of induction chemotherapy with cetuximab/S-1/low dose cisplatin for oral squamous cell carcinoma patients
Scientific Title:Acronym Induction chemotherapy with cetuximab/S-1/low dose cisplatin for oral squamous cell carcinoma patients
Region
Japan

Condition
Condition oral squamous cell carcinoma
Classification by specialty
Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to evaluate the safety and efficacy of induction chemotherapy with cetuximab/S-1/low dose cisplatin for oral squamous cell carcinoma patients.
This study is multi-center open label trial carried out at eight hospitals.
The patients with OSCC (stage II-IV, primary tumor size is more than 3cm) will be enrolled and received chemotherapy for 2 weeks and followed by definitive surgery.
We investigate antitumor effect and adverse effects, and evaluate the usefulness of this chemotherapy as induction manner.
Moreover we evaluate the effect for survival and QOL by function preserving surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes histological effect (histological response rate)
Key secondary outcomes overall survival, disease-free survival, complication after surgery, the rate of avoidance of reconstructive surgery

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Induction chemotherapy
Cetuximab day1(400mg/m2), day 8 (250mg/m2)
S-1 day 1-14 (80mg/m2)
CDDP day 1-5,8-12 (5mg/m2)
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) histologically confirmed SCC
2) measurable and evaluable tumor
3) untreated case with more than large T2 (maximum size >3cm) tumor
4) Performance status 0-1
5) The functions of main organ (bone marrow, heart, lung, liver, kidney) are almost normal.
Key exclusion criteria 1) double cancer case
2) severe systemic complications
3) metastasis to CNS
4) ischemic heart disease
5) active gastrointestinal ulcer
6) severe mental disorder
7) women who are fertile or during pregnancy
8) past illness of severe drug allergy
9) attending doctor's decision as unsuitable patient for this study
Target sample size 55

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Nakazawa
Organization Osaka university Graduate school of dentistry
Osaka university dental hospital
Division name 2nd dept. of oral & maxillofacial surgery
Zip code
Address 1-8 Yamadaoka Suita Osaka
TEL 06-6879-2941
Email nakazawa@dent.osaka-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Mitsuhiro Nakazawa
Organization Osaka university dental hospital
Division name 2nd dept. of oral & maxillofacial surgery
Zip code
Address 1-8 Yamadaoka Suita Osaka
TEL 06-6879-2941
Homepage URL
Email nakazawa@dent.osaka-u.ac.jp

Sponsor
Institute The workshop of chemotherapy for oral cancer
Institute
Department

Funding Source
Organization None
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 大阪大学歯学部附属病院(大阪府)、市立池田病院(大阪府)、市立東大阪医療センター(大阪府)、りんくう総合医療センター(大阪府)、市立伊丹病院(兵庫県)、明和病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 25 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 Completed
Date of protocol fixation
2014 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2019 Year 08 Month 31 Day
Date of closure to data entry
2019 Year 08 Month 31 Day
Date trial data considered complete
2019 Year 08 Month 31 Day
Date analysis concluded
2019 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 24 Day
Last modified on
2018 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017008

Research Plan
Registered date File name
2018/02/05 Cmab+TS1+CDDP臨床試験実施要項.doc

Research case data specifications
Registered date File name
2018/02/05 症例調査票1 (Cmab・S-1・CDDP)改訂.doc

Research case data
Registered date File name


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