UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014632 |
|---|---|
| Receipt number | 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 09:09:50 |
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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
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
nakazawa@dent.osaka-u.ac.jp
Public contact
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
nakazawa@dent.osaka-u.ac.jp
Sponsor or person
Institute
The workshop of chemotherapy for oral cancer
Institute
Department
Personal name
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
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
Value
https://center6.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 |
