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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014430
Receipt No. R000016783
Scientific Title Feasibility study evaluating Paclitaxel, Carboplatin and Cetuximab (PCE) as induction chemotherapy followed by chemoradiation in patients with Unresectable Locally advanced Squamous Cell Carcinoma of the Head and Neck
Date of disclosure of the study information 2014/07/02
Last modified on 2014/07/05

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Basic information
Public title Feasibility study evaluating Paclitaxel, Carboplatin and Cetuximab (PCE) as induction chemotherapy followed by chemoradiation in patients with Unresectable Locally advanced Squamous Cell Carcinoma of the Head and Neck
Acronym Feasibility study evaluating Paclitaxel, Carboplatin and Cetuximab (PCE) as induction chemotherapy followed by chemoradiation in patients with Unresectable Locally advanced Squamous Cell Carcinoma of the Head and Neck (IC-PCE)
Scientific Title Feasibility study evaluating Paclitaxel, Carboplatin and Cetuximab (PCE) as induction chemotherapy followed by chemoradiation in patients with Unresectable Locally advanced Squamous Cell Carcinoma of the Head and Neck
Scientific Title:Acronym Feasibility study evaluating Paclitaxel, Carboplatin and Cetuximab (PCE) as induction chemotherapy followed by chemoradiation in patients with Unresectable Locally advanced Squamous Cell Carcinoma of the Head and Neck (IC-PCE)
Region
Japan

Condition
Condition Head and Neck cancer
Classification by specialty
Medicine in general Hematology and clinical oncology Oto-rhino-laryngology
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 evaluating the feasibility of PCE followed by RT-CDDP in patients with LA-SCCHN who have had no prior treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Proportion of chemoradiation completion
Key secondary outcomes Response rate, Frequency and types of adverse events, Time-to-local progression,
Time-to-distant metastasis, Event-free survival, Overall survival

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 Paclitaxel, Carboplatin and Cetuximab (PCE) followed by Cisplatin and Radiation
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 or cytological proven squamous cell carcinoma of the head and neck.
2)Primary lesion located at the larynx,oropharynx or hypopharynx.
3)Unresectable LASCCHN.
4)No cancer fistula.
5)Measurable disease.
6)No evidence of distant metastasis.
7)ECOG PS 0 or 1.
8)Age between 20 and 75 years.
9)Adequate organ function.
10)HBsAg negative.
11)No abnormal finding on electrocardiogram.
12)Women of child bearing potential and men who are able to father a child agree with using adequate contraception.
13)Written informed consent to the study signed by the patient.
Key exclusion criteria 1)Primary lesion located at the nasopharynx, oral cavity, nasal cavity, parasinus or salivary gland.
2)Prior RT, CT or endocrine therapy for the current or any other malignancy .
3)Current other synchronous primary double cancers and metachronous double cancers unless free of disease for at least five years (excluding superficial cancer that will be cured by endoscopic mucosal resection).
4)Severe myelosuppressifon or infection.
5)Pulmonary fibrosis, acute lung injury or Intestinal pneumonia .
7)Active gastrointestinal bleeding.
8)Clinically relevant comorbidity included heart failure, renal failure, liver failure, uncontrolled hypertension or uncontrolled diabetes mellitus.
9)History of severe hypersensitivity.
10)Known hypersensitivity against any components of the trial treatment including excepients.
11)Pregnancy or breast feeding.
12)Current administration of disulfiram, Cyanamide, Carmofur or procarbazine hydrochloride.
13)Previous treatment with cetuximab or monoclonal antibody.
14)Other significant disease that in the investigator's opinion would exclude the subject from the trial.
Target sample size 34

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Tahara
Organization National Cancer Center Hospital East
Division name Division of Head and Neck Medical Oncology
Zip code
Address 6-5-1,Kashiwanoha,Kashiwa-shi,Chiba,277-8577 Japan
TEL +81-4-7133-1111
Email matahara@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Enokida
Organization National Cancer Center Hospital East
Division name Division of Head and Neck Medical Oncology
Zip code
Address 6-5-1,Kashiwanoha,Kashiwa-shi,Chiba,277-8577 Japan
TEL +81-4-7133-1111
Homepage URL
Email tenokida@east.ncc.go.jp

Sponsor
Institute IC-PCE study executive committee
Institute
Department

Funding Source
Organization National Cancer Center 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
2014 Year 07 Month 02 Day

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 Enrolling by invitation
Date of protocol fixation
2014 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 14 Day
Last follow-up date
2017 Year 05 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 01 Day
Date trial data considered complete
2018 Year 04 Month 01 Day
Date analysis concluded
2018 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 06 Month 30 Day
Last modified on
2014 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016783

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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