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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010507
Receipt No. R000012287
Scientific Title Phase II trial of Combination with Paclitaxel, Carboplatin and Cetuximab (PCE) as a first line treatment in patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
Date of disclosure of the study information 2013/04/16
Last modified on 2018/10/03

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Basic information
Public title Phase II trial of Combination with Paclitaxel, Carboplatin and Cetuximab (PCE) as a first line treatment in patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
Acronym Phase II trial of Combination with Paclitaxel, Carboplatin and Cetuximab (PCE) as a first line treatment in patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (CSPOR-HN 02)
Scientific Title Phase II trial of Combination with Paclitaxel, Carboplatin and Cetuximab (PCE) as a first line treatment in patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
Scientific Title:Acronym Phase II trial of Combination with Paclitaxel, Carboplatin and Cetuximab (PCE) as a first line treatment in patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (CSPOR-HN 02)
Region
Japan

Condition
Condition Recurrent and/or metastatic squamous cell carcinoma of the head and neck
Classification by specialty
Hematology and clinical oncology Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Combination with Paclitaxel, Carboplatin and Cetuximab (PCE) in patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall response rate
Key secondary outcomes Safety, treatment completion rate, progression-free survival, overall survival, clinical benefit rate

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 Paclitaxel 100 mg/m^2/day1,8, every 3 weeks.
CBDCA AUC 2.5/day1,8, every 3 weeks, up to 6cycle.
Cetuximab loading dose 400 mg/m^2, followed by 250 mg/m^2, weekly, until disease progression.
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

Not applicable
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 oral cavity, oropharynx, hypopharynx, or larynx
3) Measurable disease according to RECIST ver1.1
4) Not amenable for local treatment for recurrent/ metastatic disease
5) ECOG performance status 0 or 1
6) Age >=20 at the time of informed consent
7) Adequate organ function
8) HBs Ag negative
9) Life expectancy of greater than 3 months
10) Women of child-bearing potential and men who are able to father a child agree with using adequate contraception
11) Written informed consent
Key exclusion criteria 1) Prior systemic chemotherapy except if given as a definitive multimodal treatment included induction chemotherapy, concurrent chemoradiotherapy and postoperative adjuvant chemoradiotherapy, which was completed more than 6 month prior to registration.
2)Prior surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before registration
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) Symptomatic brain metastasis
5) Severe myelosuppression or infection
6) Pulmonary fibrosis, acute lung injury or Intestinal pneumonia
7) Clinically relevant comorbidity included heart failure, renal failure, liver failure, uncontrolled hypertension or uncontrolled diabetes mellitus
8) History of severe hypersensitivity
9) Known hypersensitivity against any components of the trial treatment including excepients
10) Pregnancy or breast feeding
11) Other concomitant anticancer therapies
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 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Tahara, MD, PhD
Organization National Cancer Center Hospital East
Division name Div. of Head and neck Medical Oncology
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
TEL 04-7133-1111
Email matahara@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yamao
Organization Public health research foundation
Division name Executive office of Comprehensive Support Project for Oncology Research
Zip code
Address 1-1-7 Nishiwaseda, Shinjuku-ku, Tokyo, 169-0051 JAPAN
TEL 03-5287-2633
Homepage URL
Email info@csp.or.jp

Sponsor
Institute CSPOR-HN 02 executive committee
Institute
Department

Funding Source
Organization Merck Serono Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2013 Year 04 Month 16 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 Completed
Date of protocol fixation
2013 Year 05 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
2015 Year 10 Month 31 Day
Date of closure to data entry
2015 Year 10 Month 31 Day
Date trial data considered complete
2016 Year 07 Month 30 Day
Date analysis concluded
2017 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 04 Month 16 Day
Last modified on
2018 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012287

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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