UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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 (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	Makoto Tahara, MD, PhD
Organization	National Cancer Center Hospital East
Division name	Div. of Head and neck Medical Oncology
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	Akira Yamao
Organization	Public health research foundation
Division name	Executive office of Comprehensive Support Project for Oncology Research
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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