UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010507 |
|---|---|
| Receipt number | 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 17:07:22 |
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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
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
info@csp.or.jp
Sponsor or person
Institute
CSPOR-HN 02 executive committee
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012287
