UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014430
Receipt number 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 18:11:20

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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 or person

Institute

IC-PCE study executive committee

Institute

Department

Personal name



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

Value
https://center6.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