Unique ID issued by UMIN | UMIN000014430 |
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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 |
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
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)
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
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)
Japan |
Head and Neck cancer
Medicine in general | Hematology and clinical oncology | Oto-rhino-laryngology |
Radiology |
Malignancy
NO
evaluating the feasibility of PCE followed by RT-CDDP in patients with LA-SCCHN who have had no prior treatment
Safety,Efficacy
Confirmatory
Phase II
Proportion of chemoradiation completion
Response rate, Frequency and types of adverse events, Time-to-local progression,
Time-to-distant metastasis, Event-free survival, Overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Maneuver |
Paclitaxel, Carboplatin and Cetuximab (PCE) followed by Cisplatin and Radiation
20 | years-old | <= |
75 | years-old | >= |
Male and Female
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.
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.
34
1st name | |
Middle name | |
Last name | Makoto Tahara |
National Cancer Center Hospital East
Division of Head and Neck Medical Oncology
6-5-1,Kashiwanoha,Kashiwa-shi,Chiba,277-8577 Japan
+81-4-7133-1111
matahara@east.ncc.go.jp
1st name | |
Middle name | |
Last name | Tomohiro Enokida |
National Cancer Center Hospital East
Division of Head and Neck Medical Oncology
6-5-1,Kashiwanoha,Kashiwa-shi,Chiba,277-8577 Japan
+81-4-7133-1111
tenokida@east.ncc.go.jp
IC-PCE study executive committee
National Cancer Center Hospital
Other
NO
2014 | Year | 07 | Month | 02 | Day |
Unpublished
Enrolling by invitation
2014 | Year | 06 | Month | 13 | Day |
2014 | Year | 06 | Month | 14 | Day |
2017 | Year | 05 | Month | 31 | Day |
2017 | Year | 12 | Month | 01 | Day |
2018 | Year | 04 | Month | 01 | Day |
2018 | Year | 10 | Month | 31 | Day |
2014 | Year | 06 | Month | 30 | Day |
2014 | Year | 07 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016783
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