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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031835
Receipt No. R000036355
Scientific Title The efficacy of postoperative bio-chemoradiotherapy using cetuximab and docetaxel for cis-platinum intolerant high-risk head and neck cancer patients.
Date of disclosure of the study information 2018/04/01
Last modified on 2019/09/24

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Basic information
Public title The efficacy of postoperative bio-chemoradiotherapy using cetuximab and docetaxel for cis-platinum intolerant high-risk head and neck cancer patients.
Acronym The efficacy of postoperative B-CRT using Cmab and DTX for CDDP intolerant high-risk head and neck cancer patients.
Scientific Title The efficacy of postoperative bio-chemoradiotherapy using cetuximab and docetaxel for cis-platinum intolerant high-risk head and neck cancer patients.
Scientific Title:Acronym The efficacy of postoperative B-CRT using Cmab and DTX for CDDP intolerant high-risk head and neck cancer patients.
Region
Japan

Condition
Condition The efficacy of postoperative bio-chemoradiotherapy using cetuximab and docetaxel for cis-platinum intolerant high-risk head and neck cancer patients.
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 For the advanced head and neck cancer patients, surgery is a common definitive therapy. After surgery, pathological evaluation is necessary for the decision of additional therapy. The pathological results of microscopically involved surgical margin of the primary site and/or extracapsular extension of the lymph nodes are considered to be core high-risk factors indicating poor prognosis. The outcome for patients with these high-risk factors may be improved by concurrent chemotherapy in additional administration during postoperative radiotherapy. The standard protocol for the postoperative chemoradiotherapy is the concurrent use of cis-platinum (CDDP) during radiotherapy for previous described high-risk patients. However, many of these patients are intolerant to CDDP, and one option to overcome these problems is the combined administration of cetuximab (Cmab) and docetaxel (DTX) during postoperative radiotherapy. We tried combination use of Cmab and DTX during postoperative radiotherapy for CDDP intolerant high-risk head and neck cancer patients in limited number and revealed the safety. Here we propose this trial to confirm the efficacy of postoperative bio-chemoradiotherapy using Cmab and DTX for CDDP intolerant high-risk head and neck cancer patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 2-year disease free survival
Key secondary outcomes 2-year overall survival, 2-year recurrence free survival, and 2-year locoregional control 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
Interventions/Control_1 Radiotherapy is delivered in conventional fractions of 1.8 Gy to a total dose of 66.6 Gy, 5 days per week, using 4-6 MV X-rays. The radiation fields are set up as the primary tumor and, prophylactically, the bilateral cervical lymph node area. The cervical lymph node area is received prophylactic doses of 45 Gy with lateral opposed fields to upper neck and anterior lower neck. The bio-chemotherapy regimen consists of weekly Cmab (week 1: 400mg/m2; subsequent weeks: 250 mg/m2) and DTX (25mg/m2).
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 Prior to enrollment in this trial, the patients must meet all of the following criteria: pathologically proven carcinoma; primary tumor located in the nasal/paranasal sinus, oral cavity, larynx, oropharynx and hypopharynx; clinically advanced stage (stage III or IV) on visual and endoscopic examinations and imaging examinations; e.g., CT, magnetic resonance imaging (MRI), ultrasonic echo (US) and/or PET-CT; primary site assessed as resectable by definitive surgery and regional lymph node by neck dissection on CT, MRI and/or US; no distant metastasis on PET-CT (cM0); aged over 20 years old (regarded as legally adult in Japan); PS 0-2 on ECOG criteria; sufficient general condition for the operation under general anesthesia; CDDP intolerant; e.g., advanced age (over 75-year-old), poor renal function (e-GFR < 60 ml/min/1.73m2), insufficient bone marrow function (white blood cell count < 3,000/mm3, neutrophil count < 1,500/mm3, platelet count < 7.5x104/mm3), hearing impairment, drug allergy, past history of CDDP use and/or poor general condition; and provision of written informed consent.
Key exclusion criteria Prior to enrollment in this trial, the patients must not meet any of the following criteria: uncurable synchronous malignancies, priority systemic diseases, and refusal to undergo the definitive surgery and/or postoperative radiotherapy.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiko Oridate
Organization Yokohama City University, School of Medicine
Division name Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004
TEL 045-787-2687
Email noridate@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Goshi Nishimura
Organization Yokohama City University, School of Medicine
Division name Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004
TEL 045-787-2687
Homepage URL
Email gnishimu@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

Funding Source
Organization Yokohama City University 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
2018 Year 04 Month 01 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
2018 Year 03 Month 05 Day
Date of IRB
2018 Year 03 Month 05 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 22 Day
Last modified on
2019 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036355

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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