UMIN-CTR Clinical Trial

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

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

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Yokohama City University Hospital

Institute

Department

Personal name

Organization

Yokohama City University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

03

Month

22

Day

Last modified on

2019

Year

09

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036355