UMIN-CTR Clinical Trial

Public title

Randomized phase II syudy of weekly docetaxel versus S-1 and concurrent radiothrapy for stage III and IV laryngeal, oropharyngeal, and hypopharyngeal cancer in elderly patients or patients with complications

Acronym

Phase II trial of concurrent chemoradiotherapy in elderly patients or patients with complications

Scientific Title

Randomized phase II syudy of weekly docetaxel versus S-1 and concurrent radiothrapy for stage III and IV laryngeal, oropharyngeal, and hypopharyngeal cancer in elderly patients or patients with complications

Scientific Title:Acronym

Phase II trial of concurrent chemoradiotherapy in elderly patients or patients with complications

Region

Japan

Condition

laryngeal, oropharyngeal,
and hypopharyngeal cancer

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the feasibility and the efficacy of radiotherapy and concurrent chemotherapy of S-1 (2 weeks administration and 1 week rest) or weekly docetaxel in patients with resectable advanced (stage III, IV) squamous cell carcinoma of the head and neck, who could not be administered high dose chemotherapy because of complications or advanced age.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Response rate

Key secondary outcomes

locoregional relapse free survival, survival with primary organ preservation, overall survival, treatment completion rate, incidence and severity of adverse events, economic analysis

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Docetaxel administration group:
Administration of 5 courses (5 weeks) concurrent chemotherapy in which one course consists of docetaxel 12mg/m2 weekly. A total radiation dose of 70 Gy is planned with conventional fractionation (1.8-2Gy/day).
After a total dose of 40 Gy, all patients were clinically evaluated by endoscopy, and by computed tomography scan or magnetic resonance image. Patients with a 50% or greater decrease in the product of 2 perpendicular diameters of primary and neck tumors (responders) continued chemotherapy and completed radiotherapy. For non-responders with resectable tumor, definitive surgery was recommended. 4-6 weeks after the end of treatment, tumor evaluation will be carried out by biopsy, aspiration cytology, and image. If remaining cancer cells is detected in the patient, the patient have a operation.

Interventions/Control_2

S-1 administration group:
Administration of 2 courses (6 weeks) concurrent chemotherapy in which one course consists of S-1 65mg/m2 for 2 weeks administration followed by 1 week rest.
A total radiation dose of 70 Gy is planned with conventional fractionation (1.8-2Gy/day).
After a total dose of 40 Gy, all patients were clinically evaluated by endoscopy, and by computed tomography scan or magnetic resonance image. Patients with a 50% or greater decrease in the product of 2 perpendicular diameters of primary and neck tumors (responders) continued chemotherapy and completed radiotherapy. For non-responders with resectable tumor, definitive surgery was recommended. 4-6 weeks after the end of treatment, tumor evaluation will be carried out by biopsy, aspiration cytology, and image. If remaining cancer cells is detected in the patient, the patient have a operation.

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

85

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)histologically or cytologically confirmed squamous cell carcinoma
2)stage 3 or 4 with no evidence of distant metastases
3)resectable squamous cell carcinoma
4)measurable or assessable region
5)Eastern Cooperative Oncology
Group (ECOG) performance status (PS) of 0 or 1
6)age of 20-85 years
7)sufficient function of important organs
a) WBC: >=4,000/mm3 and <12,000/mm3
b) Neutrophyl: >=2,000/ mm3
c) Platelet: >=100,000/ mm3
d) Hemoglobin: >=11.0 g/dl
e) AST, ALT: 2.0 times of normal range in each institute
f) sT.bil: 1.5 times of normal range in each institute
g) ALP: 2 times of normal range of each institute
h) sCreatinin: <=1.5 mg/dl
l) Ccr: >30ml/min
8)expected more than 3 months survival from drug administration
9)written informed consent

Key exclusion criteria

1)with sever complications (for example ; malignant hypertension, congested heart failure, coronary insufficiency, myocardial infarction, angina pectoris, or abnormal cardiac rhythm which need to treat within 6 months, cerebrovascular accident within 6 months, cirrhosis, hemorrhagic gastrointestinal ulceration, diabetes that is loss of control, bleeding tendency)
2)with deverop fever and suspected infection
3)with motor palsy, peripheral neuropathy or edema (exclude the disorder which derives from primary disease)
4)with pleural effusion which need to treat or pericardial effusions
5)with active double cancer
6)pregnant or nursing women or women who like be pregnant
7)with interstitial pneumonitis which is revealed from chest X ray or chest CT
8)with a history of mental disorder or treated it at the moment
9)with sever allergy to docetaxel or S-1, or with a history of sever allergy
10)doctor's decision not to be registered to this study

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Takahide Taguchi

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Biology and Function in the Head and Neck

Zip code

Address

3-9, Fukuura, Kanazawa-ku, Yokohama,236-0004

TEL

045-787-2687

Email

ttaguchi@yokohama-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Takahide Taguchi

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Biology and Function in the Head and Neck

Zip code

Address

3-9, Fukuura, Kanazawa-ku, Yokohama,236-0004

TEL

045-787-2687

Homepage URL

Email

ttaguchi@yokohama-cu.ac.jp

Institute

study group of chemoradiotherapy of the head and neck cancer

Institute

Department

Personal name

Organization

study group of chemoradiotherapy of the head and neck cancer

Organization

Division

Category of Funding Organization

Self funding

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

横浜市立大学附属病院（神奈川県）

Date of disclosure of the study information

2008

Year

05

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

Terminated

Date of protocol fixation

2007

Year

08

Month

01

Day

Date of IRB

Anticipated trial start date

2008

Year

04

Month

01

Day

Last follow-up date

2012

Year

09

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

05

Month

01

Day

Last modified on

2015

Year

01

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001388