UMIN-CTR Clinical Trial

Public title

Clinical trial of concurrent chemoradiotherapy (CCRT) with S-1 in patients with advanced head and neck squamous cell carcinoma, who is not eligible for CCRT with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) regimen

Acronym

Clinical trial of concurrent chemoradiotherapy with S-1 in patients with advanced head and neck squamous cell carcinoma

Scientific Title

Clinical trial of concurrent chemoradiotherapy (CCRT) with S-1 in patients with advanced head and neck squamous cell carcinoma, who is not eligible for CCRT with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) regimen

Scientific Title:Acronym

Clinical trial of concurrent chemoradiotherapy with S-1 in patients with advanced head and neck squamous cell carcinoma

Region

Japan

Condition

advanced head and neck squamous cell carcinoma

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) 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

Trial characteristics_2

Developmental phase

Primary outcomes

Progression free survival rate

Key secondary outcomes

Response rate, treatment completion rate, Cause specific survival rate, Overall survival period, Safety

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

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_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

85

years-old

>

Gender

Male and Female

Key inclusion criteria

1. histologically or cytologically confirmed squamous cell carcinoma
2. Primary lesion located in oropharynx, hypopharynx, or larynx diagnosed as stage III, IVA or IVB with no evidence of distant metastases
3. Age of more than 76 years, or who is note eligible for concurrent chemoradiotherapy with TPF regimen
4. measurable or assessable region
5. previously untreated
6. ECOG performance status are 0 or 1.
7. With adequate major organ functions within 14 days before trial entry, as defined below:
1) White blood cell count >= 3,000/mm3, 12,000/mm3 <
2) Neutrophil count >=2,000/ mm3
3) Platelet count >=100,000/ mm3
4) Hemoglobin >=10.0 g/dl
5) AST, ALT: 2.0 times of normal range in each institute
6) ALP: 2 times of normal range of each institute
7) T.bil: 1.5 times of normal range in each institute
8) serum Creatinine <=1.5 mg/dl
9) creatinine clearance >=30ml/min
8. expected more than 3 months survival from drug administration
9. written informed consent
10. Possible oral intake

Key exclusion criteria

1. with active double cancer
2. 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)
3. with deverop fever and suspected infection
4. with motor palsy, peripheral neuropathy or edema (exclude the disorder which derives from primary disease)
5. with pleural effusion which need to treat or pericardial effusions
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 momen
9. with a history of sever drug allergy
10. with sever allergy to S-1
11. during any treatment with other pyrimidine analogue drug
12. during any treatment with Flucytosine
13. Physician concludes that the patient&#39;s participation in this trial is inappropriate

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Nobuhiko Oridate

Organization

Yokohama City University, school of medicine

Division name

Department of Otolaryngology - Head and Neck Surgery

Zip code

Address

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

TEL

045-787-2800

Email

noridate@yokohama-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Daisuke Sano

Organization

Yokohama City University, school of medicine

Division name

Department of Otolaryngology - Head and Neck Surgery

Zip code

Address

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

TEL

045-787-2800

Homepage URL

Email

dsano@yokohama-cu.ac.jp

Institute

Yokohama City University hospital

Institute

Department

Personal name

Organization

None

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

Date of disclosure of the study information

2016

Year

04

Month

11

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

Open public recruiting

Date of protocol fixation

2016

Year

02

Month

18

Day

Date of IRB

Anticipated trial start date

2016

Year

03

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

04

Month

11

Day

Last modified on

2016

Year

04

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025187