UMIN-CTR Clinical Trial

Public title

Prospective Study of Concurrent Chemoradiotherapy with S-1 and hypofractionated
radiotherapy for outpatients with early glottic squamous cell carcinomas

Acronym

Prospective Study of Concurrent Chemoradiotherapy with S-1 and hypofractionated
radiotherapy for outpatients with early glottic squamous cell carcinomas

Scientific Title

Prospective Study of Concurrent Chemoradiotherapy with S-1 and hypofractionated
radiotherapy for outpatients with early glottic squamous cell carcinomas

Scientific Title:Acronym

Prospective Study of Concurrent Chemoradiotherapy with S-1 and hypofractionated
radiotherapy for outpatients with early glottic squamous cell carcinomas

Region

Japan

Condition

T1 bulky/T2 favorable Glottic carcinoma, squamous cell carcinoma

Classification by specialty

Oto-rhino-laryngology

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The recommended treatment strategies for early glottis carcinoma (GC) with intent of larynx preservation are mainly radiotherapy (RT), transoral laser therapy and partial laryngonectomy. However, the outcomes of RT alone for T1 bulky or T2 GC are unsatisfactory. We deigned the protocol of chemoradiotherapy (CCRT) using S-1 as the radiosensitizer and we have performed the CCRT with patients with T2 favorable. In our protocol of CCRT with S-1, S-1 was taken orally once daily after breakfast and RT with 2 Gy/ day, five days/ week, to a total of 30 fractions (total dose of 60 Gy). We have showed the efficacy and safety of this protocol. Thus, with the aim of improving the local control rate with primary RT and shortening the treatment period, we changed the dose of radiation in our protocol of CCRT using S-1 from 2 Gy per fraction, a total of 30 fractions, to 2.25 Gy per fraction, a total of 25 fractions. The present study concept is to evaluate the efficacy and safety of the new protocol.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

3-year local control rate

Key secondary outcomes

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

Maneuver

Interventions/Control_1

Treatment schedule: S-1 is taken orally once daily after breakfast and radiotherapy (RT) with 2.25 Gy/day, five days/week, to a total of 25 fractions (total dose of 56.25 Gy), is delivered. Oral S-1 and RT is started on the same day, on Monday in principle, and RT is performed between 3 and 6 hours after oral administration of S-1. S-1 is not administered on Saturdays or Sundays, when RT is not performed. The dose of S-1 is 55.3 mg/m2/day.
Radiotherapy: Conventional RT was performed with 4-MV photons at 2.25 Gy/fraction/day. The total dose delivered is 56.25 Gy/25 fractions over a 5-week period. RT was planned for all patients after appropriate immobilization, with a thermoplastic mask and 3D CT-based techniques. Two parallel-opposed lateral fields are used with a pair of wedge filters. The field size is reduced after administration of 45 Gy according to reduction of the size of tumor.

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) the primary site confirmed at glottis by laryngoscopy in 28 days before enrollment; (2) the T-stage diagnosed as bulky T1 or T2 without impaired cord mobility by laryngoscopy; (3) histologically- or cytologically- confirmed glottic squamous carcinoma; (4) Confirmed as N0M0 by chest X-ray or contrast-enhanced computer tomography; (5) no prior chemotherapy for malignancy within 5 years; (6) aged 20-80 years; (7) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; (8) no prior history of radiotherapy or surgery to the planned irradiation area; (9) willing to participate and sign informed consent; (10) adequate bone marrow, liver, and kidney functions.

Key exclusion criteria

(1) unable to take oral S-1; (2) with a history of severe allergy; (3) severe clinical infection; (4) with active double cancer including simultaneous cancer or metachronous cancer within 5 years, except for in situ or intramucosal carcinoma; (5) being pregnant or breast feeding; (6) with mental disease interfering participating the trial; (7) with severe bone marrow dysfunction; (8) with the history of kidney disease, such as getting dialysis; (9) with the history of severe liver disease; (10)with the history of severe lung disease, such as interstitial pneumonia of pulmonary fibrosis; (11) with the history of collagen disease; (12) with uncontrolled diabetes mellitus or insulin-dependent diabetes mellitus; (13) with uncontrolled hypertension; (14) cardiovascular diseases with clinical significance, such as heart failure, history of myocardial infarction or angina in the past half year; (15) taking drugs as follows; other pyrimidine compound- anticancer drug or flucytosine ; (16) jugged as inadequate case by doctor in charge.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Yoshiyuki Itoh

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Radiology

Zip code

Address

65 Tsurumai-cho, Shouwa-ku, Nagoya, Aichi 466-8550, Japan

TEL

052-744-2328

Email

itoh@med.nagoya-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yoshiyuki Itoh

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Radiology

Zip code

Address

65 Tsurumai-cho, Shouwa-ku, Nagoya, Aichi 466-8550, Japan

TEL

052-744-2328

Homepage URL

Email

itoh@med.nagoya-u.ac.jp

Institute

Nagoya University Graduate School of Medicine, Department of Radiology

Institute

Department

Personal name

Organization

Nagoya 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

2016

Year

08

Month

31

Day

URL releasing protocol

Publication of results

Partially published

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

Preinitiation

Date of protocol fixation

2016

Year

08

Month

31

Day

Date of IRB

Anticipated trial start date

2016

Year

09

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

07

Month

31

Day

Last modified on

2016

Year

09

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026930