UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015306
Receipt number R000017795
Scientific Title Phase I Dose-Escalation Study of Intensity-modulated Radiation Therapy in Patients with Locally Advanced Unresectable Esophageal Cancer
Date of disclosure of the study information 2014/10/01
Last modified on 2019/04/05 12:44:56

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Basic information

Public title

Phase I Dose-Escalation Study of Intensity-modulated Radiation Therapy in Patients with Locally Advanced Unresectable Esophageal Cancer

Acronym

Phase I Dose-Escalation Study of Intensity-modulated Radiation Therapy in Patients with Locally Advanced Unresectable Esophageal Cancer

Scientific Title

Phase I Dose-Escalation Study of Intensity-modulated Radiation Therapy in Patients with Locally Advanced Unresectable Esophageal Cancer

Scientific Title:Acronym

Phase I Dose-Escalation Study of Intensity-modulated Radiation Therapy in Patients with Locally Advanced Unresectable Esophageal Cancer

Region

Japan


Condition

Condition

Esophageal neoplasm

Classification by specialty

Gastroenterology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To estimate the maximum tolerated dose and to determine the recommended dose of intensity-modulated radiation therapy for locally advanced unresectable thoracic esophageal cancer

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

incidence of (1) Grade 3 or more esophagitis, (2) Grade 2 or more radiation pneumonitis, (3) Grade 2 or more conduction disorder/pericardial effusion/pericarditis/acute coronary syndrome within 90 days after intensity-modulated radiation therapy and (4) more than 60 days of treatment duration to finish a radiation therapy due to adverse events

Key secondary outcomes



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

Chemoradiotherapy consists of 5-FU (700 mg/m2, day 1-4, day 29-32), cisplatin (70 mg/m2, day 1, 29) and intensity-modulated radiation therapy (66-72 Gy/30 fr: 66 Gy/30 fr at level 1, 69 Gy/30 fr at level 2 and 72 Gy/30 fr at level 3), followed by adittional two courses chemotherapy with 5-FU (800 mg/m2, day 1-5) plus cisplatin (80 mg/m2, day 1).

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma located in the thoracic esophagus
2) Clinical stage IIIC or IV with supraclavicular lymph node metastasis
i)Primary tumor invasion depth T4
ii)Metastatic regional lymph node(s) invasion to adjacent organ
3) No esophageal fistula
4) No aortic invasion
5) Aged 20 to 75 years old
6) ECOG Performance status 0 or 1
7) Adequate organ functions
8) Written informed consent

Key exclusion criteria

1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy
2) Active infection requiring systemic therapy
3) Fever over 38 degrees Celsius
4) Pregnant or lactating women or women of childbearing potential
5) Psychosis
6) Patients requiring systemic steroids medication
7) Serum HBs antigen positive
8) Uncontrolled diabetes mellitus
9) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months.
10) Interstitial pneumonia, fibroid lung, or severe emphysema
11) With a history of cerebrovascular disorder within 6 months
12) Connective tissue disease
13) History of radiation therapy to chest
14) History of surgery for esophageal cancer

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiro Hiraoka

Organization

Graduate School of Medicine and Faculty of Medicine Kyoto University

Division name

Department of Radiation Oncology and Image-Applied Therapy

Zip code


Address

54, Sho-goinn, Kawaharacho, Sakyo-ku, Kyoto, Kyoto

TEL

075-751-3419

Email

hiraok@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Katsuyuki Sakanaka

Organization

Graduate School of Medicine and Faculty of Medicine Kyoto University

Division name

Department of Radiation Oncology and Image-Applied Therapy

Zip code


Address

54, Sho-goinn, Kawaharacho, Sakyo-ku, Kyoto, Kyoto

TEL

075-751-3762

Homepage URL


Email

sakanaka@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine and Faculty of Medicine Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

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

2014 Year 10 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

Completed

Date of protocol fixation

2014 Year 09 Month 24 Day

Date of IRB

2014 Year 10 Month 10 Day

Anticipated trial start date

2014 Year 10 Month 10 Day

Last follow-up date

2018 Year 12 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

2014 Year 10 Month 01 Day

Last modified on

2019 Year 04 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017795


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name