UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031437
Receipt number R000035893
Scientific Title a phase II study of chemotadiotherapy for 80 or more year-old patients with esophageal cancer
Date of disclosure of the study information 2018/03/01
Last modified on 2024/02/28 17:05:48

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Basic information

Public title

a phase II study of chemotadiotherapy for 80 or more year-old patients with esophageal cancer

Acronym

a phase II study of chemotadiotherapy for elder patients with esophageal cancer

Scientific Title

a phase II study of chemotadiotherapy for 80 or more year-old patients with esophageal cancer

Scientific Title:Acronym

a phase II study of chemotadiotherapy for elder patients with esophageal cancer

Region

Japan


Condition

Condition

esophageal cancer

Classification by specialty

Gastroenterology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

to evaluate the efficucy and safe of radiotherapy concomitant with CDGP+5-FU for 80 or more year-old patients with esophageal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

completion rate of chemoradiotherapy

Key secondary outcomes

overall survival rate, progression-free survial rate and toxicities


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

radiotherapy with 60 Gy/ 30fractions
and chemotherapy (CDGP+5-FU)

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

80 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. histologically proved esophageal cancer
2. T1-4, N0-3, M0/1 lym (UICC 2009)
3. 80 or more years old
4. Performance Status(ECOG):0-1
5. without other severe disease

Key exclusion criteria

1. with distant organ metastases
2. with past irradiation history around current tumors
3. with past history of ESD or EMR for esophageal cancer
4. with active other malignancy
5. with severe other disease

Target sample size

34


Research contact person

Name of lead principal investigator

1st name Keiichi
Middle name
Last name Jingu

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Radiuation Oncology

Zip code

980-8574

Address

1-1 Seiryou-chou, Aobaku

TEL

022-717-7312

Email

kjingu-jr@rad.med.tohoku.ac.jp


Public contact

Name of contact person

1st name Keiichi
Middle name
Last name Jingu

Organization

see above

Division name

see above

Zip code

980-8574

Address

see above

TEL

022-717-7312

Homepage URL


Email

kjingu-jr@rad.med.tohoku.ac.jp


Sponsor or person

Institute

Department of Radiation Oncology, Tohoku Univerity Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Radiation Oncology, Tohoku Univerity Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB of Tohoku Univeristy Hospital

Address

1-1 Seiryou-chou, Aobaku, Sendai

Tel

022-717-3964

Email

rinri-2@proj.med.tohoku.ac.jp


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

東北大学病院(宮城県)


Other administrative information

Date of disclosure of the study information

2018 Year 03 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

Open public recruiting

Date of protocol fixation

2018 Year 03 Month 23 Day

Date of IRB

2018 Year 03 Month 20 Day

Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date

2025 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 23 Day

Last modified on

2024 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035893


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name