UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014927
Receipt number R000017370
Scientific Title Phase I trial of definitive chemoradiotherapy with paclitaxel, cisplatin, and 5-FU (PCF-RT) for esophageal cancer
Date of disclosure of the study information 2014/08/22
Last modified on 2017/08/24 14:53:24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Phase I trial of definitive chemoradiotherapy with paclitaxel, cisplatin, and 5-FU (PCF-RT) for esophageal cancer

Acronym

Phase I trial of definitive chemoradiotherapy with paclitaxel, cisplatin, and 5-FU (PCF-RT) for esophageal cancer

Scientific Title

Phase I trial of definitive chemoradiotherapy with paclitaxel, cisplatin, and 5-FU (PCF-RT) for esophageal cancer

Scientific Title:Acronym

Phase I trial of definitive chemoradiotherapy with paclitaxel, cisplatin, and 5-FU (PCF-RT) for esophageal cancer

Region

Japan


Condition

Condition

esophageal cancer

Classification by specialty

Gastroenterology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

safety

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Incidence of dose limiting toxicity

Key secondary outcomes

Adverse events, overall survival, progression free survival, response rate, complete response rate


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 Maneuver

Interventions/Control_1

Current chemoradiotherapy with PTX, CDDP, and 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

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Histologically proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma or basal cell carcinoma of the esophagus
2) Primary lesion are located within the thoracic esophagus (Te)
3) Clinical stage I or II or III or IV (with supraclavicular LN)
4) Total radiation dose is 50.4Gy
5) Aged 20 to 75 years old
6) ECOG PS of 0 or1
7) no need for measurable lesion
8) no previous treatment of esophageal cancer except EMR or ESD
9) no previous chemotherapy or radiotherapy against any other malignancies
10) adequate organ functions
11) refused esophagectomy
12) written informed consent

Key exclusion criteria

1) Histologically proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma or basal cell carcinoma of the esophagus
2) Primary lesion are located within the thoracic esophagus (Te)
3) Clinical stage I or II or III or IV (with supraclavicular LN)
4) Total radiation dose is 50.4Gy
5) Aged 20 to 75 years old
6) ECOG PS of 0 or1
7) no need for measurable lesion
8) no previous treatment of esophageal cancer except EMR or ESD
9) no previous chemotherapy or radiotherapy against any other malignancies
10) adequate organ functions
11) refused esophagectomy
12) written informed consent

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kei Muro

Organization

Aichi Cancer Center Hospital

Division name

Department of Clinical Oncology

Zip code


Address

1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.

TEL

052-762-6111

Email

kmuro@aichi-cc.jp


Public contact

Name of contact person

1st name
Middle name
Last name Motoo Nomura

Organization

Kyoto university

Division name

Department of Therapeutic Oncology

Zip code


Address

54 Shogoin Kawahara-cho Sakyo-ku Kyoto 606-8507 Japan

TEL

075-751-3518

Homepage URL


Email

mnomura@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Aichi Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

Aichi Cancer Center Hospital

Organization

Division

Category of Funding Organization

Other

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 08 Month 22 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 06 Month 12 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 22 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 08 Month 22 Day

Last modified on

2017 Year 08 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017370


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name