UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028589
Receipt number R000032500
Scientific Title Phase I study of definitive chemoradiotherapy with paclitaxel, CDDP and 5-FU (PCF-RT) for clinical stage IA-IIIC esophageal cancer
Date of disclosure of the study information 2017/08/08
Last modified on 2017/08/08 19:27:57

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Basic information

Public title

Phase I study of definitive chemoradiotherapy with paclitaxel, CDDP and 5-FU (PCF-RT) for clinical stage IA-IIIC esophageal cancer

Acronym

Phase I study of definitive CRT with PCF (PCF-RT) for clinical stage IA-IIIC esophageal cancer

Scientific Title

Phase I study of definitive chemoradiotherapy with paclitaxel, CDDP and 5-FU (PCF-RT) for clinical stage IA-IIIC esophageal cancer

Scientific Title:Acronym

Phase I study of definitive CRT with PCF (PCF-RT) for clinical stage IA-IIIC esophageal cancer

Region

Japan


Condition

Condition

esophageal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To estimate the maximum tolerated dose (MTD) and the dose limiting toxicity (DLT), and to determine the recommended dose (RD) of definitive chemoradiotherapy with paclitaxel, CDDP and 5-FU for clinical stage IA-IIIC esophageal cancer.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase I


Assessment

Primary outcomes

Incidence of dose limiting toxicity

Key secondary outcomes

Adverse events (AE), complete response rate (CRR), progression-free survival (PFS), overall survival(OS)


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 with paclitaxel, 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, adenosquamous cell carcinoma or basaloid carcinoma of the esophagus
2) Primary lesion are located within the cervical esophagus (Ce) and the abdominal esophagus (Ae)
3) Aged 20 to 80 years old
4) ECOG PS of 0 or 1
5) Clinical stage IA-IIIC (UICC-TNM ver.7.0)
6) No need for measurable lesion
7) No previous treatment of esophageal cancer except EMR or ESD
8) No palsy of recurrent nerve
9) Refused esophagectomy
10) Adequate organ functions
11) Written informed consent

Key exclusion criteria

1) Simultaneous or metachronous double cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer
2) History of radiotherapy for mediastinum
3) Uncontrollable diabetes millutus
4) History of myocardial infarction within 6 months, or unstable angina pectoris or cardiac failure
5) Uncontrollable arrhythmia
6) Patients requiring systemic steroids medication
7) Liver cirrhosis
8) Active bacterial or fungous infection
9) With a history of grade 2-4 allergic reaction by CTCAE version 4.0
10) With grade 2-4 nerve disturbance by CTCAE version 4.0
11) With blood transfusion within 2 weeks and/or active bleeding
12) Interstitial pneumonia, fibroid lung or severe emphysema
13) With a history of allergic reaction to polyoxy-ethilen oil, hydrogenated castor oil or polysorbate 80
14) Psychosis
15) Pregnant or lactating women, women of childbearing potential or men who like to have children in future
16) Any patients judged by the investigator to be unfit to participate in the study

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yamamoto Sachiko

Organization

Osaka international cancer institute

Division name

Gastrointestinal oncology

Zip code


Address

3-1-69, Otemae, Osaka-city, Osaka, 541-8567 Japan

TEL

06-6945-1181

Email

yamamoto-sa@mc.pref.osaka.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yamamoto Sachiko

Organization

Osaka international cancer institute

Division name

Gastrointestinal oncology

Zip code


Address

3-1-69, Otemae, Osaka-city, Osaka, 541-8567 Japan

TEL

06-6945-1181

Homepage URL


Email

yamamoto-sa@mc.pref.osaka.jp


Sponsor or person

Institute

Osaka international cancer institute

Institute

Department

Personal name



Funding Source

Organization

Osaka international cancer institute

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


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

大阪国際がんセンター(大阪府)


Other administrative information

Date of disclosure of the study information

2017 Year 08 Month 08 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

Preinitiation

Date of protocol fixation

2017 Year 07 Month 12 Day

Date of IRB


Anticipated trial start date

2017 Year 07 Month 26 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

2017 Year 08 Month 08 Day

Last modified on

2017 Year 08 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032500


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name