UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of definitive chemoradiotherapy with paclitaxel, CDDP and 5-FU (PCF-RT) for clinical stage IA-IIIC esophageal cancer
Title of the study (Brief title)	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	Yamamoto Sachiko
Organization	Osaka international cancer institute
Division name	Gastrointestinal oncology
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	Yamamoto Sachiko
Organization	Osaka international cancer institute
Division name	Gastrointestinal oncology
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
Institute	Osaka international cancer institute
Institute
Department

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

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032500