UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I trial of definitive chemoradiotherapy with paclitaxel, cisplatin, and 5-FU (PCF-RT) for esophageal cancer
Title of the study (Brief title)	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	Kei Muro
Organization	Aichi Cancer Center Hospital
Division name	Department of Clinical Oncology
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	Motoo Nomura
Organization	Kyoto university
Division name	Department of Therapeutic Oncology
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
Institute	Aichi Cancer Center Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017370