UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II Study of Chemoradiotherapy with Paclitaxel for Elderly Stage IB-III Esophageal Cancer
Title of the study (Brief title)	Phase I/II Study of Chemoradiotherapy with Paclitaxel for Elderly Esophageal Cancer
Region	Japan

Condition
Condition	Esophageal Cancer
Classification by specialty	Medicine in general Gastroenterology Geriatrics Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	<Phase I> To determine the recommended dose of Paclitaxel for elderly Stage IB-III esophageal cancer patients in chemoradiotherapy with Paclitaxel. <Phase II> To evaluate safety and efficacy of the recommended dose of chemoradiotherapy with Paclitaxel in elderly Stage IB-III esophageal cancer patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	<Phase I> The frequency of DLT (Dose Limiting Toxicity) <Phase II> Two year survival rate
Key secondary outcomes	<Phase I> Adverse event, Overall survival, Progression-free survival, Complete response rate, Pharmacokinetics, Geriatric Assessment <Phase II> Complete response rate, Progression-free survival, Adverse event, Late toxicity, Pharmacokinetics, Geriatric Assessment

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 Other
Interventions/Control_1	Paclitaxel 30-60mg/m2 (day1, 8, 15, 22, 29, 36) or 40-60mg/m2 (day1, 15, 29) Radiation 60Gy/30fr
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma or basaloid cell carcinoma. 2) Primary tumor located in thoracic esophagus. Second tumors in cervical or abdominal esophagus which is indicated for EMR/ESD are also eligible. 3) Clinical stages IB, II or III (excluding T4) based on the 7th UICC-TNM classification. 4) Patients who are amenable to 60Gy radiation therapy. 5) >=70 years old. 6) i) >=70 and <80 year-old-patient, PS (ECOG) of 0 or 1, and Creatinine>=1.5mg/dl. ii) >=70 and <80 year-old-patient, PS (ECOG) of 2. iii) >=80 year-old-patient, PS (ECOG) of 0 and 1. 7) Patients have measurable and/or non-measurable disease according to RECIST ver1.1. 8) No prior treatment against esophageal cancer except for endoscopic resection. 9) No prior chemotherapy and radiation therapy. 10) Sufficient organ functions. i) Neutrophil >= 1500/mm3 ii) WBC < 12000/mm3 iii) Platelet >= 100000/mm3 iv) T.Bil =< 1.5mg/dL v) AST =< 100IU/L vi) ALT =< 100IU/L 11) refused esophagectomy. 12) Written informed consent.
Key exclusion criteria	1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2) Infectious disease with systemic therapy indicated. 3) Severe psychiatric disease. 4) Continuous systemic steroid therapy. 5) Poorly controlled diabetes mellitus. 6) Severe pulmonary fibrosis or emphysema. 7) Unstable angina pectoris, or history of myocardial infarction within three months. 8) Other conditions not suitable for this study.
Target sample size	74

Research contact person
Name of lead principal investigator	Yuko Kitagawa
Organization	Keio University School of Medicine
Division name	Surgery
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email	kitagawa@a3.keio.jp

Public contact
Name of contact person	Yasuo Hamamoto, Kenro Hirata
Organization	Keio University School of Medicine
Division name	Gastroenterology and Hepatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	kenro916@gmail.com

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2016 Year 01 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 10 Month 16 Day
Anticipated trial start date	2016 Year 04 Month 21 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	2015 Year 12 Month 29 Day
Last modified on	2016 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022521