UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I Study of definitive chemoradiotherapy with Docetaxel, CDDP and 5-FU for Unresectable or Recurrent Esophageal Cancer
Title of the study (Brief title)	Phase I Study of definitive chemoradiotherapy with Docetaxel, CDDP and 5-FU for Unresectable or Recurrent Esophageal Cancer
Region	Japan

Condition
Condition	advanced or recurrence esophageal carcinoma
Classification by specialty	Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To estimate the maximum tolerated dose and the recommended dose of chemoradiotherapy with docetaxel, cisplatin and 5-fluorouracil for advanved or recurrent esophageal carcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	to estimate the mazimum tolerated dose and the recommendeddose
Key secondary outcomes	adverse events, response rate, overall sirvival, progression free survival

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	Patients receive an infusion of docetaxel (50, 60 or 70mg/m2) on days 1, 22 and an infusion of cisplatin (10 mg/m2) plus a continuous infusion of 5-fluorouracil (400 mg/m2/day) on days 1-5 and 22-26. And patients receive 60 Gy/30 fractions of concurrent radiotherapy.
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 confirmed squamous cell carcinoma of esophagus. 2. clinically confirmed T4 tumor and/or M1 LYM or M1 according to the Tumor-Node-Metastasis classification of the UICC, or recurrent esophageal carcinoma after radical esophagectomy 3. There is at least one estimative lesion. 4. Patients have never received chemoradiotherapy or radiotherapy for esophageal cancer. 5. Patients of age =>20 and 75=> at the registration. 6. Performance Status:0-2(ECOG) 7. Sufficient organ functions within two weeks before registration. 1) leukocyte >=4,000/mm3 and <=12,000/mm3 2) platelets >=100,000/mm3 3) hemoglobin >=9.0g/dl (and except from administration of blood transfusion) 4) total bilirubin <=1.5mg/dl 5) AST(GOT)/ALT(GPT): within 2 times the upper limit of normal 6) total bilirubin <=1.5 mg/dl 7) creatinine clearance >=60ml/min (following Cockcroft-Gault calculus 8) SpO2 >= 95%(at room air) 8. Written informed consent. 9. It is expected that patients survive for over 3 months.
Key exclusion criteria	1. Patients have serious complications (heart disease, pulmonary fibrosis, interstitial pneumonia, hemorrhagic tendency and so on) 2. active infection 3. active synchronous malignancy 4. esophagotracheal or esophagobronchial fistulas 5. peripheral neuropathy or edema >= Grade 2 (CTCAE version3) 6. history of serious drug hypersensitivity 7. brain metastasis 8. pregnant or lactation women, or women with the possibility of the pregnancy and men who want let to pregnancy 9. patients who are judged inappropriate for the entry into study by the investigator
Target sample size	18

Research contact person
Name of lead principal investigator	Yuichiro Doki
Organization	Graduate School of Medicine, Osaka University
Division name	Department of Surgery
Address	2-2 Yamadaoka, Suita, Osaka, 565-0871
TEL	06-6879-3251
Email	ydoki@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	Makoto Yamasaki
Organization	Graduate School of Medicine, Osaka University
Division name	Department of Surgery
Address	2-2 Yamadaoka, Suita, Osaka, 565-0871
TEL	0668793251
Homepage URL
Email	myamasaki@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Department of Surgery, Graduate School of Medicine, Osaka University
Institute
Department

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	大阪大学病院(大阪府)、彩都友紘会病院(大阪府）

Other administrative information
Date of disclosure of the study information	2010 Year 05 Month 18 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2009 Year 07 Month 02 Day
Anticipated trial start date	2009 Year 08 Month 01 Day
Last follow-up date	2013 Year 04 Month 01 Day
Date of closure to data entry	2013 Year 04 Month 01 Day
Date trial data considered complete	2013 Year 05 Month 01 Day
Date analysis concluded	2013 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 05 Month 18 Day
Last modified on	2018 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004403