UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical Phase I / II trial of weekly docetaxel therapy in conjunction with radiation in case of FP therapy refractory cases in esophageal cancer
Title of the study (Brief title)	Clinical Phase I / II trial of weekly docetaxel therapy in conjunction with radiation in case of FP therapy refractory cases in esophageal cancer
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Phase I part: We clarified the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of docetaxel dose of docetaxel in simultaneous radiation combination therapy in patients with refractory / intolerant FP therapy in esophageal cancer and recommended one dose lower than MTD Dose (RD) is taken. Phase II part: For 40 cases (including Phase I), treat with docetaxel recommended dose and evaluate the efficacy and safety of docetaxel therapy combined with radiation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	phase 1 part: DLT expression rate phase 2 part: Response rate
Key secondary outcomes

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	Phase 1 part: The dose of docetaxel is initially set at 10mg /m2/day (level1) and the number of cases is increased and the dose escalation is increased by5mg/m2/day according to the expression status of dose limiting toxicity (DLT) in one cycle. We administered 3 cases at each level, and after 1 cycle of the final case, based on the results of all cases to which said dose was administered, shift to the next level add the number of cases judge the maximum tolerated dose Phase 2 part In phase II, chemoradiotherapy is performed in a new case using the recommended dosage of docetaxel obtained in Phase I part. The safety and effectiveness of the test treatment are judged by periodically conducting an image such as blood test or CT or upper gastrointestinal endoscopy
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) The primary lesion is either cervical or thoracic esophagus (TNM classification). 2) Histopathologically it has been diagnosed as squamous cell carcinoma. 3) FP therapy refractory / intolerance. 4) The age of the registration date is 20 years old to 80 years old. 5) ECOG Performance status is 0 to 2. 6) Organ function is maintained. 7) There is no symptomatic brain metastasis. 8) Patients with a history of operation had esophageal cancer for total esophageal cancer cases in which more than 2 weeks had passed since gastric tube reconstruction 9) Cases in which survival is predicted to be at least 3 months or more from the date of registration 10) Cases in which an examination value within 14 days before registration (not including the registration date) satisfies the following criteria Hemoglobin 8.0 g / dL or more White blood cell 3,000 to 13,000 / mm 3 Neutrophils 1,500 / mm 3 or more Platelets 100,000 / mm 3 or more Total bilirubin 1.5 mg / dL or less AST 100 IU / L or less, provided that it has liver metastasis, up to 5 times the upper limit of the facility reference value is allowed ALT 100 IU / L or less, provided that it has liver metastasis, up to 5 times the upper limit of the facility reference value is allowed 11) Hospitalization treatment and outpatient treatment are not limited 12) Regarding the participation of this study, consent from the person in writing is obtained.
Key exclusion criteria	1) Patients receiving transfusions, blood products and hematopoietic factor preparations such as G-CSF within 14 days before registration 2) Cases with infections or diseases requiring systemic administration of antibiotics, antifungal agents 3) Cases with complications as shown below Control poor hypertension, diabetes Severe lung disease (interstitial pneumonia, pulmonary fibrosis, advanced emphysema, etc.) Liver failure Gastrointestinal bleeding that requires treatment 4) Patients with marked electrocardiogram abnormality or cases with clinically problematic heart disease Cases with congestive heart failure, symptomatic coronary artery disease, poorly controlled arrhythmia, a history of myocardial infarction that developed within the last 12 months, etc 5) Cases with psychiatric disorder judged by the investigator or test sharing doctor to have acquired consent or adversely affect test performance Control malfunctioning epileptic seizures, central nervous system disorders, etc. 6) Cases with moderate or more ascites (above the pelvic cavity) or with large pleural effusions 7) Cases with brain metastasis or suspected brain metastasis from clinical symptoms 8) Cases with extensive bone metastases 9) Cases with active duplicated cancers 10) HIV antibody positive cases 11) Patients who received treatment with another study drug within 4 weeks before registration of this study or participate in other clinical trials (incidental study of this study "Esophageal cancer chemical radiation by genetic analysis Clinical research on susceptibility of therapy and prediction of side effects "excluding) 12) Cases judged unsuitable as subjects of the examination by the investigator
Target sample size	40

Research contact person
Name of lead principal investigator	Kazumi Hayashi
Organization	The Jikei University school of medicine
Division name	Department of Hematology and Oncology
Address	3-25-8 Nishi-shinbashi minatoku tokyo
TEL	0334331111
Email	ms01-hayashi@jikei.co.jp

Public contact
Name of contact person	Kazumi Hayashi
Organization	The Jikei University school of medicine
Division name	Department of Hematology and Oncology
Address	3-25-8 Nishi-shinbashi minatoku tokyo
TEL	0334331111
Homepage URL
Email	ms01-hayashi@jikei.co.jp

Sponsor
Institute	The Jikei University school of medicine
Institute
Department

Funding Source
Organization	self funding
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	2017 Year 12 Month 27 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 09 Month 11 Day
Anticipated trial start date	2017 Year 09 Month 11 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 12 Month 27 Day
Last modified on	2017 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034936