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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020397
Receipt No. R000022521
Scientific Title Phase I/II Study of Chemoradiotherapy with Paclitaxel for Elderly Stage IB-III Esophageal Cancer
Date of disclosure of the study information 2016/01/01
Last modified on 2016/05/26

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Basic information
Public title Phase I/II Study of Chemoradiotherapy with Paclitaxel for Elderly Stage IB-III Esophageal Cancer
Acronym Phase I/II Study of Chemoradiotherapy with Paclitaxel for Elderly Esophageal Cancer
Scientific Title Phase I/II Study of Chemoradiotherapy with Paclitaxel for Elderly Stage IB-III Esophageal Cancer
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Yuko Kitagawa
Organization Keio University School of Medicine
Division name Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Email kitagawa@a3.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuo Hamamoto, Kenro Hirata
Organization Keio University School of Medicine
Division name Gastroenterology and Hepatology
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2015 Year 10 Month 16 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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