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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016535
Receipt No. R000019011
Scientific Title The study of the significance of the phosphorylation of p53 Ser46 in the prediction of response to preoperative chemotherapy or chemoradiotherapy for advanced esophageal cancer
Date of disclosure of the study information 2015/02/13
Last modified on 2017/02/14

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Basic information
Public title The study of the significance of the phosphorylation of p53 Ser46 in the prediction of response to preoperative chemotherapy or chemoradiotherapy for advanced esophageal cancer
Acronym The study of the significance of p53 Ser46-P in the prediction of response to preoperative treatment for advanced esophageal cancer
Scientific Title The study of the significance of the phosphorylation of p53 Ser46 in the prediction of response to preoperative chemotherapy or chemoradiotherapy for advanced esophageal cancer
Scientific Title:Acronym The study of the significance of p53 Ser46-P in the prediction of response to preoperative treatment for advanced esophageal cancer
Region
Japan

Condition
Condition Advanced esophageal squamous cell carcinoma which are scheduled to undergo chwemotherapy or chemoradiotherapy as an initial treatment
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Advanced esophageal cancer is recently treated by multimodality therapy, therefore, it is an urgent issue to establish a therapy for individual based on the prediction of treatment response. The researches conducted so far revealed that mutant P53 has a close association with poor or no response to therapy. However, patinets with wild-type P53 did not always show good response, speculating that the phosphorylation of P53 Ser-46, which is the active form of P53 inducing apoptosis, is likely to be required. Consequently, the first step of this study is aimed to investigate the usefulness of phosphorylation of P53 Ser-46 as a prediction factor of treatment response. Next, the second step of this study is designed to improve the indivsualized therapy on the treatment outcome and QOL on the basis of the P53 genotype and the induction of phosphorylation of P53 Ser-46.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes the correlation between the phosphorylation of P53 Ser-46 and complete response to therapy
Key secondary outcomes 1. the correlation between the phosphorylation of P53 Ser-46 and clinical good response (CR and PR)
2. the correlation between the phosphorylation of P53 Ser-46 and histological complete response
3. the correlation between the phosphorylation of P53 Ser-46 and P53 genotype
4. the correlation between the phosphorylation of P53 Ser-46 and the prognosis
5. the correlation between the phosphorylation of P53 Ser-46 and failure patterns
6. the comparison of P53 status in pretreatment tumor and residual or local recurrent tumor after treatment

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 Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Tumor tissue is taken by biopsy with endoscopy within the first day and the third day of preoperative chemotherapy or chemoradiotherapy.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. histologically confirmed esophageal squamous cell carcinoma.
2. M0, however, M1LYM of the supraclavicular lymph nodes is eligble.
3. no history of chemotherapy or radiotherapy.
4. irrespective of whether or not tumor can be resected.
5. at age 20 years or over.
6. performance status of 0 or 1.
7. good function of main organs.
8. meet the criteria of laboratory data before enrollment. WBC 3,000 or more and less than 12,000/mm3
Neutrophil 1,500/mm3 or more
Platelet 100,000/mm3 or more
Hb 9g/dl or more
Total bilirubin 1.2mg/dl or less
AST and ALT within 2 times of the
normal upper limit of the institution
9. cleatinine clearance 60ml/min or more
10. SpO2 95% or more in room air
11. Written informed consent is obtained.
Key exclusion criteria 1. another malignat disease to need treatment
2. past hostory of severe drug hypersensitivity
3. pregnant female, nursing mother and women who have childbearing potential and are considering pregnancy.
4. doctor rules unfit for enrollment of this study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takushi Yasuda
Organization Kindai University, Faculty of Medicine
Division name Department of Surgery
Zip code
Address 377-2, Ohno-Higashi, Osaka-Sayama, Osaka
TEL 072-366-0221
Email tyasuda@surg.med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takushi Yasuda
Organization Kindai University, Faculty of Medicine
Division name Department of Surgery
Zip code
Address 377-2, Ohno-Higashi, Osaka-Sayama, Osaka
TEL 072-366-0221
Homepage URL http://www.kindai-geka.jp/
Email tyasuda@surg.med.kindai.ac.jp

Sponsor
Institute Kindai University, Faculty of Medicine, Department of Surgery
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
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 近畿大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 13 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 In this study, we examined the usefulness of induction of the phosphorylation of p53-Ser46 the next day after initiation of treatment as a biomarker of the prediction of treatment response of chemotherapy/chemoradiotherapy for esophageal squamous cell carcinoma. We confirmed the fact for the first time that the phosphorylation of p53-Ser-46 was induced by chemotherapy/chemoradiotherapy in the early stage of treatment. However, there was no significant correlation between the phosphorylation of p-53-Ser-46 and treatment response. Among cases obtained complete response to preoperative therapy, the cases with p-53 mutant and no induction of Ser-46 phosphorylation were involved, therefore, these results suggested that the effect on chemotherapy and chemoradiotherapy was caused not only by apoptosis thorough p53 pathway, but also by another pathway associating with other factors.
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 Completed
Date of protocol fixation
2014 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2017 Year 01 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 02 Month 13 Day
Last modified on
2017 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019011

Research Plan
Registered date File name
2017/02/14 実施計画書.docx

Research case data specifications
Registered date File name
2017/02/14 実施計画書.docx

Research case data
Registered date File name


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