Unique ID issued by UMIN | UMIN000016535 |
---|---|
Receipt number | 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 09:50:30 |
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
The study of the significance of p53 Ser46-P in the prediction of response to preoperative treatment for advanced esophageal cancer
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
The study of the significance of p53 Ser46-P in the prediction of response to preoperative treatment for advanced esophageal cancer
Japan |
Advanced esophageal squamous cell carcinoma which are scheduled to undergo chwemotherapy or chemoradiotherapy as an initial treatment
Gastrointestinal surgery |
Malignancy
NO
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.
Safety,Efficacy
Exploratory
Pragmatic
Phase I,II
the correlation between the phosphorylation of P53 Ser-46 and complete response to therapy
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Maneuver |
Tumor tissue is taken by biopsy with endoscopy within the first day and the third day of preoperative chemotherapy or chemoradiotherapy.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
30
1st name | |
Middle name | |
Last name | Takushi Yasuda |
Kindai University, Faculty of Medicine
Department of Surgery
377-2, Ohno-Higashi, Osaka-Sayama, Osaka
072-366-0221
tyasuda@surg.med.kindai.ac.jp
1st name | |
Middle name | |
Last name | Takushi Yasuda |
Kindai University, Faculty of Medicine
Department of Surgery
377-2, Ohno-Higashi, Osaka-Sayama, Osaka
072-366-0221
http://www.kindai-geka.jp/
tyasuda@surg.med.kindai.ac.jp
Kindai University, Faculty of Medicine, Department of Surgery
Japan Society for the Promotion of Science
Japanese Governmental office
NO
近畿大学医学部附属病院(大阪府)
2015 | Year | 02 | Month | 13 | Day |
Unpublished
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.
Completed
2014 | Year | 09 | Month | 10 | Day |
2015 | Year | 02 | Month | 13 | Day |
2016 | Year | 03 | Month | 31 | Day |
2017 | Year | 01 | Month | 30 | Day |
2015 | Year | 02 | Month | 13 | Day |
2017 | Year | 02 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019011