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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

Phase 1
Conditions
Advanced esophageal squamous cell carcinoma which are scheduled to undergo chwemotherapy or chemoradiotherapy as an initial treatment
Registration Number
JPRN-UMIN000016535
Lead Sponsor
Kindai University, Faculty of Medicine, Department of Surgery
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
the correlation between the phosphorylation of P53 Ser-46 and complete response to therapy
Secondary Outcome Measures
NameTimeMethod
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
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