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 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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016535

Enrollment

Registered

2015-02-13

Start date

2015-02-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced esophageal squamous cell carcinoma which are scheduled to undergo chwemotherapy or chemoradiotherapy as an initial treatment

Interventions

Tumor tissue is taken by biopsy with endoscopy within the first day and the third day of preoperative chemotherapy or chemoradiotherapy.

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
the correlation between the phosphorylation of P53 Ser-46 and complete response to therapy	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactTakushi Yasuda

Kindai University, Faculty of Medicine Department of Surgery

tyasuda@surg.med.kindai.ac.jp072-366-0221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026