Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma

Recruiting

• Conditions: Esophageal Squamous Cell Carcinoma; Chemotherapy Effect; DNA Methylation
• Interventions: Drug: Fluoro Uracil

• Registration Number: NCT06490003
• Lead Sponsor: City of Hope Medical Center

Brief Summary

Esophageal cancer remains a disease with a poor prognosis. Chemotherapy is an important part of its treatment, but there are cases in which chemotherapy is ineffective. The investigators aim to develop a model to predict the response to chemotherapy by DNA methylation of preoperative biopsy specimens to identify the chemotherapy ineffective group.

Detailed Description

Esophageal cancer remains a disease with a poor prognosis. In the treatment of esophageal squamous cell carcinoma (ESCC), multidisciplinary treatment including surgery, chemotherapy, and radiation therapy is important. Chemotherapy is an effective treatment for esophageal cancer, but some patients do not respond to it. Non-response to chemotherapy can result in disease progression, loss of patient fitness, and even the opportunity to receive other treatments that might have originally had a therapeutic effect. If there are biomarkers that could indicate the efficacy of chemotherapy before treatment, ineffective patients would be able to change their treatment plan. Patients on preoperative chemotherapy would be able to avoid unnecessary chemotherapy and undergo surgery without the effects of physical weakness and side effects. On the other hand, patients on definitive chemotherapy may choose to intensify their treatment with additional radiation therapy or immunotherapy. The investigators aim to develop a model to predict the response to chemotherapy by DNA methylation of preoperative biopsy specimens to identify the chemotherapy ineffective

Study Timeline

• Study Start: 2004-06-01
• Study First Submitted: 2024-06-21
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-03
• Last Update Submitted: 2024-07-03
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-08
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Patients who had histologically confirmed esophageal squamous cell carcinoma.
2. Patients who had undergone chemotherapy.
3. Patients receiving initial chemotherapy
4. Written informed consent following full study information is provided to the patient.

Exclusion Criteria

1. Patients for whom a preoperative biopsy sample cannot be obtained
2. Patients who cannot assess at 2 months later after chemotherapy.
3. Patients with multiple cancers.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chemotherapy response patients.	Fluoro Uracil	Responders according to the response evaluation criteria in solid tumors (RECIST). A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP)
Chemotherapy non-response patients	Fluoro Uracil	Responders according to the response evaluation criteria in solid tumors (RECIST). A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP)

Primary Outcome Measures

Name	Time	Method
Overall response rate(Chemotherapy)	1year	The effect of initial chemotherapy is evaluated by imaging. Response evaluation criteria in solid tumors (RECIST) is used for treatment efficacy.

Trial Locations

Locations (1)

Yamanashi Universiy; 🇯🇵 Chuo, Yamanashi, Japan