Maintenance Chemotherapy With S-1, Locally Advanced Esophageal Cancer Receiving Definitive CCRT

NCT06598917 | Not Yet Recruiting Phase 2

• 1 other identifier: CMUH113-REC3-106 CHEERS
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Phase II study of definitive concurrent chemoradiotherapy follows consolidative chemotherapy with S1 for locally advanced unresectable esophageal cancer. Our treatment strategy is to perform maintenance chemotherapy with S-1 in patients with locally advanced esophageal cancer receiving dCCRT. The aim of this study is to evaluate the efficacy and side effects of patients with locally advanced unresectable esophageal cancer after dCCRT with platinum-based chemotherapy follow maintenance therapy with S-1. The primary endpoint is overall survival (OS) rates at 24 months, defined as the proportion of patients who have not experienced death from any cause at months. With a sample size of 60 patients, the study had a power of 80%, assuming 2-year OS of 45% in the experimental arm and 30% in the historical control, with a one-sided significance level of 5%.

Conditions

Locally Advanced Unresectable Esophageal Cancer

Keywords

consolidative chemotherapy; esophageal squamous cell carcinoma; S1

Outcome Measures

Primary Outcomes (1)

• overall survival (OS)

  24 months

Study Arms (1)

Maintenance chemotherapy with S-1 regimen

EXPERIMENTAL

Maintenance chemotherapy with S-1 regimen

Drug: S-1

Interventions

S-1 DRUG

Treatment schedule At 4 to 8 weeks after chemotherapy and radiotherapy ended, maintenance S-1 was administered for up to 12 cycles. A cycle was 3 weeks, with S-1 administrated on days 1 to 14 in each cycle. The initial dose of S-1 was determined according to the body surface area (BSA): 40 mg twice a day for BSA \< 1.25 m2; 50 mg twice a day for 1.25 m2⩽ BSA \< 1.5 m2; and 60 mg twice a day for BSA ⩾1.5 m2. Maintenance chemotherapy with S1 was administered for 12 cycles or terminated earlier if there was disease progression, intolerable toxicity, or at the patient's request.

Maintenance chemotherapy with S-1 regimen

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• an age of at least 20 years;
• patients with histologically confirmed diagnosis of ESCC (Esophageal squamous cell carcinoma), GEJC (gastroesophageal junction cancer), EAC (Esophageal adenocarcinoma)
• stage II-IVA, AJCC, 8th, locally advanced disease is suitable for dCCRT and is ineligible for curative surgery (including those who are unable or unwilling to undergo surgery)
• an Eastern Cooperative Oncology Group performance-status score of 0-1
• definitive concurrent chemoradiotherapy according to regional oncology guidelines for esophageal cancer, with the following criteria:
• patients must have received platinum-based chemotherapy (at least 2 cycles of tri-weekly regimen or at least 4 cycles of weekly regimen) and radiation therapy consistent with definitive treatment (50-64 Gy)
• no evidence of radiographic disease progression per RECIST v1.1, as documented by comparison of scans (pre- and post-definitive concurrent chemoradiotherapy) prior to enrollment.
• adequate bone marrow, hepatic, renal and cardiac function

You may not qualify if:

• patients had distant metastasis
• patients had esophageal perforation or esophageal fistula
• patients had tumor bleeding
• patients had severe infection
• History of malignancy other than esophageal cancer within 2 years prior to screening

Sponsors & Collaborators

• China Medical University Hospital: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Ming-Yu LIen, M.D. Ph.D.

CONTACT

8864+22052121; leinmirain@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D Ph.D

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share