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

NCT06598917 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

DRUG

S-1

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.

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2026-10-30
Completion
2028-10-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06598917 on ClinicalTrials.gov