NCT06598917Not yet recruitingPhase 2
Maintenance Chemotherapy With S-1, Locally Advanced Esophageal Cancer Receiving Definitive CCRT
Phase II Study of Maintenance Chemotherapy With S-1 in Patients With Locally Advanced Esophageal Cancer Receiving Definitive Concurrent Chemoradiotherapy
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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%.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 12 Sept 2024
- Start date
- 1 Oct 2024
- Primary completion date
- 30 Oct 2026
- Lead sponsor
- China Medical University Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06598917
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 1 Oct 2024 to the primary completion date, 30 Oct 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- patients had distant metastasis
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.