Maintenance Chemotherapy With S-1, Locally Advanced Esophageal Cancer Receiving Definitive CCRT
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorChina Medical University Hospital
About this trial
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%.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
patients had distant metastasis
patients had esophageal perforation or esophageal fistula
patients had tumor bleeding
patients had severe infection
Trial design
Design model
Single group
Treatments tested in this trial
S-1
DrugTreatment 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Maintenance chemotherapy with S-1 regimenExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
overall survival (OS)
Time frame
24 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: