S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Patients With Esophageal Cancer

Phase 3

Completed

• Conditions: Esophageal Cancer; Chemoradiation
• Interventions: Radiation: Radiotherapy 54 Gy; Radiation: Radiotherapy 60 Gy; Drug: S-1

• Registration Number: NCT02813967
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

This was a randomised, multicenter, phase 3 trial. Patients who were age of 70 years or older with histologically confirmed esophageal cancer were randomly assigned to S-1 concurrent with radiotherapy or radiotherapy alone.The primary endpoint was overall survival.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-27
• Primary Completion: 2020-08
• Study Completion: 2020-08
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-13
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 298

Inclusion Criteria

• Histological or cytologic diagnosis of esophageal carcinoma
• ECOG performance status 0-1
• Age:70-85 years
• Joined the study voluntarily and signed informed consent form
• Patients must not have received any prior anticancer therapy
• Stage Ⅰ-ⅣB（AJCC 2009）
• Target lesions can be measured according to RECIST criteria
• No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN

Exclusion Criteria

• Multiple carcinomas of the esophagus,
• Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula,
• Metastatic disease (M1b),
• A primary tumor that extended to within 2 cm of the gastroesophageal junction,
• Prior chemotherapy, prior thoracic radiation, surgical resection of the primary tumor,
• history of a second malignancy other than nonmelanoma skin cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chemoradiotherapy	Radiotherapy 54 Gy	Radiotherapy 54 Gy was administered in 1.8 Gy fractions 5 times weekly. S-1 70mg/m2 was administered on days 1-14 and 29-42
Radiotherapy 60 Gy	Radiotherapy 60 Gy	Radiotherapy 60 Gy was administered in 2Gy fractions 5 times weekly.
chemoradiotherapy	S-1	Radiotherapy 54 Gy was administered in 1.8 Gy fractions 5 times weekly. S-1 70mg/m2 was administered on days 1-14 and 29-42

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years	2-year over survival

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	5 years
Progression-free survival	5 years

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China