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

University of Chinese Academy Sciences

Status and phase: Completed; Phase 3

Conditions: Esophageal Cancer; Chemoradiation

Treatments: Radiation: Radiotherapy 54 Gy; Drug: S-1; Radiation: Radiotherapy 60 Gy

Study type: Interventional

Funder types: Other

Identifiers

NCT02813967

ZJCH-E-E

Details and patient eligibility

About

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.

Enrollment: 298 patients

Sex: All

Ages: 70 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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298 participants in 2 patient groups

chemoradiotherapy

Experimental group

Description:

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

Treatment:

Radiation: Radiotherapy 54 Gy

Drug: S-1

Radiotherapy 60 Gy

Active Comparator group

Description:

Radiotherapy 60 Gy was administered in 2Gy fractions 5 times weekly.

Treatment:

Radiation: Radiotherapy 60 Gy