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

Esophageal Cancer Clinical Trial

Official title:

S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Chinese Patients With Squamous Cell Carcinoma of Esophagus: A Prospective, Randomized, Multi-center Phase-III Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813967
• Other study ID #: ZJCH-E-E
• Status: Completed
• Phase: Phase 3
• Start date: June 2016
• Est. completion date: August 2020

Study information

• Verified date: September 2020
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 85 Years

Eligibility

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 ?-?B(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

Related Conditions & MeSH terms

• Chemoradiation
• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Radiation:
• Radiotherapy 54 Gy
Radiotherapy was administered in 1.8 Gy fractions 5 times weekly to a total dose of 54 Gy.
• Radiotherapy 60 Gy
Radiotherapy was administered in 2 Gy fractions 5 times weekly to a total dose of 60Gy.

Drug:
• S-1
S-1 70mg/m2 was administered on days 1-14 and 29-42.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the quality of life	assessed with the European Organisation for Research and Treatment of Cancer quality-of-life core questionnaire QLQ-C30	5 years
Other	the oesophagus-specific quality-of-life	assessed with the European Organisation for Research and Treatment of Cancer quality-of-life the oesophagus-specific questionnaire QLQ-OES18	5 years
Primary	Overall survival	2-year over survival	5 years
Secondary	Progression-free survival		5 years
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		5 years