Back to resultsS-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Patients With Esophageal Cancer
Primary Purpose
Esophageal Cancer, Chemoradiation
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Radiotherapy 54 Gy
Radiotherapy 60 Gy
S-1
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer
Eligibility Criteria
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
Sites / Locations
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
chemoradiotherapy
Radiotherapy 60 Gy
Arm 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
Radiotherapy 60 Gy was administered in 2Gy fractions 5 times weekly.
Outcomes
Primary Outcome Measures
Overall survival
2-year over survival
Secondary Outcome Measures
Progression-free survival
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Full Information
NCT ID
NCT02813967
First Posted
June 14, 2016
Last Updated
September 13, 2020
Sponsor
Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02813967
Brief Title
S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Patients With Esophageal Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 2020 (Actual)
Study Completion Date
August 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Chemoradiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
298 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chemoradiotherapy
Arm Type
Experimental
Arm 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
Arm Title
Radiotherapy 60 Gy
Arm Type
Active Comparator
Arm Description
Radiotherapy 60 Gy was administered in 2Gy fractions 5 times weekly.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy 54 Gy
Intervention Description
Radiotherapy was administered in 1.8 Gy fractions 5 times weekly to a total dose of 54 Gy.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy 60 Gy
Intervention Description
Radiotherapy was administered in 2 Gy fractions 5 times weekly to a total dose of 60Gy.
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
S-1 70mg/m2 was administered on days 1-14 and 29-42.
Primary Outcome Measure Information:
Title
Overall survival
Description
2-year over survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
5 years
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
the quality of life
Description
assessed with the European Organisation for Research and Treatment of Cancer quality-of-life core questionnaire QLQ-C30
Time Frame
5 years
Title
the oesophagus-specific quality-of-life
Description
assessed with the European Organisation for Research and Treatment of Cancer quality-of-life the oesophagus-specific questionnaire QLQ-OES18
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MING CHEN, PHD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
XIANGHUI DU, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
youngling JI, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
weiguo zhu, MD
Organizational Affiliation
Huaian first people's hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34351356
Citation
Ji Y, Du X, Zhu W, Yang Y, Ma J, Zhang L, Li J, Tao H, Xia J, Yang H, Huang J, Bao Y, Du D, Liu D, Wang X, Li C, Yang X, Zeng M, Liu Z, Zheng W, Pu J, Chen J, Hu W, Li P, Wang J, Xu Y, Zheng X, Chen J, Wang W, Tao G, Cai J, Zhao J, Zhu J, Jiang M, Yan Y, Xu G, Bu S, Song B, Xie K, Huang S, Zheng Y, Sheng L, Lai X, Chen Y, Cheng L, Hu X, Ji W, Fang M, Kong Y, Yu X, Li H, Li R, Shi L, Shen W, Zhu C, Lv J, Huang R, He H, Chen M. Efficacy of Concurrent Chemoradiotherapy With S-1 vs Radiotherapy Alone for Older Patients With Esophageal Cancer: A Multicenter Randomized Phase 3 Clinical Trial. JAMA Oncol. 2021 Oct 1;7(10):1459-1466. doi: 10.1001/jamaoncol.2021.2705.
Results Reference
derived
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S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Patients With Esophageal Cancer
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