S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Patients With Esophageal Cancer
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|ClinicalTrials.gov Identifier: NCT02813967|
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : September 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Chemoradiation||Radiation: Radiotherapy 54 Gy Radiation: Radiotherapy 60 Gy Drug: S-1||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||298 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2016|
|Actual Primary Completion Date :||August 2020|
|Actual Study Completion Date :||August 2020|
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
Radiation: Radiotherapy 54 Gy
Radiotherapy was administered in 1.8 Gy fractions 5 times weekly to a total dose of 54 Gy.
S-1 70mg/m2 was administered on days 1-14 and 29-42.
Active Comparator: Radiotherapy 60 Gy
Radiotherapy 60 Gy was administered in 2Gy fractions 5 times weekly.
Radiation: Radiotherapy 60 Gy
Radiotherapy was administered in 2 Gy fractions 5 times weekly to a total dose of 60Gy.
- Overall survival [ Time Frame: 5 years ]2-year over survival
- Progression-free survival [ Time Frame: 5 years ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 5 years ]
- the quality of life [ Time Frame: 5 years ]assessed with the European Organisation for Research and Treatment of Cancer quality-of-life core questionnaire QLQ-C30
- the oesophagus-specific quality-of-life [ Time Frame: 5 years ]assessed with the European Organisation for Research and Treatment of Cancer quality-of-life the oesophagus-specific questionnaire QLQ-OES18
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813967
|Zhejiang Cancer Hospital|
|Hangzhou, Zhejiang, China, 310022|
|Study Chair:||MING CHEN, PHD||Zhejiang Cancer Hospital|
|Principal Investigator:||XIANGHUI DU, MD||Zhejiang Cancer Hospital|
|Study Director:||youngling JI, MD||Zhejiang Cancer Hospital|
|Study Director:||weiguo zhu, MD||Huaian first people's hospital|