Clinical trial NCT02813967: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Esophageal Cancer
Chemoradiation
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 298
Sex: ALL
Minimum age (years): 70
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 5 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 5 years
Other outcomes:
measure: the quality of life
timeFrame: 5 years
measure: the oesophagus-specific quality-of-life
timeFrame: 5 years
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: MING CHEN, PHD
role: STUDY_CHAIR
affiliation: Zhejiang Cancer Hospital
name: XIANGHUI DU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Cancer Hospital
name: youngling JI, MD
role: STUDY_DIRECTOR
affiliation: Huaian first people's hospital
name: weiguo zhu, MD
role: STUDY_DIRECTOR
References:
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.