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

• ClinicalTrials.gov Identifier: NCT02813967
• Recruitment Status: Completed
• First Posted: June 27, 2016
• Last Update Posted: September 16, 2020
• Sponsor: Zhejiang Cancer Hospital
• Information provided by (Responsible Party): Zhejiang Cancer Hospital

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.

Condition or disease	Intervention/treatment	Phase
Esophageal Cancer; Chemoradiation	Radiation: Radiotherapy 54 Gy; Radiation: Radiotherapy 60 Gy; Drug: S-1	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 298 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: chemoradiotherapy; 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.; Drug: S-1; 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.

Outcome Measures

Primary Outcome Measures :

1. Overall survival [ Time Frame: 5 years ]
   2-year over survival

Secondary Outcome Measures :

1. Progression-free survival [ Time Frame: 5 years ]
2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 5 years ]

Other Outcome Measures:

1. 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
2. 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

Eligibility Criteria

• Ages Eligible for Study: 70 Years to 85 Years (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

China, Zhejiang

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022

Sponsors and Collaborators

Zhejiang Cancer Hospital

Investigators

• 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Zhejiang Cancer Hospital
• ClinicalTrials.gov Identifier: NCT02813967
• Other Study ID Numbers: ZJCH-E-E
• First Posted: June 27, 2016
• Last Update Posted: September 16, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases