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

NCT02813967 | Completed Phase 3 DMC

• 1 other identifier: ZJCH-E-E
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Chemoradiation

Outcome Measures

Primary Outcomes (1)

• Overall survival

  2-year over survival

  5 years

Secondary Outcomes (2)

• Progression-free survival

  5 years

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  5 years

Other Outcomes (2)

• the quality of life

  5 years

• the oesophagus-specific quality-of-life

  5 years

Study Arms (2)

chemoradiotherapy

EXPERIMENTAL

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; Drug: S-1

Radiotherapy 60 Gy

ACTIVE COMPARATOR

Radiotherapy 60 Gy was administered in 2Gy fractions 5 times weekly.

Radiation: Radiotherapy 60 Gy

Interventions

Radiotherapy 54 Gy RADIATION

Radiotherapy was administered in 1.8 Gy fractions 5 times weekly to a total dose of 54 Gy.

chemoradiotherapy

Radiotherapy 60 Gy RADIATION

Radiotherapy was administered in 2 Gy fractions 5 times weekly to a total dose of 60Gy.

Radiotherapy 60 Gy

S-1 DRUG

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

chemoradiotherapy

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (1)

• 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.

  PMID: 34351356 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

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

Study Officials

• MING CHEN, PHD

  Zhejiang Cancer Hospital

  STUDY CHAIR

• XIANGHUI DU, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

• youngling JI, MD

  Zhejiang Cancer Hospital

  STUDY DIRECTOR

• weiguo zhu, MD

  Huaian first people's hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 27, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)