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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813967
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : September 15, 2020
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital

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

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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

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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.




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



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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

Information from the National Library of Medicine

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


Locations
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China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
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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
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Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT02813967    
Other Study ID Numbers: ZJCH-E-E
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: September 15, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases