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NCT Number: NCT02813967

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

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.

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Key information

Conditions

Esophageal Cancer Chemoradiation Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

70 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy 54 Gy

Radiation

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

Radiotherapy 60 Gy

Radiation

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

S-1

Drug

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

Primary outcomes

  1. Overall survival

    Time frame: 5 years

    2-year over survival

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 27, 2016
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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