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Completed

NCT Number: NCT01831531

Study of S-1 in Combination With Radiotherapy in Esophageal Cancer

This trial aims to study the safety, the local control, and the overall survival of S-1 combined with radiotherapy for patients with esophageal squamous cell carcinoma. 105 patients will be recruited into this trial.

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Key information

Conditions

Esophageal Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Joined the study voluntarily and signed informed consent form;
  • Age >75 or age 18-75 who are intolerant of or reject intravenous chemotherapy
  • Both genders
  • Esophageal squamous cell carcinoma confirmed by pathology
  • Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a, AJCC 6th)
  • No radiotherapy, chemotherapy or other treatments prior to enrollment
  • PS ECOG 0-2
  • Life expectancy of more than 3 months
  • Hemoglobin（Hb）≥9 g/dL
  • WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L
  • platelet count (Pt) ≥100x 109/L
  • Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN
  • Renal function: creatinine < 1.5 x ULN
  • No immuno-deficiency
  • Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion criteria

  • Complete esophageal obstruction
  • Deep esophageal ulcer
  • Esophageal perforation
  • Haematemesis
  • After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy
  • Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
  • Participation in other interventional clinical trials within 30 days
  • Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
  • Drug addiction
  • Alcoholism or AIDS
  • Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
  • Patient who has metastasis such as lung, liver metastasis

Treatment and study plan

S-1

Drug

S-1 40 mg (BSA ≤ 1.6 m2) or 50 mg (BSA >1.6 m2) p.o bid d1-28

radiation therapy

Radiation

A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.

Primary outcomes

  1. Number of participants with adverse events

    Time frame: 1 years

  2. 3-yr local control rate

    Time frame: 3 years

Secondary outcomes

  1. Overall survival

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Phase II Study of S-1 in Combination With Radiotherapy in Esophageal Squamous Cell Carcinoma

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Apr 15, 2013
Registry last updated
Feb 15, 2019

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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