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CompletedNCT01831531Updated Feb 15, 2019

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

A Phase 2 interventional study of S-1 and Radiation therapy in Esophageal Squamous Cell Carcinoma, sponsored by Fudan University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
105
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

03

In context

Carcinoma

6,738 studies on the registry are indexed under Carcinoma; 1,159 are open to participants now.

This study's enrollment of 105 is above the median of 45 across 5,167 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Fudan University is the lead sponsor of 1,271 studies on the registry; 624 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
105 participants (actual)

Study arms

  • Experimental
    S-1

    Patients will receive chemoradiation with S-1. Interventions: Drug: S-1 Radiation: Radiation therapy

    Drug: S-1 · Radiation: Radiation therapy

Interventions

  • DrugS-1

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

  • RadiationRadiation therapy

    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.

06

What researchers measure

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

07

Study locations

1 site
  • Fudan University Cancer Center
    Shanghai, Shanghai 200032, China
08

References and documents

Publications

  • Chen Y, Zhu Z, Zhao W, Liu Q, Zhang J, Deng J, Ai D, Lu S, Jiang L, Tseng I, Jia H, Zhao K. Long-Term Results of a Phase 2 Study of Definitive Chemoradiation Therapy Using S-1 for Esophageal Squamous Cell Carcinoma Patients Who Were Elderly or With Serious Comorbidities. Front Oncol. 2022 Apr 5;12:839765. doi: 10.3389/fonc.2022.839765. eCollection 2022. PubMed 35449578 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01831531
Lead sponsor
Fudan University
Responsible party
Kuai Le Zhao, MD (Professor of Radiation Oncology, Fudan University) — Principal investigator
First posted
Apr 15, 2013
Start date
Mar 2013
Primary completion
Oct 2018
Completion
Oct 2018
Last update
Feb 15, 2019

Study contacts

Kuaile Zhao, M.D.
principal investigator · Fudan University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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