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

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
S-1
Radiation therapy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fudan University Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

S-1

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants with adverse events
3-yr local control rate

Secondary Outcome Measures

Overall survival

Full Information

First Posted
April 11, 2013
Last Updated
February 14, 2019
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT01831531
Brief Title
Study of S-1 in Combination With Radiotherapy in Esophageal Cancer
Official Title
Phase II Study of S-1 in Combination With Radiotherapy in Esophageal Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S-1
Arm Type
Experimental
Arm Description
Patients will receive chemoradiation with S-1. Interventions: Drug: S-1 Radiation: Radiation therapy
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
S-1 40 mg (BSA ≤ 1.6 m2) or 50 mg (BSA >1.6 m2) p.o bid d1-28
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
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 Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
1 years
Title
3-yr local control rate
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuaile Zhao, M.D.
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35449578
Citation
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.
Results Reference
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Study of S-1 in Combination With Radiotherapy in Esophageal Cancer

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