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Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Cancer.

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SMART
DDP
S-1
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring Once-daily Simultaneous Modulated Accelerated Radiotherapy, S-1, DDP, elderly patients

Eligibility Criteria

70 Years - 80 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pathologically or cytologically confirmed esophageal squamous cell carcinoma.
  • Stage II-IVa ESCC confirmed by endoscopic ultrasonography(EUS) and imaging studies.
  • Aging from 70 to 80.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Charlson's weighted index of comorbidities (WIC) ≤4；
  • White blood cell count ≥4×109 /L, neutrophile granulocyte count≥1.5×109 /L, platelet count≥100×109 /L, hemoglobin ≥100 g /L, serum creatinine and bilirubin 1.5 times less than the upper limits of normal (ULN),aminotransferase two times less than the ULN.
  • Weight loss ≤15% within the past half year.
  • Forced expiratory volume in 1 s≥ 1 L.
  • Patients and their family signed the informed consents.

Exclusion Criteria:

  • Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ.
  • Already received antineoplastic therapy,including chemotherapy, radiotherapy or operation.
  • Any contraindication for chemotherapy or radiotherapy(such as a myocardial infarction within 6 months,immunosuppressive therapy,symptomatic heart disease,including unstable angina pectoris, congestive heart failure,and uncontrolled arrhythmia.)
  • Malignant pleural effusion or pericardial effusion.
  • Weight loss >10% within the past 3 months.
  • Recruited in other clinical trials within 30 days
  • Drug addiction, long-term alcohol abuse and AIDS patients.
  • Uncontrollable epileptic attack or psychotic patients without self-control ability.
  • Severe allergy or idiosyncrasy.
  • Not suitable for this study judged by researchers.

Sites / Locations

  • Sun yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SMART & S-1/DDP

Arm Description

Patients in experimental group receive daily simultaneous modulated accelerated radiotherapy combined with DDP and S-1.

Outcomes

Primary Outcome Measures

Clinical response rate
the percentage of patients who had partial remission or complete remission after chemoradiotherapy

Secondary Outcome Measures

progression-free survival
overall survival
grade 3 or 4 toxicities according to CTCAE4.0
the percentage of patients who develop grade 3 or 4 toxicities during and 1 year after radiochemotherapy

Full Information

First Posted
November 14, 2015
Last Updated
September 2, 2020
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02606916
Brief Title
Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Cancer.
Official Title
A Prospective, Single-arm Study of Simultaneous Modulated Accelerated Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Carcinoma.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
August 2020 (Actual)
Study Completion Date
August 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This Prospective, single-arm Phase Ⅱ study is to determine the efficacy and safety of Once-daily Simultaneous Modulated Accelerated Radiotherapy combined with S-1/DDP for geratic esophageal squamous cell carcinoma patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
Once-daily Simultaneous Modulated Accelerated Radiotherapy, S-1, DDP, elderly patients

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
SMART & S-1/DDP
Arm Type
Experimental
Arm Description
Patients in experimental group receive daily simultaneous modulated accelerated radiotherapy combined with DDP and S-1.
Intervention Type
Radiation
Intervention Name(s)
SMART
Intervention Description
Once-daily simultaneous modulated accelerated radiotherapy(64Gy/30f )
Intervention Type
Drug
Intervention Name(s)
DDP
Intervention Description
DDP(25 mg/m2.qw) for six weeks.
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
S-1(40 mg/m2.Bid .po) on D1-14，D22-35 during radiotherapy
Primary Outcome Measure Information:
Title
Clinical response rate
Description
the percentage of patients who had partial remission or complete remission after chemoradiotherapy
Time Frame
2-year
Secondary Outcome Measure Information:
Title
progression-free survival
Time Frame
3-year
Title
overall survival
Time Frame
3-year
Title
grade 3 or 4 toxicities according to CTCAE4.0
Description
the percentage of patients who develop grade 3 or 4 toxicities during and 1 year after radiochemotherapy
Time Frame
1 year after radiochemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically or cytologically confirmed esophageal squamous cell carcinoma. Stage II-IVa ESCC confirmed by endoscopic ultrasonography(EUS) and imaging studies. Aging from 70 to 80. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Charlson's weighted index of comorbidities (WIC) ≤4； White blood cell count ≥4×109 /L, neutrophile granulocyte count≥1.5×109 /L, platelet count≥100×109 /L, hemoglobin ≥100 g /L, serum creatinine and bilirubin 1.5 times less than the upper limits of normal (ULN),aminotransferase two times less than the ULN. Weight loss ≤15% within the past half year. Forced expiratory volume in 1 s≥ 1 L. Patients and their family signed the informed consents. Exclusion Criteria: Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ. Already received antineoplastic therapy,including chemotherapy, radiotherapy or operation. Any contraindication for chemotherapy or radiotherapy(such as a myocardial infarction within 6 months,immunosuppressive therapy,symptomatic heart disease,including unstable angina pectoris, congestive heart failure,and uncontrolled arrhythmia.) Malignant pleural effusion or pericardial effusion. Weight loss >10% within the past 3 months. Recruited in other clinical trials within 30 days Drug addiction, long-term alcohol abuse and AIDS patients. Uncontrollable epileptic attack or psychotic patients without self-control ability. Severe allergy or idiosyncrasy. Not suitable for this study judged by researchers.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Liu, Professor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

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Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Cancer.

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