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

September 2, 2020 updated by: Hui Liu, Sun Yat-sen University

A Prospective, Single-arm Study of Simultaneous Modulated Accelerated Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Carcinoma.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-Sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SMART & S-1/DDP
Patients in experimental group receive daily simultaneous modulated accelerated radiotherapy combined with DDP and S-1.
Radiation: SMART
Once-daily simultaneous modulated accelerated radiotherapy(64Gy/30f )
Drug: DDP
DDP(25 mg/m2.qw) for six weeks.
Drug: S-1
S-1(40 mg/m2.Bid .po) on D1-14，D22-35 during radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response rate
Time Frame: 2-year
the percentage of patients who had partial remission or complete remission after chemoradiotherapy
2-year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

November 14, 2015

First Submitted That Met QC Criteria

November 14, 2015

First Posted (Estimate)

November 17, 2015

Study Record Updates

Last Update Posted (Actual)

September 4, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GYX2015-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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