Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Cancer.
NCT ID: NCT02606916
Last Updated: 2020-09-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
42 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-07-31
Study Completion Date
2020-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Esophageal Squamous Cell Carcinoma
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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SMART & S-1/DDP
Patients in experimental group receive daily simultaneous modulated accelerated radiotherapy combined with DDP and S-1.
Group Type
EXPERIMENTAL
SMART
Intervention Type
RADIATION
Once-daily simultaneous modulated accelerated radiotherapy(64Gy/30f )
DDP
Intervention Type
DRUG
DDP(25 mg/m2.qw) for six weeks.
S-1
Intervention Type
DRUG
S-1(40 mg/m2.Bid .po) on D1-14，D22-35 during radiotherapy
Interventions
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SMART
Once-daily simultaneous modulated accelerated radiotherapy(64Gy/30f )
Intervention Type
RADIATION
DDP
DDP(25 mg/m2.qw) for six weeks.
Intervention Type
DRUG
S-1
S-1(40 mg/m2.Bid .po) on D1-14，D22-35 during radiotherapy
Intervention Type
DRUG
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
70 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Sun Yat-sen University
OTHER
Sponsor Role
lead
Responsible Party
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Hui Liu
professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Hui Liu, Professor
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China
Site Status
Countries
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China
References
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Other Identifiers
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GYX2015-012
Identifier Type: -
Identifier Source: org_study_id
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