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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT02606916

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Cell Carcinoma	Radiation: SMART Drug: DDP Drug: S-1	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Aug 1, 2020

Actual Study Completion Date :

Aug 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Clinical response rate [2-year]
the percentage of patients who had partial remission or complete remission after chemoradiotherapy

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.