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

Phase 2

Completed

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Radiation: SMART; Drug: DDP; Drug: S-1

• Registration Number: NCT02606916
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-11-14
• Study First Submitted QC: 2015-11-14
• Study First Posted: 2015-11-17
• Primary Completion: 2020-08
• Study Completion: 2020-08
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SMART & S-1/DDP	SMART	Patients in experimental group receive daily simultaneous modulated accelerated radiotherapy combined with DDP and S-1.
SMART & S-1/DDP	S-1	Patients in experimental group receive daily simultaneous modulated accelerated radiotherapy combined with DDP and S-1.
SMART & S-1/DDP	DDP	Patients in experimental group receive daily simultaneous modulated accelerated radiotherapy combined with DDP and S-1.

Primary Outcome Measures

Name	Time	Method
Clinical response rate	2-year	the percentage of patients who had partial remission or complete remission after chemoradiotherapy

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sun yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China