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

• Status: Completed
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

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.