Clinical trial NCT02606916: Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Cancer.
Official title: A Prospective, Single-arm Study of Simultaneous Modulated Accelerated Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Carcinoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: Once-daily Simultaneous Modulated Accelerated Radiotherapy
S-1
DDP
elderly patients
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 42
Sex: ALL
Minimum age (years): 70
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Clinical response rate
timeFrame: 2-year
Secondary outcomes:
measure: progression-free survival
timeFrame: 3-year
measure: overall survival
timeFrame: 3-year
measure: grade 3 or 4 toxicities according to CTCAE4.0
timeFrame: 1 year after radiochemotherapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Hui Liu, Professor
role: PRINCIPAL_INVESTIGATOR
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