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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02606916

Enrollment

Registered

2015-11-17

Start date

2015-07-31

Completion date

2020-08-31

Last updated

2020-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Once-daily Simultaneous Modulated Accelerated Radiotherapy, S-1, DDP, elderly patients

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.

Interventions

RADIATIONSMART

Once-daily simultaneous modulated accelerated radiotherapy(64Gy/30f )

DRUGDDP

DDP(25 mg/m2.qw) for six weeks.

DRUGS-1

S-1(40 mg/m2.Bid .po) on D1-14，D22-35 during radiotherapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Clinical response rate	2-year	the percentage of patients who had partial remission or complete remission after chemoradiotherapy

Secondary

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026