A Prospective, Phase Ⅱ Study of S-1 Plus Moderately Hypofractionated Conformal Radiation for Esophageal Squamous Cell Carcinoma

Sun Yat-sen University1 site in 1 country58 target enrollmentOctober 1, 2017

ConditionsEsophageal Squamous Cell Carcinoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: Sun Yat-sen University
Enrollment: 58
Locations: 1
Primary Endpoint: Progression-Free Survival
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This Phase II randomized study is to determine the efficacy and toxicities of moderately hypofractionated conformal radiation combined With S-1 for esophageal squamous cell carcinoma.

Detailed Description

This Phase II randomized study is to determine the efficacy and toxicities of moderately hypofractionated conformal radiation combined With S-1 for esophageal squamous cell carcinoma. All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV. The primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date on which disease progresses. Progression-free survival will be calculated and compared using the Kaplan-Meier method.Toxicities will be graded according to CTCAE v. 4.0.

Registry

clinicaltrials.gov

Start Date

October 1, 2017

End Date

July 30, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Hui Liu

Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed esophageal squamous cell carcinoma
•Inoperable stage II-IVa (UICC 2002; sixth edition), confirmed by contrast enhanced computed tomography,endoscopic ultrasonography, barium esophagram, emission computed tomography and/or positron emission tomography/computed tomography.
•Eastern Cooperative Oncology Group (ECOG) performance status 1-2
•Estimated life expectancy of at least 12 weeks
•Charlson comorbidity index.4
•Adequate bone marrow function: white blood cells grade 0 or 1,absolute neutrophils grade 0 or 1, platelets grade 0, haemoglobin grade 0 or 1
•Adequate renal function: creatinine grade 0 or 1
•Adequate liver function: serum bilirubin grade 0 or 1, alanine aminotransferase and aspartate aminotransferase \<2 times of the upper normal limit
•Weight loss.15% during 6 months prior to diagnosis
•Forced expiratory volume second.1L

Exclusion Criteria

•Prior history of malignancy, except for nonmelanoma skin carcinoma or cervical carcinoma in situ
•Previous anti-tumor therapy, including surgery, chemotherapy or radiotherapy
•Contraindication for chemotherapy or radiotherapy
•Malignant pleural or pericardial effusion
•Women in pregnancy or lactation period
•Women who has the probability of pregnancy without contraception
•Weight loss≥15% during 3 months prior to diagnosis
•In other clinical trials within 30 days
•Addicted in drugs or alcohol, AIDS patients
•Uncontrollable seizure or psychotic patients without self-control ability