Moderately Hypofractionated Conformal Radiation Combined With S-1 for Esophageal Squamous Cell Carcinoma

Phase 2

Completed

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Combination Product: Moderately hypofractionated conformal radiation combined With S-1

• Registration Number: NCT03660449
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-06
• Primary Completion: 2022-07-30
• Study Completion: 2022-07-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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
• 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
Experiment	Moderately hypofractionated conformal radiation combined With S-1	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.

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	3 years

Secondary Outcome Measures

Name	Time	Method
rate of grade 3-4 radiation esophagitis	1 year
rate of grade 3-4 radiation pneumonitis	1 year
Overall Survival	3 years

Trial Locations

Locations (1)

Hui Liu; 🇨🇳 Guangzhou, Guangdong, China