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

Sun Yat-sen University

Status and phase: Completed; Phase 2

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Combination Product: Moderately hypofractionated conformal radiation combined With S-1

Study type: Interventional

Funder types: Other

Identifiers

NCT03660449

GASTO-1045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

Experiment

Experimental group

Description:

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.

Treatment:

Combination Product: Moderately hypofractionated conformal radiation combined With S-1