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

NCT03660449 | Completed Phase 2

• 1 other identifier: GASTO-1045
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Esophageal Squamous Cell Carcinoma; Hypofractionated Conformal Radiation; S-1

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  3 years

Secondary Outcomes (3)

• Overall Survival

  3 years

• rate of grade 3-4 radiation esophagitis

  1 year

• rate of grade 3-4 radiation pneumonitis

  1 year

Study Arms (1)

Experiment

EXPERIMENTAL

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.

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

Interventions

Moderately hypofractionated conformal radiation combined With S-1 COMBINATION_PRODUCT

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.

Experiment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Hui Liu

Guangzhou, Guangdong, 510000, China

Location

Related Publications (18)

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  PMID: 36969023 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Hui Liu, Ph.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 6, 2018
• Study Start: October 1, 2017
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)