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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03660449

Enrollment

Registered

2018-09-06

Start date

2017-10-01

Completion date

2022-07-30

Last updated

2022-10-26

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

Esophageal Squamous Cell Carcinoma, Hypofractionated Conformal Radiation, S-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.

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.

Interventions

COMBINATION_PRODUCTModerately 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival	3 years

Secondary

Measure	Time frame
Overall Survival	3 years
rate of grade 3-4 radiation esophagitis	1 year
rate of grade 3-4 radiation pneumonitis	1 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026