Study of S-1 in Combination With Radiotherapy in Esophageal Cancer

Phase II Study of S-1 in Combination With Radiotherapy in Esophageal Squamous Cell Carcinoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01831531

Enrollment

105

Registered

2013-04-15

Start date

2013-03-31

Completion date

2018-10-31

Last updated

2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Squamous Cell Carcinoma

Brief summary

This trial aims to study the safety, the local control, and the overall survival of S-1 combined with radiotherapy for patients with esophageal squamous cell carcinoma. 105 patients will be recruited into this trial.

Interventions

DRUGS-1

S-1 40 mg (BSA ≤ 1.6 m2) or 50 mg (BSA \>1.6 m2) p.o bid d1-28

RADIATIONRadiation therapy

A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Joined the study voluntarily and signed informed consent form; * Age \>75 or age 18-75 who are intolerant of or reject intravenous chemotherapy * Both genders * Esophageal squamous cell carcinoma confirmed by pathology * Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a, AJCC 6th) * No radiotherapy, chemotherapy or other treatments prior to enrollment * PS ECOG 0-2 * Life expectancy of more than 3 months * Hemoglobin（Hb）≥9 g/dL * WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L * platelet count (Pt) ≥100x 109/L * Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\<1.5 x ULN * Renal function: creatinine \< 1.5 x ULN * No immuno-deficiency * Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion criteria

* Complete esophageal obstruction * Deep esophageal ulcer * Esophageal perforation * Haematemesis * After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy * Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years * Participation in other interventional clinical trials within 30 days * Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives * Drug addiction * Alcoholism or AIDS * Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior * Patient who has metastasis such as lung, liver metastasis

Design outcomes

Primary

Measure	Time frame
Number of participants with adverse events	1 years
3-yr local control rate	3 years

Secondary

Measure	Time frame
Overall survival	3 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026