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

NCT ID: NCT01831531

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2018-10-31

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.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S-1

Patients will receive chemoradiation with S-1.

Interventions:

Drug: S-1 Radiation: Radiation therapy

Group Type: EXPERIMENTAL

S-1

Intervention Type: DRUG

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

Radiation therapy

Intervention Type: RADIATION

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.

Interventions

S-1

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

Intervention Type: DRUG

Radiation 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.

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Kuai Le Zhao, MD

Professor of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kuaile Zhao, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

References

Chen Y, Zhu Z, Zhao W, Liu Q, Zhang J, Deng J, Ai D, Lu S, Jiang L, Tseng I, Jia H, Zhao K. Long-Term Results of a Phase 2 Study of Definitive Chemoradiation Therapy Using S-1 for Esophageal Squamous Cell Carcinoma Patients Who Were Elderly or With Serious Comorbidities. Front Oncol. 2022 Apr 5;12:839765. doi: 10.3389/fonc.2022.839765. eCollection 2022.

Reference Type: DERIVED

PMID: 35449578 (View on PubMed)

Other Identifiers

ESO-Shanghai7

Identifier Type: -

Identifier Source: org_study_id