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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01831531
• Other study ID #: ESO-Shanghai7
• Status: Completed
• Phase: Phase 2
• Start date: March 2013
• Est. completion date: October 2018

Study information

• Verified date: February 2019
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• S-1
S-1 40 mg (BSA = 1.6 m2) or 50 mg (BSA >1.6 m2) p.o bid d1-28

Radiation:
• 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.

Locations

Country	Name	City	State
China	Fudan University Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		1 years
Primary	3-yr local control rate		3 years
Secondary	Overall survival		3 years