Study of S-1 in Combination With Radiotherapy in Esophageal Cancer
Conditions
Esophageal Squamous Cell Carcinoma
Conditions: official terms
Carcinoma, Squamous Cell - Esophageal Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: S-1 Type: Drug
Name: Radiation therapy Type: Radiation
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Fudan University Cancer Center
Shanghai, Shanghai, China
Status: Recruiting
Contact: Yun Chen, M.M. - 8621-64175590 - chenyun_qz@hotmail.com
Start Date
March 2013
Completion Date
March 2018
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page