Status:
COMPLETED
Study of S-1 in Combination With Radiotherapy in Esophageal Cancer
Lead Sponsor:
Fudan University
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01831531
Start Date
March 1 2013
End Date
October 1 2018
Last Update
February 15 2019
Active Locations (1)
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1
Fudan University Cancer Center
Shanghai, Shanghai Municipality, China, 200032