Overview

This trial is active, not recruiting.

Condition esophageal squamous cell carcinoma
Treatments s-1, radiation therapy
Phase phase 2
Sponsor Fudan University
Start date March 2013
End date October 2018
Trial size 105 participants
Trial identifier NCT01831531, ESO-Shanghai7

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients will receive chemoradiation with S-1. Interventions: Drug: S-1 Radiation: Radiation therapy
s-1
S-1 40 mg (BSA ≤ 1.6 m2) or 50 mg (BSA >1.6 m2) p.o bid d1-28
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.

Primary Outcomes

Measure
Number of participants with adverse events
time frame: 1 years
1-yr local control rate
time frame: 1 year
2-yr local control rate
time frame: 2 years
3-yr local control rate
time frame: 3 years

Secondary Outcomes

Measure
1-yr overall survival
time frame: 1 year
2-yr overall survival
time frame: 2 years
3-yr overall survival
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Study of S-1 in Combination With Radiotherapy in Esophageal Squamous Cell Carcinoma
Principal investigator Kuaile Zhao, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Fudan University.