Esophageal Neoplasms
Conditions
Brief summary
This is a perspective, multicenter,randomized controlled trial to evaluate the efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in patients with locally advanced squamous cell esophageal carcinoma . Analyses of primary objective (ORR) will be done as defined in the protocol.
Detailed description
The primary end point of this study is objective response rate.The secondary end point is OS, PFS and the safty of drug. The primary hypothesis is the CMNa will improve ORR and thus improve OS, PFS. Assuming bilateral a=0.05, statistical power of 80%.The total sample size is 104 cases.
Interventions
Sodium Glycididazole 700mg/m2.Three times a week (once every other one day),before radiation therapy, total 6 weeks.
DRUGPlacebo
Placebo:three times a week (once every other one day),before radiation therapy, total 6 weeks.
Sponsors
Shandong Cancer Hospital and Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Signed written informed consent prior to study entry 2. Patients with ESCC in upper and middle thoracic segment（stage II-III）confirmed by imaging and pathology or cytology, which is unsuitable or refuse surgery; 3. Capable for chemo-radiotherapy; 4. The existence of measurable lesions; 5. ECOG PS of 0 or 1 6. Possible semi-liquid diet; 7. Expected lifetime≥3 months 8. normal bone marrow reserve: ANCcount ≥1500/mm3;platelet count ≥100,000/ mm3,hemoglobin≥9g/dl 9. normal hepatic funcion:bilirubin level ≤1.5×ULN;AST/ALT≤1.5×ULN 10. normal renal function: serum creatinine≤1.5mg/dl and calculated creatinine clearance ≥60ml/min 11. normal cardiac function 12. Subjects tumor tissue available for the relevant biomarker detection
Exclusion criteria
1. Female subject who is during pregnancy or lactation, and the subject who have fertility don't take effective contraception during study 2. Any mental illness or nervous system lesions or can't tell treatment response clearly (such as cerebrovascular accident sequelae) 3. Any serious uncontrolled disease and infection, such as severe heart, liver, kidney diseases or diabetes, can't complete the treatment plan 4. Patients who have other malignant lesions, except curable skin cancer (non-melanoma skin cancer),carcinoma in situ of cervix or serve disease cured for 5 years 5. Primary lesions were multifocal 6. Patients who have obvious esophageal ulcers or have above moderate pains in chest-back or have symptoms of esophageal perforation 7. received anti-cancer treatment of esophageal cancer before the group, including surgery, radiotherapy, chemotherapy (induction of chemotherapy before the group is greater than or equal to two cycles). 8. Not esophageal squamous carcinoma confirmed by pathology or cytology 9. History of active hepatitis 10. Unable to comprehend the study requirement or who are not likely to comply with the study requirements 11. Significant disease which, in the investigator's opinion, would exclude the patient from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 36 months |
| Progression free survival | 36 months |
Countries
China
Outcome results
None listed