Esophageal Neoplasms
Conditions
Brief summary
This is a perspective, multicenter,single arm, open label study to evaluate the efficacy and safety of treatment with CMNa combined with preoperatie concurrent chemoradiotherapy in patients with locally advanced squamous cell esophageal carcinoma . Analyses of primary objective (pathologic Complete Response) will be done as defined in the protocol.
Detailed description
The primary end ponit of this study is pathological complete response.And the primary hypothesis is the CMNa will improve patholofical response rate and thus improve OS、DFS. Assuming bilateral a=0.05, statistical power of 80%.The total sample size is 40 cases.
Interventions
800mg/m2，dissolved in 100ml physiological saline(Now with chef),ivgtt,finished in 30 minutes,within 60 minutes after intravenous drip for radiation therapy.Three times a week (once every other one day),before radiation therapy, total 4 weeks course.
Sponsors
Shandong Cancer Hospital and Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 thoracic segment which is resectable（T2-3，N0-1，M0） confirmed by imaging and pathology or cytology; 3. Patients have tumor lesions which can be objectively measured ,the length of tumor:≤8cm, the width of tumor:≤5cm;If the tumor cross the GEJ and violate the proximal stomach, the tumor must include esophagus and GEJ. The tumor is less than 2cm of the stomach 4. Not infringe bronchial wall; no esophagus-tracheal fistula. 5. normal bone marrow reserve: ANCcount ≥1500/mm3;platelet count ≥100,000/mm3,hemoglobin≥9g/dl 6. normal hepatic funcion:bilirubin level ≤1.5×ULN;AST/ALT≤1.5×ULN 7. normal renal function: serum creatinine≤1.5mg/dl and calculated creatinine clearance ≥60ml/min 8. normal cardiac function 9. ECOG PS of 0 or 1 10. Expected lifetime≥3 months 11. 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 with distant metastasis. A small amount of stomach tumor violate GEJ or the distal esophageal. 7. Patients who have obvious esophageal ulcers or have above moderate pains in chest-back or have symptoms of esophageal perforation 8. 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). 9. Cervical esophageal cancer confirmed by iconography 10. Not esophageal squamous carcinoma confirmed by pathology or cytology 11. History of active hepatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathologic Complete Response | 1 months | TRG-cited from Mandard AM, Dalibard F, Mandard JC, Marnay J, Henry-Amar M, Petiot JF, Roussel A, Jacob JH, Segol P, Samama G, Pathologic assessment of tumor regression after preoperative chemoradiotherapy of esophageal carcinoma. Cancer, 73, 2680-2686, 1994. |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | 36 months |
| Disease-Free Survival | 36 months |
Countries
China
Outcome results
None listed