Clinical trial NCT02721550: A Trial of CMNa Combined With Preoperatie Concurrent Chemoradiotherapy for Locally Advanced ESCC
Official title: A Perspective Trial of Sodium Glycididazole Combined With Preoperatie Concurrent Chemoradiotherapy for Locally Advanced Squamous Cell Esophageal Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Esophageal Neoplasms
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: pathologic Complete Response
timeFrame: 1 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 36 months
measure: Disease-Free Survival
timeFrame: 36 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital of Shandong
state: Shandong
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
city: Jining
country: China
facility: Jining NO.1 People's Hospital
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Center Medical Group
state: Shandong
city: Rizhao
country: China
facility: Rizhao City People 's Hospital
state: Shandong
city: Tai'an
country: China
facility: Fei Cheng People's Hospital
state: Shandong
city: Weifang
country: China
facility: An Qiu People's Hospital
state: Shandong
city: Zibo
country: China
facility: The Fourth People's Hospitalof Zibo
state: Shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Jinming Yu, Ph.D, M.D
role: PRINCIPAL_INVESTIGATOR
References: