Clinical trial NCT02721563: A Trial of CMNa Combined With Definitive Concurrent Chemoradiotherapy for Locally Advanced ESCC
Official title: A Perspective Random Trial of Sodium Glycididazole Combined With Definitive Concurrent Chemoradiotherapy for Locally Advanced Squamous Cell Esophageal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Esophageal Neoplasms
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate
timeFrame: 3 months
Secondary outcomes:
measure: Overall survival
timeFrame: 36 months
measure: Progression free survival
timeFrame: 36 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital of Shandong
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
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 's 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: