A Trial of CMNa Combined With Definitive Concurrent Chemoradiotherapy for Locally Advanced ESCC

Esophageal Neoplasms Clinical Trial

Official title:

A Perspective Random Trial of Sodium Glycididazole Combined With Definitive Concurrent Chemoradiotherapy for Locally Advanced Squamous Cell Esophageal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02721563
• Other study ID #: CMNAER2
• Status: Completed
• Phase: Phase 4
• Start date: February 25, 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: October 2019
• Source: Shandong Cancer Hospital and Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: June 30, 2018
• Est. primary completion date: June 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

Drug:
• Sodium Glycididazole
Sodium Glycididazole 700mg/m2.Three times a week (once every other one day),before radiation therapy, total 6 weeks.
• Placebo
Placebo:three times a week (once every other one day),before radiation therapy, total 6 weeks.

Locations

Country	Name	City	State
China	Qianfoshan Hospital of Shandong	Jinan	Shandong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Shandong Cancer Hospital and Institute	Jinan	Shandong
China	Jining NO.1 People's Hospital	Jining	Shandong
China	Liaocheng People 's Hospital	Liaocheng	Shandong
China	Qingdao Center Medical Group	Qingdao	Shandong
China	Rizhao City People 's Hospital	Rizhao	Shandong
China	Fei Cheng People's Hospital	Tai'an	Shandong
China	An Qiu People's Hospital	Weifang	Shandong
China	The Fourth People's Hospitalof Zibo	Zibo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate		3 months
Secondary	Overall survival		36 months
Secondary	Progression free survival		36 months