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

Esophageal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02721550
• Other study ID #: CMNAER1
• Status: Terminated
• Phase: Phase 4
• Start date: August 1, 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,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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 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 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

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

Drug:
• Sodium Glycididazole
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.

Locations

Country	Name	City	State
China	Qianfoshan Hospital of Shandong	Jinan	Shandong
China	Shandong Cancer Hospital and Institute	Jinan	Shandong
China	Jining NO.1 People's Hospital	Jining	Shandong
China	Liaocheng People 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	pathologic Complete Response	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.	1 months
Secondary	Overall Survival		36 months
Secondary	Disease-Free Survival		36 months