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

NCT ID: NCT02721550

Last Updated: 2019-10-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-01
• Study Completion Date: 2018-06-30

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.

Conditions

Esophageal Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sodium Glycididazole

Sodium Glycididazole：800mg/m2，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. Chemotherapy Paclitaxel:45 mg/m²,d1,week 1-4 Cisplatin:20 mg/m²,d1,week 1-4 OR Docetaxel: 75 mg / m², 1 day or divided into D1, D8 days, 21 days / cycle. Cisplatin: 75 mg / m², divided into D1-D3 days or D1-D5 days, 21 days / cycle. Or nedaplatin: 80 mg / m², 21 days / cycle.

OR 5-FU: 500 mg / m² / day, divided into D1 ~ D5 for use, 21 days / cycle. Cisplatin: 75 mg / m² / day, divided into D1-D3 day or D1-D5 days, 21 days / cycle. Or nedaplatin: 80 mg / m², 21 days / cycle 3DCRT/IMRT:2.0Gy/f/day,T40Gy/20f,week 1-4

Group Type: EXPERIMENTAL

Sodium Glycididazole

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: lead

Responsible Party

Jinming Yu

president

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinming Yu, Ph.D, M.D

Role: PRINCIPAL_INVESTIGATOR

Shandong Cancer Hospital and Institute

Locations

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, China

Countries

China

Other Identifiers

CMNAER1

Identifier Type: -

Identifier Source: org_study_id