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

NCT02721550 | Terminated Phase 4 DMC

• 1 other identifier: CMNAER1
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 9

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.

Conditions

Esophageal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Survival

  36 months

• Disease-Free Survival

  36 months

Study Arms (1)

Sodium Glycididazole

EXPERIMENTAL

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

Drug: Sodium Glycididazole

Interventions

Sodium Glycididazole 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.

Sodium Glycididazole

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent prior to study entry
• Patients with ESCC in thoracic segment which is resectable（T2-3，N0-1，M0） confirmed by imaging and pathology or cytology;
• 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
• Not infringe bronchial wall; no esophagus-tracheal fistula.
• normal bone marrow reserve: ANCcount ≥1500/mm3;platelet count ≥100,000/mm3,hemoglobin≥9g/dl
• normal hepatic funcion:bilirubin level ≤1.5×ULN;AST/ALT≤1.5×ULN
• normal renal function: serum creatinine≤1.5mg/dl and calculated creatinine clearance ≥60ml/min
• normal cardiac function
• ECOG PS of 0 or 1
• Expected lifetime≥3 months
• Subjects tumor tissue available for the relevant biomarker detection

You may not qualify if:

• Female subject who is during pregnancy or lactation, and the subject who have fertility don't take effective contraception during study.
• Any mental illness or nervous system lesions or can't tell treatment response clearly (such as cerebrovascular accident sequelae)
• Any serious uncontrolled disease and infection, such as severe heart, liver, kidney diseases or diabetes, can't complete the treatment plan
• 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
• Primary lesions were multifocal
• Patients with distant metastasis. A small amount of stomach tumor violate GEJ or the distal esophageal.
• Patients who have obvious esophageal ulcers or have above moderate pains in chest-back or have symptoms of esophageal perforation
• 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).
• Cervical esophageal cancer confirmed by iconography
• Not esophageal squamous carcinoma confirmed by pathology or cytology
• History of active hepatitis

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (9)

Qianfoshan Hospital of Shandong

Jinan, Shandong, 250117, China

Location

Shandong Cancer Hospital and Institute

Jinan, Shandong, 250117, China

Location

Jining NO.1 People's Hospital

Jining, Shandong, 250117, China

Location

Liaocheng People Hospital

Liaocheng, Shandong, China

Location

Qingdao Center Medical Group

Qingdao, Shandong, 250117, China

Location

Rizhao City People 's Hospital

Rizhao, Shandong, China

Location

Fei Cheng People's Hospital

Tai’an, Shandong, 250117, China

Location

An Qiu People's Hospital

Weifang, Shandong, 250117, China

Location

The Fourth People's Hospitalof Zibo

Zibo, Shandong, 250117, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

sodium glycididazole

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Jinming Yu, Ph.D, M.D

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: president

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 29, 2016
• Study Start: August 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: October 11, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)