NCT02721563

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2016

Typical duration for phase_4

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2018

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

October 11, 2019

Status Verified

October 1, 2019

Enrollment Period

2.3 years

First QC Date

March 9, 2016

Last Update Submit

October 10, 2019

Conditions

Esophageal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    3 months

Secondary Outcomes (2)

  • Overall survival

    36 months

  • Progression free survival

    36 months

Study Arms (2)

Sodium Glycididazole

ACTIVE COMPARATOR

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 1-6 Cisplatin:20 mg/m²,d1,week 1-6 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,T60Gy/30f,week 1-6

Drug: Sodium Glycididazole

Control Group

PLACEBO COMPARATOR

Placebo：dissolved in 100mlphysiological 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 6 weeks course.Chemotherapy Paclitaxel:45 mg/m²,d1,week 1-6 Cisplatin:20 mg/m²,d1,week 1-6 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, 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,T60Gy/30f,week 1-6

Drug: Placebo

Interventions

Sodium GlycididazoleDRUG

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

Sodium Glycididazole
PlaceboDRUG

Placebo:three times a week (once every other one day),before radiation therapy, total 6 weeks.

Control Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed written informed consent prior to study entry
  • 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;
  • Capable for chemo-radiotherapy;
  • The existence of measurable lesions;
  • ECOG PS of 0 or 1
  • Possible semi-liquid diet;
  • Expected lifetime≥3 months
  • 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
  • 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 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).
  • Not esophageal squamous carcinoma confirmed by pathology or cytology
  • History of active hepatitis
  • Unable to comprehend the study requirement or who are not likely to comply with the study requirements
  • Significant disease which, in the investigator's opinion, would exclude the patient from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Qianfoshan Hospital of Shandong

Jinan, Shandong, 250117, China

Location

Qilu Hospital of Shandong University

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 's 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 NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal 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
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
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

February 25, 2016

Primary Completion

June 10, 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(10)