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

Primary Purpose

Esophageal Neoplasms

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sodium Glycididazole
Placebo
Sponsored by
Shandong Cancer Hospital and Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Qianfoshan Hospital of Shandong
  • Qilu Hospital of Shandong University
  • Shandong Cancer Hospital and Institute
  • Jining NO.1 People's Hospital
  • Liaocheng People 's Hospital
  • Qingdao Center Medical Group
  • Rizhao City People 's Hospital
  • Fei Cheng People's Hospital
  • An Qiu People's Hospital
  • The Fourth People's Hospitalof Zibo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sodium Glycididazole

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Objective response rate

Secondary Outcome Measures

Overall survival
Progression free survival

Full Information

First Posted
March 9, 2016
Last Updated
October 10, 2019
Sponsor
Shandong Cancer Hospital and Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02721563
Brief Title
A Trial of CMNa Combined With Definitive Concurrent Chemoradiotherapy for Locally Advanced ESCC
Official Title
A Perspective Random Trial of Sodium Glycididazole Combined With Definitive Concurrent Chemoradiotherapy for Locally Advanced Squamous Cell Esophageal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 25, 2016 (Actual)
Primary Completion Date
June 10, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong Cancer Hospital and Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium Glycididazole
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Sodium Glycididazole
Intervention Description
Sodium Glycididazole 700mg/m2.Three times a week (once every other one day),before radiation therapy, total 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo:three times a week (once every other one day),before radiation therapy, total 6 weeks.
Primary Outcome Measure Information:
Title
Objective response rate
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
36 months
Title
Progression free survival
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinming Yu, Ph.D, M.D
Organizational Affiliation
Shandong Cancer Hospital and Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qianfoshan Hospital of Shandong
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
Shandong Cancer Hospital and Institute
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
Jining NO.1 People's Hospital
City
Jining
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
Liaocheng People 's Hospital
City
Liaocheng
State/Province
Shandong
Country
China
Facility Name
Qingdao Center Medical Group
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
Rizhao City People 's Hospital
City
Rizhao
State/Province
Shandong
Country
China
Facility Name
Fei Cheng People's Hospital
City
Tai'an
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
An Qiu People's Hospital
City
Weifang
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
The Fourth People's Hospitalof Zibo
City
Zibo
State/Province
Shandong
ZIP/Postal Code
250117
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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