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

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ClinicalTrials.gov Identifier: NCT02721550
Recruitment Status : Recruiting
First Posted : March 29, 2016
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
Jinming Yu, Shandong Cancer Hospital and Institute

Brief Summary:
This is a perspective, multicenter,single arm, open label, Phase 2 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.

Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Drug: Sodium Glycididazole Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Perspective Phase II Trial of Sodium Glycididazole Combined With Preoperatie Concurrent Chemoradiotherapy for Locally Advanced Squamous Cell Esophageal Carcinoma
Study Start Date : September 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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

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.




Primary Outcome Measures :
  1. pathologic Complete Response [ Time Frame: 1 months ]
    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.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 36 months ]
  2. Disease-Free Survival [ Time Frame: 36 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721550


Contacts
Contact: Jinming Yu, Ph.D, M.D 13806406293 sdyujinming@126.com
Contact: Ligang Xing, Ph.D, M.D 15553181309 xinglg@medmail.com.cn

Locations
China, Shandong
Qianfoshan Hospital of Shandong Recruiting
Jinan, Shandong, China, 250117
Contact: Jiandong Zhang    13583123486      
Shandong Cancer Hospital and Institute Recruiting
Jinan, Shandong, China, 250117
Contact: Jinming Yu         
Jining NO.1 People's Hospital Recruiting
Jining, Shandong, China, 250117
Contact: Peipei Wu    15853770581      
Liaocheng People Hospital Recruiting
Liaocheng, Shandong, China
Contact: Mingjun Li         
Qingdao Center Medical Group Recruiting
Qingdao, Shandong, China, 250117
Contact: Xuezhen Ma         
Rizhao City People 's Hospital Recruiting
Rizhao, Shandong, China
Contact: Yufeng Li         
Fei Cheng People's Hospital Recruiting
Tai'an, Shandong, China, 250117
Contact: Wenyuan Zhao    13518688689      
An Qiu People's Hospital Recruiting
Weifang, Shandong, China, 250117
Contact: Chuandong Wang    15605368369      
The Fourth People's Hospitalof Zibo Recruiting
Zibo, Shandong, China, 250117
Contact: Qiang Zhang    13345221111      
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Investigators
Principal Investigator: Jinming Yu, Ph.D, M.D Shandong Cancer Hospital and Institute

Responsible Party: Jinming Yu, president, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT02721550     History of Changes
Other Study ID Numbers: CMNAER1
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases