Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02721550
Other study ID # CMNAER1
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date August 1, 2016
Est. completion date June 30, 2018

Study information

Verified date October 2019
Source Shandong Cancer Hospital and Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China 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

Sponsors (1)

Lead Sponsor Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Overall Survival 36 months
Secondary Disease-Free Survival 36 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05013697 - TQB2450 Solution for Injection (TQB2450)+Paclitaxel+Cisplatin ± Anlotinib in the Treatment of Esophageal Cancer. Phase 2
Completed NCT02253602 - Innovative MRI Techniques to Improve Treatment Stratification of Patients With Esophageal Cancer N/A
Completed NCT02128243 - Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer Phase 2
Completed NCT01900691 - Removal of the Evolution® Esophageal Stent - Fully Covered N/A
Completed NCT01719926 - Phase I Platinum Based Chemotherapy Plus Indomethacin Phase 1
Terminated NCT01572987 - Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus N/A
Terminated NCT00760604 - A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Esophageal Cancer Phase 3
Completed NCT00160030 - Study Comparing Radiochemotherapy With Folfox 4 Regimen or 5FU-Cisplatin in Patients With Inoperable Esophageal Cancer Phase 2
Suspended NCT00048529 - Study of T900607-Sodium in Subjects With Previously Treated Gastric Cancer or Adenocarcinoma of the Esophagus Phase 2
Recruiting NCT05007106 - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Phase 2
Completed NCT02284802 - Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy N/A
Terminated NCT03223662 - Metabolomic and BH3 Profiling of Esophageal Cancers: Identification of Novel Assessment Methods of Treatment Response for Precision Therapy Phase 2
Completed NCT05680077 - KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)
Completed NCT03549494 - Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction Phase 2
Completed NCT03261947 - A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors Phase 2
Terminated NCT00094978 - Depsipeptide/Flavopiridol Infusion for Cancers of the Lungs, Esophagus, Pleura, Thymus or Mediastinum Phase 1
Recruiting NCT02908204 - Long-term Outcomes of Superficial Esophageal Squamous Cell Carcinoma N/A
Completed NCT02703142 - Endoscopic Evaluation After Esophagectomy N/A
Completed NCT02378948 - Nutritional Route In Esophageal Resection Trial II N/A
Recruiting NCT02604615 - The Role of Different Cycles of Chemotherapy(Capecitabine-oxaliplatin) in Esophageal Chemoradiotherapy Phase 3