- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02017600
A Phase II Trial of Induction Chemotherapy With ND-420, Cisplatin and Fluorouracil Followed by Surgery in the Treatment of Patients With Localized Squamous Cell Carcinoma of the Esophagus
May 18, 2020 updated by: Nang Kuang Pharmaceutical Co., Ltd.
Investigator will assign 53 patients who had been histologically proven localized squamous cell carcinoma of esophagus to receive the induction chemotherapy regimen of ND-420 50 mg/m2 on day 1, cisplatin 70 mg/m2 on day1, plus fluorouracil 700 mg/m2 daily, day1 to day4, every 3 weeks for 2 cycles and then followed by surgical resection.
The successful rate of complete treatment per protocol and complete resection will be the primary variant to evaluate in our study.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 112
- Taipei Veterans General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have been histologically proven esophageal carcinoma (squamous cell carcinoma).
- The tumor had to be locally advanced (stage T2-3/N0, T1-3/N+, if technically resectable with curative intent).
- Patients must be 20 years of age.
- Patients must have an ECOG performance status score 2.
- Patients must have a life expectancy of at least 12 weeks.
- Patients must be accessible for treatment and follow-up at least for one year.
- Patients must sign the informed consent form.
- Patient must have:Hemoglobin level 9 g/dl; Neutrophil count 1,500/mm3; Platelets count 100,000/mm3; Serum bilirubin level 1.0 ULN; Serum transaminase (GOT, GPT) levels 2.0 ULN; Serum Alkaline phosphatase levels 2.0 ULN; Serum creatinine level 1.5 mg/dl or Creatinine clearance rate(CrCl)60 ml/min for the institution (calculated by the Cockcroft- Gault equation).
Exclusion Criteria:
- Patient who are receiving or had received concurrent radiotherapy, chemotherapy or other anticancer treatment for esophageal carcinoma.
- Patients with known history of severe hypersensitivity reactions to any medicine or to drugs formulated with polysorbate 80.
- Major surgery within two weeks prior to entering the study, excluding port-A insertion or feeding jejunostomy surgery.
- Patients with CNS metastasis, including clinical suspicion.
- Patients with clinically detectable peripheral neuropathy 2 on the CTC criteria.
- Mental statuses of patients are not fit for clinical trial.
- Fertile men and women unless using a reliable and appropriate contraceptive method.
- Patients with pregnancy or lactating, women considering pregnancy, possible pregnancy that without using effective contraception.
- Patients who have serious concomitant illness that might be aggravated by chemotherapy, as below included:Active cardiac disease (e.g. congestive heart failure, angina, arrhythmia, acute myocardial disease or other types of heart disease requiring treatment) within 6 months period preceding entry into the study; Uncontrolled infection (e.g. active infection that uncontrolled for 2 weeks under antibiotic therapy); Retention of body fluid (e.g. pleural effusion, ascites, pericardial effusion, and edema needing treatment); History of other than esophageal cancer, except curatively treated non-melanoma skin cancer or in situ carcinoma of the esophagus; and other conditions which will be judged by physician's discretion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Induction Chemotherapy DCF followed by Surgery
All eligible patients will receive ND-420, Cisplatin and fluorouracil every 3 weeks for 2 cycles.
After induction chemotherapy, patients will be planned to receive Surgery.
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ND-420 50 mg/m2 on day1
Other Names:
After induction chemotherapy, participants will be receive right or left thoracotomy for curative resection by total or subtotal thoracic esophagectomy.
cisplatin 70 mg/m2 on day1
fluorouracil 700 mg/m2 daily, day1 to day4
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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the R0 resection rate of participants
Time Frame: up to three months
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up to three months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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the response rate (RECIST) of participants
Time Frame: up to three months
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up to three months
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Number of participants with adverse events as a measure of safety and tolerability
Time Frame: up to one year
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up to one year
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the population pharmacokinetic parameters (Cmax, AUC... )of ND-420 in the participants
Time Frame: 0, 30min, 1hr of ND-420 infusion. selected randomly form one of 3hr, 7hr, 11hr and 23hr after the end of ND-420 infusion.
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0, 30min, 1hr of ND-420 infusion. selected randomly form one of 3hr, 7hr, 11hr and 23hr after the end of ND-420 infusion.
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the correlation between clinical outcomes and the potential predictive genomic biomarkers(B-tubulin mutation, p53-Arg 72Pro, Bcl2-C938A, MDR1-C3435T polymorphism, TNFRSF1B-1466, GSTP1-l105V, CYP1B1, TS-5'UTR) for tumor response
Time Frame: up to one year
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up to one year
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1-year survival rate of participants
Time Frame: up to one year
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up to one year
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pathologic complete response rate of participants
Time Frame: up to one year
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up to one year
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1-year progression free survival rate of participants
Time Frame: up to one year
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up to one year
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1-year overall survival rate of participants
Time Frame: up to one year
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up to one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ming-Huang Chen, M.D., Taipei Veterans General Hospital, Taiwan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
December 2, 2014
Study Completion (Actual)
April 4, 2015
Study Registration Dates
First Submitted
December 9, 2013
First Submitted That Met QC Criteria
December 16, 2013
First Posted (Estimate)
December 23, 2013
Study Record Updates
Last Update Posted (Actual)
May 20, 2020
Last Update Submitted That Met QC Criteria
May 18, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Neoplasms
- Esophageal Squamous Cell Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Cisplatin
- Fluorouracil
Other Study ID Numbers
- NKCND420/201112
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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