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Neoadjuvant Therapy With Nab-paclitaxel and Cisplatin for Locally Advanced Esophageal Squamous Cell Carcinoma (NTNC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964753
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
LiuJunFeng, Hebei Medical University Fourth Hospital

Brief Summary:
To verify the role of nab-paclitaxel in neoadjuvant therapy for esophageal squamous cell carcinoma, the investigators designed a prospective, randomized, controlled , multicente phase II trial, to investigate the efficacy and safety of nab-paclitaxel combined with cisplatin as neoadjuvant therapy followed by surgery versus surgery alone for esophageal squamous cell carcinoma.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: Nab-paclitaxel and Cisplatin Procedure: surgery Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness and Safety of Neoadjuvant Therapy With Nab-paclitaxel and Cisplatin Followed by Surgery Versus Surgery Alone for Locally Advanced Esophageal Squamous Cell Carcinoma
Actual Study Start Date : April 24, 2019
Estimated Primary Completion Date : June 24, 2026
Estimated Study Completion Date : December 24, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neo-adjuvant chemotherapy group

cisplatin and nab-paclitaxel: Nab-paclitaxel, 125mg/m(2), d1,d8, Cisplatin, 75mg/m(2), d1, 3 week, 2 cycles.

Surgery:

4-6weeks after Neo-adjuvant chemotherapy

Drug: Nab-paclitaxel and Cisplatin
Nab-paclitaxel,125mg/m(2), d1,d8, Cisplatin,75mg/m(2), d1, 3 week, 2 cycles.

Procedure: surgery
surgery

Active Comparator: Surgery alone
Surgery alone
Procedure: surgery
surgery




Primary Outcome Measures :
  1. OS [ Time Frame: up to 5 years ]
    Overall survival,From date of randomization until death due to any cause


Secondary Outcome Measures :
  1. OS rate [ Time Frame: 1 year,3years,5years ]
    Overall survival rate

  2. DFS rate [ Time Frame: 1 year,3years,5years ]
    Disease free survival rate

  3. R0 resection rate [ Time Frame: within 4 weeks following the operation ]
    R0 resection rate

  4. Down-staging rate [ Time Frame: within 6 weeks following the last dose of chemotherapy ]
    Down-staging rate

  5. Rate of Operative Complications [ Time Frame: within 4 weeks following the operation ]
  6. Rate of Adverse Event [ Time Frame: up to 6 weeks after the last dose of chemotherapy ]
    Incidence of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Age ranges from 18 to 75 years
  • Radiographically, histologically or/and cytologically diagnosed resectable locally advanced middle-lower esophageal squamous cell carcinoma without distant metastasis,cT1N1M0 or T2-3N0-1M0(according to UICC esophageal cancer TNM staging system 8th edition)
  • Enhanced CT showed the presence of potentially resectable lesions. Resectability features included no evidence of mediastinal infiltration, No evidence of tracheobronchial fistula or tumor entry into the airway
  • Have not previously received systemic antitumor therapy for esophageal squamous cell carcinoma (Including radiotherapy, chemotherapy, targeted therapy, immunotherapy)
  • ECOG performance status 0-1
  • Expected survival more than 6 months
  • No contraindications in the organ function tests before surgery
  • The laboratory test meet the following requirements:

Bone marrow function: neutrophils ≥ 1.5×10(9)/L, platelets ≥ 100×10(9)/L, hemoglobin ≥ 90 g/L Liver function:Total bilirubin ≤ 1.5x ULN;AST and ALT) ≤ 2.5x ULN Renal function:Cr ≤ 1.5x ULN,Ccr ≥ 55 ml/min Coagulation function:INR≤1.5×ULN, PT≤1.5ULN, APTT within the normal range

  • Female patients of child-bearing age agree to take effective contraceptive measures during the study period and 6 months after reseach completion;Pregnancy tests in serum or urine must be negative 7 days prior to study enrollment;Non-lactating patients;male patients agree to take effective contraceptive measures during the study period and 6 months after reseach completion
  • Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver)
  • Not participating in other clinical trials 4 weeks before the treatment
  • The patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form.

Exclusion Criteria:

  • Histological confirmation of esophageal adenocarcinoma
  • with distant metastasis, without radical resection (stage IV)
  • Ever administrated with other drugs(including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after recruitment
  • Grade 2 or above peripheral neuropathy or hemorrhage according to NCI CTCAE 4.03
  • Combined with severe cardiovascular disease, including hypertension that cannot be controlled by medical treatment(BP≥160/95mmHg), unstable angina, a history of myocardial infarction in the past 6 months,Congestive heart failure>NYHA grade II, severe arrhythmia, pericardial effusion, etc.
  • Combined with severe ADH abnormal secretion syndrome, poorly controlled diabetes: more than 40 units of insulin per day need to be continuously administered; or 40 units of insulin per day for continuous use or not used, but fasting blood glucose is still above 14mmol / L, HbA1c above 9.0
  • Long-term use of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues for more than 6 months,small doses of warfarin (≤1mg / day) or aspirin (≤100mg / day) for prevention purposes are not included
  • Major surgery within 4 weeks prior to enrollment, or surgical wounds have not fully healed
  • Operation can not use the stomach instead of esophageal cancer to reconstruct the digestive tract due to previous operation
  • Severe infection within 1 week prior to the start of study, requiring intravenous antibiotics, antifungal or antiviral therapy
  • Known to be allergic, highly sensitive or intolerable to research-related drugs or excipient
  • In the past 5 years, there were other malignant tumors, melanoma skin cancer or ervical carcinoma in situ were excepted
  • Any indicator shows chemotherapy and surgery contraindications
  • Women who are pregnant or lactating
  • The investigator determined that unable to complete the study due to medical, social, or psychological reasons or were unable to sign valid informed consent

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): NCT03964753


Contacts
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Contact: Junfeng Liu, PhD 13931152296 liujf@hbmu.edu

Locations
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China, Hebei
Jun Feng Liu Recruiting
Shijiazhuang, Hebei, China, 050011
Contact: Jun Feng Liu, PhD    13931152296      
Sponsors and Collaborators
Hebei Medical University Fourth Hospital
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Responsible Party: LiuJunFeng, Director of thoracic surgery, Hebei Medical University Fourth Hospital
ClinicalTrials.gov Identifier: NCT03964753    
Other Study ID Numbers: HebeiJLiu
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Cisplatin
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action