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Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Squamous Cell Carcinoma of Esophagus

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ClinicalTrials.gov Identifier: NCT02033538
Recruitment Status : Withdrawn (This clinical trial was closed due to slow recruitment of patients.)
First Posted : January 10, 2014
Last Update Posted : March 5, 2015
Sponsor:
Information provided by (Responsible Party):
Qiong Zhao, Zhejiang University

Brief Summary:
Albumin-bound paclitaxel regimen in advanced NSCLC has a better tumor response rate and safety than solvent-based paclitaxel. However, the safety and efficacy is uncertain in neoadjuvant therapy in esophageal cancer. The objective of this single-arm phase II trial was to evaluate the benefit of neoadjuvant chemotherapy with nanoparticle albumin-bound paclitaxel plus 5-fluorouracil in patients with locally advanced esophageal squamous cell carcinoma.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of Esophagus Drug: nanoparticle albumin-bound paclitaxel Phase 2

Detailed Description:
In the past decade, clinical trials have evaluated the role of neoadjuvant chemotherapy, radiation, or both, for patients with surgically resectable esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. In Eastern countries, preoperative chemotherapy followed by radical surgery became one of the treatment strategies for resectable, clinical stage II or III esophageal cancer. In an effort to improve the efficacy of systemic chemotherapy, we conducted a prospective study to evaluate the regimen of nanoparticle albumin-bound paclitaxel plus 5-fluorouracil as perioperative therapy for patients with resectable esophageal carcinoma.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Neoadjuvant Chemotherapy With Nanoparticle Albumin-bound Paclitaxel and Fluorouracil Followed by Surgery in Patients With Locally Advanced Squamous Cell Carcinoma of Esophagus
Study Start Date : January 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: nanoparticle albumin-bound paclitaxel
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
Drug: nanoparticle albumin-bound paclitaxel
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
Other Name: nab-paclitaxel




Primary Outcome Measures :
  1. response rate [ Time Frame: From date of treatment until the date of progression, assessed up to 2 months ]
    pathological response rate and clinical response rate


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Overall survival was measured from the date of treatment to the date of death, or last follow-up,assessed up to 48 months ]
  2. Progression-free survival [ Time Frame: Progression-free survival was measured from the date of treatment to the date of first evidence of relapse or death due to any cause,assessed up to 36 months ]
  3. Adverse events [ Time Frame: During the chemotherapy,an expected average of 3 weeks ]
    Adverse events were classified according to U.S. National Cancer Institute common toxicity criteria, version 4.0



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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:

  • Histologically confirmed squamous cell carcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I)
  • Locally advanced disease that is technically operable with curative intent (R0)
  • T3, N0 OR T1-3, N+ OR T4, Nx
  • No T1-2, N0
  • No inoperable T4 (unequivocal organ involvement)
  • No distant metastasis, including M1a lymph node status
  • Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology
  • No carcinoma of the cervical esophagus
  • Obstructive tumors allowed

Exclusion Criteria:

  • Not suitable to surgery
  • cervical Esophageal Carcinoma(distance of incisor tooth<19cm)
  • early Esophageal Carcinoma(Stage I)
  • complete esophageal obstruction,Esophageal perforation or hematemesis
  • other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
  • pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
  • Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
  • History of serious allergic or castor oil allergy
  • Patients who are not suitable to participate in the trial according to researchers

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): NCT02033538


Locations
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China, Zhejiang
The first affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Zhejiang University
Investigators
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Principal Investigator: Qiong Zhao, MD The First Affiliated Hospital, Zhejiang University

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Responsible Party: Qiong Zhao, Chief of Department of Thoracic Oncology, Zhejiang University
ClinicalTrials.gov Identifier: NCT02033538     History of Changes
Other Study ID Numbers: ZYTOP1403
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015
Keywords provided by Qiong Zhao, Zhejiang University:
Neoadjuvant chemotherapy
Nab-Paclitaxel
Carcinoma of Esophagus
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action