- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02033538
Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Squamous Cell Carcinoma of Esophagus
March 4, 2015 updated by: Qiong Zhao, Zhejiang University
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
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
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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Zhejiang
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Hangzhou, Zhejiang, China, 310003
- The First Affiliated Hospital, Zhejiang University
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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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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 |
---|---|
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
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
response rate
Time Frame: From date of treatment until the date of progression, assessed up to 2 months
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pathological response rate and clinical response rate
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From date of treatment until the date of progression, assessed up to 2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Overall survival was measured from the date of treatment to the date of death, or last follow-up,assessed up to 48 months
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|
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
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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
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Adverse events
Time Frame: During the chemotherapy,an expected average of 3 weeks
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Adverse events were classified according to U.S. National Cancer Institute common toxicity criteria, version 4.0
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During the chemotherapy,an expected average of 3 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Qiong Zhao, MD, The First Affiliated Hospital, Zhejiang University
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
January 1, 2014
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
December 16, 2013
First Submitted That Met QC Criteria
January 9, 2014
First Posted (Estimate)
January 10, 2014
Study Record Updates
Last Update Posted (Estimate)
March 5, 2015
Last Update Submitted That Met QC Criteria
March 4, 2015
Last Verified
March 1, 2015
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
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- ZYTOP1403
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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