Back to resultsNeoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Squamous Cell Carcinoma of Esophagus
Primary Purpose
Squamous Cell Carcinoma of Esophagus
Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
nanoparticle albumin-bound paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of Esophagus focused on measuring Neoadjuvant chemotherapy, Nab-Paclitaxel, Carcinoma of Esophagus
Eligibility 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
Sites / Locations
- The first affiliated hospital, Zhejiang University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nanoparticle albumin-bound paclitaxel
Arm Description
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
Outcomes
Primary Outcome Measures
response rate
pathological response rate and clinical response rate
Secondary Outcome Measures
Overall survival
Progression-free survival
Adverse events
Adverse events were classified according to U.S. National Cancer Institute common toxicity criteria, version 4.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02033538
Brief Title
Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Squamous Cell Carcinoma of Esophagus
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 Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Why Stopped
This clinical trial was closed due to slow recruitment of patients.
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Esophagus
Keywords
Neoadjuvant chemotherapy, Nab-Paclitaxel, Carcinoma of Esophagus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nanoparticle albumin-bound paclitaxel
Arm Type
Experimental
Arm Description
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
Intervention Type
Drug
Intervention Name(s)
nanoparticle albumin-bound paclitaxel
Other Intervention Name(s)
nab-paclitaxel
Intervention Description
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
Primary Outcome Measure Information:
Title
response rate
Description
pathological response rate and clinical response rate
Time Frame
From date of treatment until the date of progression, assessed up to 2 months
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Adverse events
Description
Adverse events were classified according to U.S. National Cancer Institute common toxicity criteria, version 4.0
Time Frame
During the chemotherapy,an expected average of 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiong Zhao, MD
Organizational Affiliation
The First Affiliated Hospital, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Squamous Cell Carcinoma of Esophagus
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