NCT02033538

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

Enrollment Period

1.9 years

First QC Date

December 16, 2013

Last Update Submit

March 4, 2015

Conditions

Squamous Cell Carcinoma of Esophagus

Keywords

Neoadjuvant chemotherapyNab-PaclitaxelCarcinoma of Esophagus

Outcome Measures

Primary Outcomes (1)

  • response rate

    pathological response rate and clinical response rate

    From date of treatment until the date of progression, assessed up to 2 months

Secondary Outcomes (3)

  • Overall survival

    Overall survival was measured from the date of treatment to the date of death, or last follow-up,assessed up to 48 months

  • Progression-free survival

    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

  • Adverse events

    During the chemotherapy,an expected average of 3 weeks

Study Arms (1)

nanoparticle albumin-bound paclitaxel

EXPERIMENTAL

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

Interventions

nanoparticle albumin-bound paclitaxelDRUG

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle

Also known as: nab-paclitaxel
nanoparticle albumin-bound paclitaxel

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell CarcinomaEsophageal Neoplasms

Interventions

Taxes130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

EconomicsHealth Care Economics and Organizations

Study Officials

  • Qiong Zhao, MD

    The First Affiliated Hospital, Zhejiang University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department of Thoracic Oncology

Study Record Dates

First Submitted

December 16, 2013

First Posted

January 10, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

March 5, 2015

Record last verified: 2015-03

Locations

CN(1)