NCT01258192

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of neoadjuvant chemotherapy with nab-paclitaxel plus cisplatin for stage Ⅱ-Ⅲ esophageal squamous cell carcinoma patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

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 3, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 10, 2010

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

July 29, 2014

Status Verified

July 1, 2014

Enrollment Period

1.8 years

First QC Date

December 3, 2010

Last Update Submit

July 28, 2014

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

esophageal squamous cell carcinomaneoadjuvant chemotherapyalbumin-bound paclitaxelcisplatin

Outcome Measures

Primary Outcomes (1)

  • response to induction therapy

    The response to induction therapy will be evaluated

    2 years

Secondary Outcomes (4)

  • rate of complete pathological response

    2 years

  • R0 resection rate.

    2 years

  • 3 years disease free and overall survival

    5 years

  • safety and tolerability

    From time of consent to last visit

Study Arms (1)

nab-paclitaxel plus cisplatin

EXPERIMENTAL
Drug: albumin-bound paclitaxel plus cisplatin

Interventions

albumin-bound paclitaxel plus cisplatinDRUG

neo-chemotherapy program:Albumin-bound paclitaxel:100 mg/m2, IV (in the vein) on days 1,8 of each 21 day cycle. Cisplatin 75mg/m2,IV DRIP on day 1 of each 21 day cycle.Number of Cycles: 2 cycles before operation.If it is effective ,2 cycles will be given in 6 weeks after radical resection.

Also known as: nab-paclitaxel
nab-paclitaxel plus cisplatin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic diagnosis of squamous cell carcinoma of esophagus. Preoperative stage Ⅱ-Ⅲ by endoscopic ultrasound, CT of the chest and abdomen,and esophagogram.
  • Age ranges from 18 to 70 years.
  • Patients must not have received any prior anticancer therapy.
  • Performance status of 0 to 1
  • Estimated life expectancy of at least 6 months.
  • Tumor can be measured according to RECIST criteria
  • Signed informed consent document on file.
  • Females with childbearing potential must have a negative serum pregnancy
  • Adequate organ function including the following:
  • Bone marrow: Absolute neutrophil count (ANC) greater than or equal 1.5×109/L Platelets greater than or equal 80×109/L Haemoglobin greater than or equal 80g/L Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN), Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN Renal: calculated creatinine clearance rate≥60ml/min. test within 7 days prior to study enrollment.

You may not qualify if:

  • Carcinoma at the upper part of esophagus
  • Histologic diagnosis of adenocarcinoma of esophagus.
  • Prior treatment for esophageal cancer.
  • Active infection.
  • Pregnant or breast feeding.
  • History of significant neurological or mental disorder, including seizures or dementia.
  • Prior invasive malignancy in 5 years (except for carcinoma in situ).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (1)

  • Fan Y, Jiang Y, Zhou X, Chen Q, Huang Z, Xu Y, Gong L, Yu H, Yang H, Liu J, Lei T, Zhao Q, Mao W. Phase II study of neoadjuvant therapy with nab-paclitaxel and cisplatin followed by surgery in patients with locally advanced esophageal squamous cell carcinoma. Oncotarget. 2016 Aug 2;7(31):50624-50634. doi: 10.18632/oncotarget.9562.

    PMID: 27244882DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Albumin-Bound PaclitaxelCisplatin130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Weimin Mao, MD

    Zhejiang Cancer Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2010

First Posted

December 10, 2010

Study Start

January 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

July 29, 2014

Record last verified: 2014-07

Locations

CN(1)