NCT01998347

Brief Summary

There are no standard chemotherapy regimens for metastatic esophageal cancer. Cisplatin plus 5-fluorouracil is widely used as first-line treatment with a response rate ranged from 30% to 40%. Combination of paclitaxel and cisplatin has been investigated in small size clinical trial, producing promising outcome.Liposome capsuled paclitaxel has been proved to be as effective as paclitaxel.The usefulness of the the regimen of paclitaxel liposome with cisplatin is evaluated by median survival time, progression free survival,and response rate.

Trial Health

35
At Risk

Trial Health Score

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

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withdrawn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

Study Start

First participant enrolled

November 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

4.1 years

First QC Date

November 17, 2013

Last Update Submit

November 18, 2015

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • median overall survival

    one year

Secondary Outcomes (1)

  • median progression free survival

    6 months

Other Outcomes (1)

  • time to progression

    6 months

Study Arms (2)

Paclitaxel liposome and Cisplatin

EXPERIMENTAL

Drug: paclitaxel liposome 175mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles:up to 6 cycles. Drug: cisplatin 37.5 mg/m2, IV (in the vein) on day 1\~2 of each 21 day cycle. Number of Cycles: up to 6 cycles.

Drug: Paclitaxel liposomeDrug: Cisplatin

Cisplatin plus 5-fluorouracil

ACTIVE COMPARATOR

Cisplatin: 37.5 mg/m2, IV (in the vein) on day 1-2 of each 21 day cycle. Number of Cycles: up to 6 cycles. 5-fluorouracil: 200mg/m2, CIV (continuous intravenous infusion) on day 1\~5 of each 21 day cycle. Number of Cycles: up to 6 cycles.

Drug: CisplatinDrug: 5-fluorouracil

Interventions

Paclitaxel liposomeDRUG
Paclitaxel liposome and Cisplatin
CisplatinDRUG
Cisplatin plus 5-fluorouracilPaclitaxel liposome and Cisplatin
5-fluorouracilDRUG
Cisplatin plus 5-fluorouracil

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed metastatic esophageal tumors with no previous treatment for advanced disease or recurrent disease after previous treatment for at least one year.
  • At least one measurable lesion according to the RECIST1.1 (Response Evaluation Criteria in Solid Tumors RECIST Version 1.1) criteria. Minimum indicator lesion size: \> 10 mm measured by spiral CT or \>20mm measured by conventional techniques.
  • Patients aged between 18 and 70 years, inclusive, at the time of acquisition of informed consent
  • Patients with performance status(ECOG) 0 to 1.
  • Abnormal hematologic values (WBC ≥ 3.0 x 109/L, Hemoglobin ≥ 10.0g/dl, platelet count ≥ 100 x 109/L)
  • Creatinine clearance ≥ 60 ml/min, Serum creatinine ≤ 1.5mg/dl
  • Serum bilirubin ≤ 1.5mg/dl. ALT(Alanine transaminase ), AST(Aspartate Transaminase) ≤ 2.5 x upper normal limit (or ≤ 2.5 x upper normal limit in the case of liver metastases)
  • Life expectancy ≥ 3 months
  • Patients who have given written informed consent to participate in this study

You may not qualify if:

  • Patients with active multiple cancers; or even if the multiple cancers are metachronous, have a disease-free period of less than 5 years (but excluding cancer in situ and skin cancer)
  • Serious, uncontrolled, concurrent infection(s) or illness(es)
  • Patients with no serious concurrent complications (such as heart disease, Intestinal pneumonia)
  • Patients with brain metastasis
  • Patients receiving continuous administration of steroids
  • Patients who have experienced serious drug allergy in the past
  • Patients with retention of body fluid(pleural effusion, ascites, pericardial effusion) necessitating treatment
  • Patients who are pregnant and lactating or hope to become pregnant during the study period
  • Patients with prior Taxane treatment (Paclitaxel)
  • Others, patients judged by the investigator or coinvestigator to be inappropriate as subject

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of medical oncology,Cancer hospital of Shantou University Medical colledge

Shantou, Guangdong, 515031, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

CisplatinFluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
deputy secretary

Study Record Dates

First Submitted

November 17, 2013

First Posted

November 28, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2017

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

CN(1)