Trial of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Cancer

February 6, 2017 updated by: Tianjin Medical University Cancer Institute and Hospital

A Phase I/II Trial of Weekly Regimens of Nab-paclitaxel Plus Cispaltin Combined With Concurrent IMRT for Inoperable,Locally Advanced Esophageal Carcinoma

This trial is going to evaluate the efficacy and safety of IMRT / nab-TP chemotherapy for unresectable esophageal cancer, and to investigate the optimal concurrent chemotherapy regimen for local advanced and unresectable esophageal cancer patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Esophageal carcinoma is the sixth leading cause of cancer-related mortality from cancer with 407000 deaths and the eighth most common cancer worldwide. Concurrent chemoradiotherapy remains the mainstay of treatment for locally advanced esophageal cancer. Paclitaxel combined with radiotherapy was high efficiency and achieved encouraging results. Compared with paclitaxel, nab-paclitaxel has a low toxicity, low allergy and the tolerance is better than paclitaxel. According to the pre-clinical results, investigators designed a prospective study, which is combined nab-paclitaxel and cisplatin with concurrent chemoradiotherapy for the patients with locally advanced esophageal cancer, and evaluated the tolerability and efficacy. we design enrolled 30 patients, the end point included toxicity, progression-free survival and overall survival.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

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

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Department of Radiation Oncology, Tianjin Medical University Cancer Hospital
        • Contact:

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. inoperable locally advanced histologically confirmed esophageal cancer (T3N0M0-TxNxM1a（AJCC 2002)
  2. ECOG performance status scale 0-1
  3. at least 1 measurable target lesions
  4. white blood count ≥ 3,500/mm3, absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, hemoglobin count ≥ 90 g/dL, serum bilirubin level < 1.5 of the upper limit of normal (ULN) for the institution, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase ≤ 2.5 ULN, serum albumin ≥ 30g/L, serum creatinine ≤ 1.5 ULN; and
  5. normal cardiac function with no severe heart disease.

Exclusion Criteria:

  1. history of esophagectomy
  2. pregnancy or breast feeding
  3. past history of other cancers except for cured non-melanoma skin cancer or cervical cancer;
  4. concomitant treatment with other anticancer drugs.

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: nab-paclitaxel group
Weekly Regimens of paclitaxel Plus Cispaltin Combined With Concurrent IMRT
Drug: nab-paclitaxel group
Weekly Regimens of Nab-paclitaxel Plus Cispaltin Combined With Concurrent IMRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progress free survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years
3 years
CTCAE 4.0 toxicity
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Investigators

  • Principal Investigator: Ping Wang, M. D., Tianjin Medical University Cancer Hospital

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

July 1, 2014

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESO20140703

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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