A Trial of Neoadjuvant Chemotherapy for Stage II, III Esophageal Squamous Cell Carcinoma

September 24, 2016 updated by: Yanhong Deng, Sun Yat-sen University

A Phase II Trial of Neoadjuvant Chemotherapy for Stage II, III Esophageal Squamous Cell Carcinoma

The purpose of this study is to determine whether docetaxel, cisplatin, and capecitabine (DCX) are effective as the neoadjuvant chemotherapy before esophagectomy in patients with loco-regional esophageal squamous cell carcinoma (ESCC).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hospital of Sun Yat-sen University

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. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage II or III, which is potentially resectable.
  2. Patients must not have received any prior anticancer therapy.
  3. More than 6 months of expected survival.
  4. Age ranges from 18 to 70 years.
  5. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
  6. Karnofsky performance status (KPS) of 90 or more.
  7. Signed informed consent document on file.

Exclusion Criteria:

  1. Patients are diagnosed or suspected to be allergic to docetaxol or cisplatin or capecitabine.
  2. Patients with concomitant hemorrhagic disease.
  3. Pregnant or breast feeding.
  4. Inability to use gastric conduit after esophagectomy because of a prior surgery.
  5. Patients with concomitant peripheral neuropathy, whose common toxicity criterion (CTC) status is 2 or even more.
  6. Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.

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: DCX and surgery
docetaxol 60mg/m2 iv d1 and cisplatin 30mg/m2 iv d1-2 and capecitabine 850mg/m2 bid po d1-14 repeated every 21 days for 4-6 cycles, followed by surgery of Ivor Lewis Esophagectomy
Drug: DCX
docetaxel, cisplatin and capecitabine
Procedure: surgery
Ivor Lewis Esophagectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival rate
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 2 years
2 years
Pathologic response rate
Time Frame: 2 years
Pathologic response rate is defined as tumor regression score
2 years
Incidence of adverse event based on CTCAE 4.0
Time Frame: 2 years
Incidence of adverse event in patients during treatment period graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
2 years

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Yanhong Deng, MD PHD, Sixth Affiliated Hospital, Sun Yat-sen University

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

October 1, 2016

Primary Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

September 24, 2016

First Posted (Estimate)

September 27, 2016

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 24, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESCC01-SUMS6

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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