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

Primary Purpose

Stage II and III Esophageal Squamous Cell Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
DCX
surgery
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage II and III Esophageal Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Sixth Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DCX and surgery

Arm Description

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

Outcomes

Primary Outcome Measures

overall survival rate

Secondary Outcome Measures

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

Full Information

First Posted
September 23, 2016
Last Updated
September 24, 2016
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02915965
Brief Title
A Trial of Neoadjuvant Chemotherapy for Stage II, III Esophageal Squamous Cell Carcinoma
Official Title
A Phase II Trial of Neoadjuvant Chemotherapy for Stage II, III Esophageal Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage II and III Esophageal Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DCX and surgery
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
DCX
Intervention Description
docetaxel, cisplatin and capecitabine
Intervention Type
Procedure
Intervention Name(s)
surgery
Intervention Description
Ivor Lewis Esophagectomy
Primary Outcome Measure Information:
Title
overall survival rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Pathologic response rate
Description
Pathologic response rate is defined as tumor regression score
Time Frame
2 years
Title
Disease-free survival
Time Frame
2 years
Title
Incidence of adverse event based on CTCAE 4.0
Description
Incidence of adverse event in patients during treatment period graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage II or III, which is potentially resectable. Patients must not have received any prior anticancer therapy. More than 6 months of expected survival. Age ranges from 18 to 70 years. 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. Karnofsky performance status (KPS) of 90 or more. Signed informed consent document on file. Exclusion Criteria: Patients are diagnosed or suspected to be allergic to docetaxol or cisplatin or capecitabine. Patients with concomitant hemorrhagic disease. Pregnant or breast feeding. Inability to use gastric conduit after esophagectomy because of a prior surgery. Patients with concomitant peripheral neuropathy, whose common toxicity criterion (CTC) status is 2 or even more. Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanhong Deng, MD PHD
Phone
+86020 38379762
Email
dengyanh@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jiayu Ling, MD
Phone
+86020 38379762
Email
lingjiay@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanhong Deng, MD PHD
Organizational Affiliation
Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Sixth Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China

12. IPD Sharing Statement

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

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