Back to resultsTrial of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Cancer
Primary Purpose
Esophageal Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
nab-paclitaxel group
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring nab-paclitaxel, IMRT, esophageal cancer
Eligibility Criteria
Inclusion Criteria:
- inoperable locally advanced histologically confirmed esophageal cancer (T3N0M0-TxNxM1a（AJCC 2002)
- ECOG performance status scale 0-1
- at least 1 measurable target lesions
- 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
- normal cardiac function with no severe heart disease.
Exclusion Criteria:
- history of esophagectomy
- pregnancy or breast feeding
- past history of other cancers except for cured non-melanoma skin cancer or cervical cancer;
- concomitant treatment with other anticancer drugs.
Sites / Locations
- Department of Radiation Oncology, Tianjin Medical University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nab-paclitaxel group
Arm Description
Weekly Regimens of paclitaxel Plus Cispaltin Combined With Concurrent IMRT
Outcomes
Primary Outcome Measures
Progress free survival
Secondary Outcome Measures
Overall survival
CTCAE 4.0 toxicity
Full Information
NCT ID
NCT02762474
First Posted
May 3, 2016
Last Updated
February 6, 2017
Sponsor
Tianjin Medical University Cancer Institute and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02762474
Brief Title
Trial of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Cancer
Official Title
A Phase I/II Trial of Weekly Regimens of Nab-paclitaxel Plus Cispaltin Combined With Concurrent IMRT for Inoperable,Locally Advanced Esophageal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
nab-paclitaxel, IMRT, esophageal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nab-paclitaxel group
Arm Type
Experimental
Arm Description
Weekly Regimens of paclitaxel Plus Cispaltin Combined With Concurrent IMRT
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel group
Intervention Description
Weekly Regimens of Nab-paclitaxel Plus Cispaltin Combined With Concurrent IMRT
Primary Outcome Measure Information:
Title
Progress free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
3 years
Title
CTCAE 4.0 toxicity
Time Frame
6 months
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:
inoperable locally advanced histologically confirmed esophageal cancer (T3N0M0-TxNxM1a（AJCC 2002)
ECOG performance status scale 0-1
at least 1 measurable target lesions
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
normal cardiac function with no severe heart disease.
Exclusion Criteria:
history of esophagectomy
pregnancy or breast feeding
past history of other cancers except for cured non-melanoma skin cancer or cervical cancer;
concomitant treatment with other anticancer drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Wang, M. D.
Phone
0862223340123
Email
wangping@tjmuch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Wang, M. D.
Email
wangping@tjmuch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping Wang, M. D.
Organizational Affiliation
Tianjin Medical University Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiation Oncology, Tianjin Medical University Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Wang, M. D.
Phone
08623340123-1141
Email
wangping@tjmuch.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Trial of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Cancer
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