Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
Primary Purpose
Esophageal Squamous Cell Carcinoma
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Cisplatin Combined With S-1
Cisplatin Combined With Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Histologically proven primary thoracic esophageal squamous cell carcinoma
- Not suitable for surgery or radio or chemical therapy
- Presence of at least one index lesion measurable by CT scan or MRI radiation therapy ended at least 4 weeks, but part of the radiation does not as a measurable lesions
- 18~70 years
- PS:0-1
- Life expectancy of ≥ 3 months
- WBC≥3.5×109/L,ANC≥1.5×109/L, PLT≥100×109/L, Hb≥100g/L
- TB ≤ 1.5UNL, ALT/AST ≤ 2.5×UNL
- Scr≥60 mL/min
- Normal electrocardiogram (ecg)
- Can normal oral drugs
- Signed written informed consent
Exclusion Criteria:
- Breast-feeding or pregnant women, no effective contraception if risk of conception exists
- Chronic diarrhea, enteritis, intestine obstruction which are not under control
- Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc.
- A second primary tumor (except skin basal cell carcinoma)
- The original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension
- With uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or - CNS metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms
- With bleeding tendency
- Has inherited bleeding evidence of physical or blood coagulation disorder
- With clear chemotherapy drug allergy
- Other researchers believe that patients should not participate in this testing
Sites / Locations
- Cancer hospital Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cisplatin Combined With S-1
Cisplatin Combined With Paclitaxel
Arm Description
Cisplatin 75mg/m2 ivgtt d1 S-1 BSA<1.5 50mg bid,BSA≥1.5 60mg bid po d1-14
Cisplatin 75mg/m2 ivgtt d1 Paclitaxel 175mg/m2 d1 ivgtt 3h
Outcomes
Primary Outcome Measures
PFS
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02677597
Brief Title
Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
Official Title
An Open, Multicenter, Randomized Phase III Clinical Study on Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
268 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cisplatin Combined With S-1
Arm Type
Experimental
Arm Description
Cisplatin 75mg/m2 ivgtt d1 S-1 BSA<1.5 50mg bid,BSA≥1.5 60mg bid po d1-14
Arm Title
Cisplatin Combined With Paclitaxel
Arm Type
Experimental
Arm Description
Cisplatin 75mg/m2 ivgtt d1 Paclitaxel 175mg/m2 d1 ivgtt 3h
Intervention Type
Drug
Intervention Name(s)
Cisplatin Combined With S-1
Intervention Type
Drug
Intervention Name(s)
Cisplatin Combined With Paclitaxel
Primary Outcome Measure Information:
Title
PFS
Time Frame
Since the date of random to disease progression or any cause of death,the average time is 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:
Histologically proven primary thoracic esophageal squamous cell carcinoma
Not suitable for surgery or radio or chemical therapy
Presence of at least one index lesion measurable by CT scan or MRI radiation therapy ended at least 4 weeks, but part of the radiation does not as a measurable lesions
18~70 years
PS:0-1
Life expectancy of ≥ 3 months
WBC≥3.5×109/L,ANC≥1.5×109/L, PLT≥100×109/L, Hb≥100g/L
TB ≤ 1.5UNL, ALT/AST ≤ 2.5×UNL
Scr≥60 mL/min
Normal electrocardiogram (ecg)
Can normal oral drugs
Signed written informed consent
Exclusion Criteria:
Breast-feeding or pregnant women, no effective contraception if risk of conception exists
Chronic diarrhea, enteritis, intestine obstruction which are not under control
Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc.
A second primary tumor (except skin basal cell carcinoma)
The original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension
With uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or - CNS metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms
With bleeding tendency
Has inherited bleeding evidence of physical or blood coagulation disorder
With clear chemotherapy drug allergy
Other researchers believe that patients should not participate in this testing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chang J Hua, PD
Phone
13916619284
Email
changjianhua@163.com
Facility Information:
Facility Name
Cancer hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang J hua, PD
Phone
13916619284
Email
changjianhua@163.com
First Name & Middle Initial & Last Name & Degree
Chang J hua, PD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
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