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Docetaxol Plus Cisplatin Versus 5-Fu Plus Cisplatin as 1st-line Chemotherapy in Advanced ESCC Patients

Primary Purpose

Esophagus Cancer, Chemotherapy Effects

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Docetaxel
Fluorouracil
Cisplatin
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagus Cancer focused on measuring Esophagus squamous carcinoma, First-line chemotherapy, Docetaxel, Cisplatin, 5-fluorouracil

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients must give written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
  2. Patients must have histologically confirmed esophageal squamous cell carcinoma without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment. Patients were allowed to have palliative radiotherapy 3 months before the enrollment and the target lesions should not be within the radiotherapy region. The last date of adjuvant therapy should be over 6 months before the enrollment.
  3. With measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  4. With an expected life expectancy of ≥ 3 months.
  5. With a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  6. Without serious system dysfunction and could tolerate chemotherapy.
  7. Patients must have normal bone marrow function with a hemoglobin (HGB) of ≥90g/L, an white blood cell (WBC) counts of ≥4.0×10^9/L，a neutrophil count of ≥2.0×10^9/L, , a platelet count of ≥100×10^9/L.
  8. Patients must have normal liver and renal function with a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL), a creatinine (Cr) of ≤ 1.0 UNL, alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL.
  9. Patients must have normal electrocardiogram results and no history of congestive heart failure.
  10. Women of childbearing age should voluntarily take contraceptive measures. Without drug addition
  11. Patients must be with good compliance and agree to accept follow-up of disease progression and adverse events.

Exclusion Criteria:

  1. Allergic to known drug
  2. Patients who have received prior treatment including chemotherapy, radiotherapy and surgery for the advanced or metastatic diseases.
  3. Receive docetaxel within 6 months as adjuvant or neoadjuvant chemotherapy.
  4. Brain metastasis.
  5. Without measurable or evaluable disease.
  6. With history of other tumors except for those of cervical carcinoma in situ or skin basal cell carcinoma who had been completely treated and without relapse in last 5 years.
  7. With serious diseases such as congestive heart failure, uncontrolled myocardial infarction and arrhythmia, liver failure and renal failure.
  8. With neurological or psychiatric abnormalities that affect cognitive.
  9. Pregnant or lactated women (premenopausal women must give urine pregnancy test before enrollment)

Sites / Locations

  • Cancer center of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DP group

PF group

Arm Description

Docetaxel plus cisplatin. Docetaxel: 60mg per square metre on day 1 and Cisplatin: 60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles.

Cisplatin plus 5-fluorouracil. Cisplatin: 60mg per square metre on day 1 and 5-fluorouracil 3750mg per square metre, civ 120 hours every 3 weeks till progression or at most 6 cycles.

Outcomes

Primary Outcome Measures

Progression free survival
From the date of randomization until the date of first documented relapse of disease or date of death from any cause, whichever came first

Secondary Outcome Measures

Overall survival
From the date of randomization until the date of death from any cause.
Response rate
Including complete response and partial response
Grade 3 and 4 toxicities
According to the CTCAE
Quality of life--Score of the questionnaire
EORTC QLQ-C30 and QLQ-OES18 questionnaire.

Full Information

First Posted
December 16, 2016
Last Updated
December 23, 2016
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03002064
Brief Title
Docetaxol Plus Cisplatin Versus 5-Fu Plus Cisplatin as 1st-line Chemotherapy in Advanced ESCC Patients
Official Title
Docetaxel Plus Cisplatin Versus 5-fluorouracil Plus Cisplatin as First-line Treatment for Metastatic Esophageal Squamous Patients: a Prospective Multicenter, Randomized Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a phase III clinical trial to compare the efficacy of docetaxel plus cisplatin versus 5-Fu plus cisplatin in the first line chemotherapy for advanced or metastatic esophageal squamous carcinoma patients.
Detailed Description
Esophageal cancer is the 6th most common cause of cancer deaths worldwide and it is an endemic in many parts of the world, particularly in the developing countries, including China. Histologically, esophageal cancer can be classified as adenocarcinoma and esophageal squamous cell. carcinoma (ESCC) which is the most common histology in Asia. For locally advanced or metastatic ESCC patients, chemotherapy can improve overall survival (OS) and progression free survival (PFS). There is no standard first-line chemotherapy for ESCC patients. Cisplatin (DDP) plus fluorouracil is the most common used combination with a response rate of 25-35%. Previous studies showed that the combination of paclitaxel with cisplatin had good tolerance and efficacy to esophageal carcinoma. This is a prospective randomized control phase III clinical trial to compare the efficacy and safety between docetaxel/cisplatin and 5-Fu/cisplatin as the 1st line treatment in advanced or metastatic esophageal carcinoma patients. Sample size: This is a non-inferior study. The planned sample size was 358 patients, allowing for a 10% dropout rate and assuming the median progression free survival was 5.5 months in the experimental group and 4 months in the control group with a hazard ratio of 0.727, α=0.05, β=0.2. The planned enrolled time was 36 months and 12 months of follow up. The ratio between control and experimental group is 1:1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Cancer, Chemotherapy Effects
Keywords
Esophagus squamous carcinoma, First-line chemotherapy, Docetaxel, Cisplatin, 5-fluorouracil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
358 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DP group
Arm Type
Experimental
Arm Description
Docetaxel plus cisplatin. Docetaxel: 60mg per square metre on day 1 and Cisplatin: 60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles.
Arm Title
PF group
Arm Type
Active Comparator
Arm Description
Cisplatin plus 5-fluorouracil. Cisplatin: 60mg per square metre on day 1 and 5-fluorouracil 3750mg per square metre, civ 120 hours every 3 weeks till progression or at most 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Docetaxol
Intervention Description
60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Other Intervention Name(s)
5-Fu
Intervention Description
5-fluorouracil 3750mg per square metre, civ 120 hours every 3 weeks till progression or at most 6 cycles
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
DDP
Intervention Description
Cisplatin: 60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles
Primary Outcome Measure Information:
Title
Progression free survival
Description
From the date of randomization until the date of first documented relapse of disease or date of death from any cause, whichever came first
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
From the date of randomization until the date of death from any cause.
Time Frame
36 months
Title
Response rate
Description
Including complete response and partial response
Time Frame
36 months
Title
Grade 3 and 4 toxicities
Description
According to the CTCAE
Time Frame
36 months
Title
Quality of life--Score of the questionnaire
Description
EORTC QLQ-C30 and QLQ-OES18 questionnaire.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must give written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors. Patients must have histologically confirmed esophageal squamous cell carcinoma without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment. Patients were allowed to have palliative radiotherapy 3 months before the enrollment and the target lesions should not be within the radiotherapy region. The last date of adjuvant therapy should be over 6 months before the enrollment. With measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. With an expected life expectancy of ≥ 3 months. With a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale. Without serious system dysfunction and could tolerate chemotherapy. Patients must have normal bone marrow function with a hemoglobin (HGB) of ≥90g/L, an white blood cell (WBC) counts of ≥4.0×10^9/L，a neutrophil count of ≥2.0×10^9/L, , a platelet count of ≥100×10^9/L. Patients must have normal liver and renal function with a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL), a creatinine (Cr) of ≤ 1.0 UNL, alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL. Patients must have normal electrocardiogram results and no history of congestive heart failure. Women of childbearing age should voluntarily take contraceptive measures. Without drug addition Patients must be with good compliance and agree to accept follow-up of disease progression and adverse events. Exclusion Criteria: Allergic to known drug Patients who have received prior treatment including chemotherapy, radiotherapy and surgery for the advanced or metastatic diseases. Receive docetaxel within 6 months as adjuvant or neoadjuvant chemotherapy. Brain metastasis. Without measurable or evaluable disease. With history of other tumors except for those of cervical carcinoma in situ or skin basal cell carcinoma who had been completely treated and without relapse in last 5 years. With serious diseases such as congestive heart failure, uncontrolled myocardial infarction and arrhythmia, liver failure and renal failure. With neurological or psychiatric abnormalities that affect cognitive. Pregnant or lactated women (premenopausal women must give urine pregnancy test before enrollment)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rui-Hua Xu, MD, PhD
Phone
86-020-87343333
Email
xurh@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Miao-Zhen Qiu, MD, PhD
Phone
86-020-87342490
Email
qiumzh@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui-Hua Xu, MD, PhD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer center of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rui-Hua Xu, MD, PhD
Phone
86-020-87343333
Email
xurh@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Miao-Zhen Qiu, MD, PhD
Phone
86-020-87342490
Email
qiumzh@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Miao-zhen Qiu, MD
First Name & Middle Initial & Last Name & Degree
Rui-hua Xu, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Docetaxol Plus Cisplatin Versus 5-Fu Plus Cisplatin as 1st-line Chemotherapy in Advanced ESCC Patients

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