Docetaxol Plus Cisplatin Versus 5-Fu Plus Cisplatin as 1st-line Chemotherapy in Advanced ESCC Patients
NCT ID: NCT03002064
Last Updated: 2016-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
358 participants
INTERVENTIONAL
2016-12-31
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DP group
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.
Docetaxel
60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles.
Cisplatin
Cisplatin: 60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles
PF group
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.
Fluorouracil
5-fluorouracil 3750mg per square metre, civ 120 hours every 3 weeks till progression or at most 6 cycles
Cisplatin
Cisplatin: 60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles
Interventions
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Docetaxel
60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles.
Fluorouracil
5-fluorouracil 3750mg per square metre, civ 120 hours every 3 weeks till progression or at most 6 cycles
Cisplatin
Cisplatin: 60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Ruihua Xu
Professor
Principal Investigators
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Rui-Hua Xu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Cancer center of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Rui-Hua Xu, MD, PhD
Role: primary
Miao-Zhen Qiu, MD, PhD
Role: backup
Other Identifiers
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SYSUCC-ESO-01
Identifier Type: -
Identifier Source: org_study_id