Clinical trial NCT03002064: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Esophagus Cancer
Chemotherapy Effects
Keywords: Esophagus squamous carcinoma
First-line chemotherapy
Docetaxel
Cisplatin
5-fluorouracil
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Progression free survival
timeFrame: 36 months
Secondary outcomes:
measure: Overall survival
timeFrame: 36 months
measure: Response rate
timeFrame: 36 months
measure: Grade 3 and 4 toxicities
timeFrame: 36 months
measure: Quality of life--Score of the questionnaire
timeFrame: 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer center of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Rui-Hua Xu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: