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

Esophagus Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03002064
• Other study ID #: SYSUCC-ESO-01
• Status: Recruiting
• Phase: Phase 3
• First received: December 16, 2016
• Last updated: December 23, 2016
• Start date: December 2016
• Est. completion date: December 2020

Study information

• Verified date: December 2016
• Source: Sun Yat-sen University
• Contact: Rui-Hua Xu, MD, PhD
• Phone: 86-020-87343333
• Email: xurh[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 358
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy Effects
• Esophageal Neoplasms
• Esophagus Cancer

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Cancer center of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	36 months	No
Secondary	Overall survival	From the date of randomization until the date of death from any cause.	36 months	No
Secondary	Response rate	Including complete response and partial response	36 months	No
Secondary	Grade 3 and 4 toxicities	According to the CTCAE	36 months	Yes
Secondary	Quality of life--Score of the questionnaire	EORTC QLQ-C30 and QLQ-OES18 questionnaire.	36 months	No