Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03002064
Recruitment Status : Recruiting
First Posted : December 23, 2016
Last Update Posted : December 26, 2016
Sponsor:
Information provided by (Responsible Party):
Ruihua Xu, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Esophagus Cancer Chemotherapy Effects Drug: Docetaxel Drug: Fluorouracil Drug: Cisplatin Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Docetaxel
60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles.
Other Name: Docetaxol

Drug: Cisplatin
Cisplatin: 60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles
Other Name: DDP

Active Comparator: 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.
Drug: Fluorouracil
5-fluorouracil 3750mg per square metre, civ 120 hours every 3 weeks till progression or at most 6 cycles
Other Name: 5-Fu

Drug: Cisplatin
Cisplatin: 60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles
Other Name: DDP




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 36 months ]
    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 :
  1. Overall survival [ Time Frame: 36 months ]
    From the date of randomization until the date of death from any cause.

  2. Response rate [ Time Frame: 36 months ]
    Including complete response and partial response

  3. Grade 3 and 4 toxicities [ Time Frame: 36 months ]
    According to the CTCAE

  4. Quality of life--Score of the questionnaire [ Time Frame: 36 months ]
    EORTC QLQ-C30 and QLQ-OES18 questionnaire.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002064


Contacts
Layout table for location contacts
Contact: Rui-Hua Xu, MD, PhD 86-020-87343333 xurh@sysucc.org.cn
Contact: Miao-Zhen Qiu, MD, PhD 86-020-87342490 qiumzh@sysucc.org.cn

Locations
Layout table for location information
China, Guangdong
Cancer center of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Rui-Hua Xu, MD, PhD    86-020-87343333    xurh@sysucc.org.cn   
Contact: Miao-Zhen Qiu, MD, PhD    86-020-87342490    qiumzh@sysucc.org.cn   
Sub-Investigator: Miao-zhen Qiu, MD         
Principal Investigator: Rui-hua Xu, MD, PhD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Layout table for investigator information
Principal Investigator: Rui-Hua Xu, MD, PhD Sun Yat-sen University

Layout table for additonal information
Responsible Party: Ruihua Xu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03002064     History of Changes
Other Study ID Numbers: SYSUCC-ESO-01
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: December 26, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ruihua Xu, Sun Yat-sen University:
Esophagus squamous carcinoma
First-line chemotherapy
Docetaxel
Cisplatin
5-fluorouracil
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Docetaxel
Fluorouracil
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs