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

NCT03002064 | Unknown Phase 3

• 1 other identifier: SYSUCC-ESO-01
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophagus Cancer; Chemotherapy Effects

Keywords

Esophagus squamous carcinoma; First-line chemotherapy; Docetaxel; Cisplatin; 5-fluorouracil

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Overall survival

  36 months

• Response rate

  36 months

• Grade 3 and 4 toxicities

  36 months

• Quality of life--Score of the questionnaire

  36 months

Study Arms (2)

DP group

EXPERIMENTAL

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; Drug: Cisplatin

PF group

ACTIVE COMPARATOR

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; Drug: Cisplatin

Interventions

Docetaxel DRUG

60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles.

Also known as: Docetaxol

DP group

Fluorouracil DRUG

5-fluorouracil 3750mg per square metre, civ 120 hours every 3 weeks till progression or at most 6 cycles

Also known as: 5-Fu

PF group

Cisplatin DRUG

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

Also known as: DDP

DP group; PF group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer center of Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Docetaxel; Fluorouracil; Cisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Rui-Hua Xu, MD, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui-Hua Xu, MD, PhD

CONTACT

86-020-87343333; xurh@sysucc.org.cn

Miao-Zhen Qiu, MD, PhD

CONTACT

86-020-87342490; qiumzh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 23, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: December 26, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)