Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma

Phase 3

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Drug: Cisplatin Combined With S-1; Drug: Cisplatin Combined With Paclitaxel

• Registration Number: NCT02677597
• Lead Sponsor: Fudan University

Brief Summary

Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-02
• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-02-08
• Last Update Submitted: 2016-02-08
• Study First Posted: 2016-02-09
• Last Update Posted: 2016-02-09
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 268

Inclusion Criteria

• Histologically proven primary thoracic esophageal squamous cell carcinoma
• Not suitable for surgery or radio or chemical therapy
• Presence of at least one index lesion measurable by CT scan or MRI radiation therapy ended at least 4 weeks, but part of the radiation does not as a measurable lesions
• 18~70 years
• PS:0-1
• Life expectancy of ≥ 3 months
• WBC≥3.5×109/L,ANC≥1.5×109/L, PLT≥100×109/L, Hb≥100g/L
• TB ≤ 1.5UNL, ALT/AST ≤ 2.5×UNL
• Scr≥60 mL/min
• Normal electrocardiogram (ecg)
• Can normal oral drugs
• Signed written informed consent

Exclusion Criteria

• Breast-feeding or pregnant women, no effective contraception if risk of conception exists
• Chronic diarrhea, enteritis, intestine obstruction which are not under control
• Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc.
• A second primary tumor (except skin basal cell carcinoma)
• The original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension
• With uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or - CNS metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms
• With bleeding tendency
• Has inherited bleeding evidence of physical or blood coagulation disorder
• With clear chemotherapy drug allergy
• Other researchers believe that patients should not participate in this testing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cisplatin Combined With S-1	Cisplatin Combined With S-1	Cisplatin 75mg/m2 ivgtt d1 S-1 BSA\<1.5 50mg bid，BSA≥1.5 60mg bid po d1-14
Cisplatin Combined With Paclitaxel	Cisplatin Combined With Paclitaxel	Cisplatin 75mg/m2 ivgtt d1 Paclitaxel 175mg/m2 d1 ivgtt 3h

Primary Outcome Measures

Name	Time	Method
PFS	Since the date of random to disease progression or any cause of death，the average time is 2 years

Trial Locations

Locations (1)

Cancer hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China