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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

An Open, Multicenter, Randomized Phase III Clinical Study on Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02677597
• Other study ID #: CISPEC study
• Status: Recruiting
• Phase: Phase 3
• First received: February 5, 2016
• Last updated: February 8, 2016
• Start date: January 2016
• Est. completion date: January 2019

Study information

• Verified date: February 2016
• Source: Fudan University
• Contact: Chang J Hua, PD
• Phone: 13916619284
• Email: changjianhua[@]163.com
• Is FDA regulated: No
• Health authority: China: Fudan University Cancer Center IRB (Institutional Review Board)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Cisplatin Combined With S-1

• Cisplatin Combined With Paclitaxel

Locations

Country	Name	City	State
China	Cancer hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS		Since the date of random to disease progression or any cause of death,the average time is 2 years	Yes