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

NCT ID: NCT02677597

Last Updated: 2016-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-01-31

Brief Summary

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

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Cisplatin Combined With S-1

Intervention Type: DRUG

Cisplatin Combined With Paclitaxel

Cisplatin 75mg/m2 ivgtt d1 Paclitaxel 175mg/m2 d1 ivgtt 3h

Group Type: EXPERIMENTAL

Cisplatin Combined With Paclitaxel

Intervention Type: DRUG

Interventions

Cisplatin Combined With S-1

Intervention Type: DRUG

Cisplatin Combined With Paclitaxel

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Chang Jian Hua

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chang J Hua, PD

Role: CONTACT

changjianhua@163.com

13916619284

Facility Contacts

Chang J hua, PD

Role: primary

changjianhua@163.com

13916619284

Other Identifiers

CISPEC study

Identifier Type: -

Identifier Source: org_study_id