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

Fudan University

Status and phase: Unknown; Phase 3

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Drug: Cisplatin Combined With Paclitaxel; Drug: Cisplatin Combined With S-1

Study type: Interventional

Funder types: Other

Identifiers

NCT02677597

CISPEC study

Details and patient eligibility

About

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

Enrollment: 268 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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268 participants in 2 patient groups

Cisplatin Combined With S-1

Experimental group

Description:

Cisplatin 75mg/m2 ivgtt d1 S-1 BSA\<1.5 50mg bid，BSA≥1.5 60mg bid po d1-14

Treatment:

Drug: Cisplatin Combined With S-1

Cisplatin Combined With Paclitaxel

Experimental group

Description:

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

Treatment:

Drug: Cisplatin Combined With Paclitaxel