Esophageal Squamous Cell Carcinoma
Conditions
Brief summary
Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
Interventions
DRUGCisplatin Combined With S-1
DRUGCisplatin Combined With Paclitaxel
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS | Since the date of random to disease progression or any cause of death，the average time is 2 years |
Countries
China
Contacts
Primary ContactChang J Hua, PD
Outcome results
None listed