Squamous Cell Carcinoma
Conditions
Keywords
Nedaplatin, lung squamous cell carcinoma
Brief summary
The treatment of squamous cell carcinoma of lung has not improved suffuciently. Nedaplatin is a second-generation platinum compound that is more active against squamous cell carcinoma of the lung with a response rate of 60%, issued by the finished Phase II trial in Japan.
Interventions
DRUGNedaplatin
DRUGCisplatin
DRUGDocetaxel
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. primary lung squamous carcinoma confirmed by cytology and histology, excluding sputum examination. 2. IIIB-no radiotherapy indication /IV phased by ASLC 2009 TNM criteria. 3. at least one measurable tumor based on RECIST ( longest diameter: ≥20 mm by CT scan or 10 mm by spiral CT ) 4. male or female, age≥18 or ≤75 years old 5. ECOG PS: 0 or 1 6. estimated time of survival: ≥12 weeks 7. suitable hematologic function: ANC≥2×109/L, PLC≥100×109/L and Hb≥9 g/dL 8. suitable liver function: Total bilirubin≤normal ULN, AST and ALT≤2.5×normal ULN, ALP≤5×normal ULN. 9. suitable renal function: Cr≤normal ULN,or Ccr≥60 ml/min 10. no history of chemotherapy 11. at the enrollment, the past operation has been over 4 weeks and the subject recovered. 12. for the female subject with the intact uterus, if amenorrhea is less than 24 months, pregnancy test must be negative within 28 days of enrollment. If pregnancy test has been past 7 days at the time of initial chemotherapy, urine pregnancy test must be done. 13. the authorized ICF must be signed
Exclusion criteria
1. having the other cancer in the recent five years, cured skin basal cell carcinoma and cervical carcinoma excluded. 2. having the evidence of CNS metastasis, no matter if treated; if being suspicious of CNS metastasis, CNS MRI or enhanced CT scan must be done within 28 days of enrollment. 3. AST and /or ALT\>2.5×normal ULN, and ALP\>5×normal ULN. 4. radiotherapy in the past (excluding palliative radiotherapy for pain relief and the measurable tumor outside the radio field) 5. chemotherapy in the past (excluding bisphosphonates ) 6. having the other uncontrolled diseases. 7. the female in pregnancy or feeding. 8. the subjects with the productivity capacity, but refusal to use the effective contraception measure. 9. participating in other clinical trial and at the time of treatment period. 10. allergy to the tested drugs 11. having the other uncontrolled diseases 12. BMT had been done.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progress free survival | 9 months | after being enrolled, the subjects will be subject to 4 cycles chemotherapy (each cycle: 21 days). if complete response/partial response/stable desease is confirmed, the subjects will be followed up till to the sixth months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | 3 months | the effectiveness will be evaluated after 2 cycles of chemotherapy is finished. 4 cycles of chemotherapy is needed for each subject. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 10 months | Adverse Events will be recorded and monitored till to normal or basal level achieved. |
Countries
China
Outcome results
None listed