Advanced Primary Lung Adenocarcinoma Clinical Trial
Official title:
The Use of CT Perfusion to Determine the Normalization Window Period in the Treatment of Advanced Primary Lung Adenocarcinoma With Endostar
To evaluate the change of blood perfusion before/after the use of Endostar, discuss the time sequence of Endostar TM in treating advanced lung adenocarcinoma in normalization window period.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | July 2013 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Histologically or cytologically newly diagnosed as unresectable and metastasis advanced lung adenocarcinoma(Stage IV, Seventh Edition of the UICC/AJCC Classification for Lung Cancer). - At least one measurable objective tumor lesion, spiral CT or PET-CT examination: the shortest diameter =2cm,and no obvious necrosis - Life expectancy =12weeks - Patients receive palliative radiotherapy for bone's pain relief; patients receive radiotherapy for brain metastasis?patients after brain transfer operation or radiation therapy are allowed to enter the research. - 18=Patients'age <70 years. - Electrocolonogram (ECOG) Score:0-1. - Granulocyte count = 2.0×109/L, platelet count = 100×109/L. - Serum bilirubin within the normal range. - Aspartate aminotransferase ( AST ), Alanine aminotransferase ( ALT ) within the normal range(if the patients is diagonosed as liver metastasis,his/her AST/ALT should not surpass 1.5 times of the normal range ). - Serum creatinine within the normal range and creatinine clearance rate =60ml/min - Compliance with research requirements and be able to follow up. - Within 72 hours before the treatment, all women pregnant with pregnant possibility should undergo pregnancy test and get negative results. - Patients with fertility ability should take effective contraceptive techniques. - Sign informed consent of this clinic trial. Exclusion Criteria: - Lung adenocarcinoma patients who received systemic chemotherapy/thoracic radiotherapy/targeted therapy - Received resection, cutting or aspiration within seven days - Any unstable systemic diseases (including peptic ulcer?active infection?grade4 hypertension?unstable angina?congestive heart failure?liver, metabolic disorders or fracture?unhealing wound ) - Chronic kidney disease history(including chronic nephritis, nephrotic syndrome, Obstruction of urinary tract etc. caused by Urinary calculus) - have to use anticoagulant drugs at the same time - patients with obvious coagulation disorders?active bleeding and bleeding tendency - Any other malignancies (complete cure of cervical carcinoma in situ/basal cell carcinoma/squamous cell carcinoma are excluded )happened within 5 years. - Signifinant weight loss, weight lost during the 6 weeks more than or equal to 10% - Patients who take bone metastasis as the only observing index - Allergic to escherichia coli preparation - Used Endostar before - Lactating women - Contraindications written on Pemetrexed?Carboplatin?Dexamethasone instructions - Allergic to radiographic contrast agents - In the middle or planning to attend other clinic trails |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| China | The Department of Thoracic Oncology in West China Hospital of Sichuan University | Chengdu | Sichuan |
| Lead Sponsor | Collaborator |
|---|---|
| Simcere Pharmaceutical Co., Ltd |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | the change of blood perfusion before/after the use of Endostar | per 3 weeks | No | |
| Secondary | tumor to progress | tumor to progress | 6 months | No |
| Secondary | clinical benefit rate | per 6 weeks | No | |
| Secondary | Adverse Drug Reaction | NCI-CTCAE V3.0 | per 1 day | Yes |