The Use of CT Perfusion to Determine the Normalization Window Period in the Treatment of Advanced Primary Lung Adenocarcinoma With Endostar

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
The Use of CT Perfusion to Determine the Normalization Window Period in the Treatment of Advanced Primary Lung Adenocarcinoma With Endostar

Conditions
-----------------
Advanced Primary Lung Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: endostar


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endostar2<br>CT Perfusion Imaging(CTPI) at D0, D21 of the first cycle、D6, D14 of the second cycle, measure blood flow ( BF ), blood volume ( BV ), mean transit time ( MTT ), start time ( TTS ), time to peak ( TTP ), Patlak blood volume ( pBV ), vascular permeability etc. before/after tumor tissue treatment. | Drug: endostar<br>* Endostar TM 7.5mg/m2,intravenous drip, Day 1to Day 10;Pemetrexed 500mg/m2, intravenous drip, Day 6; Carboplatin AUC=5,intravenous drip, Day 6; 21 days as a cycle, 4 cycles in all.<br>|
| Experimental: endostar1<br>CT Perfusion Imaging(CTPI) at D0，D6, D14, D21 of the first period, measure blood flow ( BF ), blood volume ( BV ), mean transit time ( MTT ), start time ( TTS ), time to peak ( TTP ), Patlak blood volume ( pBV ), vascular permeability etc. before/after tumor tissue treatment. | Drug: endostar<br>* Endostar TM 7.5mg/m2,intravenous drip, Day 1to Day 10;Pemetrexed 500mg/m2, intravenous drip, Day 6; Carboplatin AUC=5,intravenous drip, Day 6; 21 days as a cycle, 4 cycles in all.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of blood perfusion before/after the use of Endostar |  | per 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor to progress | tumor to progress | 6 months | 
| clinical benefit rate |  | per 6 weeks | 
| Adverse Drug Reaction | NCI-CTCAE V3.0 | per 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endostar, CT Perfusion, Advanced Primary Lung Adenocarcinoma