Clinical trial NCT01564329: The Use of CT Perfusion to Determine the Normalization Window Period in the Treatment of Advanced Primary Lung Adenocarcinoma With Endostar
Official title: The Use of CT Perfusion to Determine the Normalization Window Period in the Treatment of Advanced Primary Lung Adenocarcinoma With Endostar
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Primary Lung Adenocarcinoma
Keywords: endostar
CT Perfusion
Advanced Primary Lung Adenocarcinoma
Lead sponsor: Simcere Pharmaceutical Co., Ltd
Sponsor class: OTHER
First posted: 2012-03-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: the change of blood perfusion before/after the use of Endostar
timeFrame: per 3 weeks
Secondary outcomes:
measure: tumor to progress
timeFrame: 6 months
measure: clinical benefit rate
timeFrame: per 6 weeks
measure: Adverse Drug Reaction
timeFrame: per 1 day
Other outcomes:
Locations:
city: Chengdu
country: China
facility: The Department of Thoracic Oncology in West China Hospital of Sichuan University
state: Sichuan
Study officials:
References: