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

Phase 2

• Conditions: Advanced Primary Lung Adenocarcinoma
• Interventions: Drug: endostar

• Registration Number: NCT01564329
• Lead Sponsor: Simcere Pharmaceutical Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-03
• Study Start: 2012-03
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-23
• Last Update Submitted: 2012-03-23
• Study First Posted: 2012-03-27
• Last Update Posted: 2012-03-27
• Primary Completion: 2013-04
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endostar1	endostar	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.
endostar2	endostar	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.

Primary Outcome Measures

Name	Time	Method
the change of blood perfusion before/after the use of Endostar	per 3 weeks

Secondary Outcome Measures

Name	Time	Method
tumor to progress	6 months	tumor to progress
clinical benefit rate	per 6 weeks
Adverse Drug Reaction	per 1 day	NCI-CTCAE V3.0

Trial Locations

Locations (1)

The Department of Thoracic Oncology in West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China