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

This study is currently recruiting participants.
Verified March 2012 by Simcere Pharmaceutical Co., Ltd
Sponsor:
Information provided by (Responsible Party):
Simcere Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01564329
First received: March 21, 2012
Last updated: March 23, 2012
Last verified: March 2012

March 21, 2012
March 23, 2012
March 2012
April 2013   (final data collection date for primary outcome measure)
the change of blood perfusion before/after the use of Endostar [ Time Frame: per 3 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01564329 on ClinicalTrials.gov Archive Site
  • tumor to progress [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    tumor to progress
  • clinical benefit rate [ Time Frame: per 6 weeks ] [ Designated as safety issue: No ]
  • Adverse Drug Reaction [ Time Frame: per 1 day ] [ Designated as safety issue: Yes ]
    NCI-CTCAE V3.0
Same as current
Not Provided
Not Provided
 
The Use of CT Perfusion to Determine the Normalization Window Period in the Treatment of Advanced Primary Lung Adenocarcinoma With Endostar
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Advanced Primary Lung Adenocarcinoma
Drug: endostar
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.
  • Experimental: endostar2
    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.
    Intervention: Drug: endostar
  • Experimental: endostar1
    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.
    Intervention: Drug: endostar
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
July 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: You Lu, MD 86-028-85422114 radyoulu@hotmail.com
Contact: Meijuan Huang, MD 86-028-85422114 hmj107@163.com
China
 
NCT01564329
sim-endo-201201
Yes
Simcere Pharmaceutical Co., Ltd
Simcere Pharmaceutical Co., Ltd
Not Provided
Not Provided
Simcere Pharmaceutical Co., Ltd
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP