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

Primary Purpose

Advanced Primary Lung Adenocarcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
endostar
Sponsored by
Simcere Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Advanced Primary Lung Adenocarcinoma focused on measuring endostar, CT Perfusion, Advanced Primary Lung Adenocarcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Department of Thoracic Oncology in West China Hospital of Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

endostar2

endostar1

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

the change of blood perfusion before/after the use of Endostar

Secondary Outcome Measures

tumor to progress
tumor to progress
clinical benefit rate
Adverse Drug Reaction
NCI-CTCAE V3.0

Full Information

First Posted
March 21, 2012
Last Updated
March 23, 2012
Sponsor
Simcere Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01564329
Brief Title
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Simcere Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Primary Lung Adenocarcinoma
Keywords
endostar, CT Perfusion, Advanced Primary Lung Adenocarcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
endostar2
Arm Type
Experimental
Arm Description
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.
Arm Title
endostar1
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
endostar
Intervention Description
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.
Primary Outcome Measure Information:
Title
the change of blood perfusion before/after the use of Endostar
Time Frame
per 3 weeks
Secondary Outcome Measure Information:
Title
tumor to progress
Description
tumor to progress
Time Frame
6 months
Title
clinical benefit rate
Time Frame
per 6 weeks
Title
Adverse Drug Reaction
Description
NCI-CTCAE V3.0
Time Frame
per 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
You Lu, MD
Phone
86-028-85422114
Email
radyoulu@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Meijuan Huang, MD
Phone
86-028-85422114
Email
hmj107@163.com
Facility Information:
Facility Name
The Department of Thoracic Oncology in West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meijuan Huang, MD
First Name & Middle Initial & Last Name & Degree
You Lu, MD

12. IPD Sharing Statement

Learn more about this trial

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

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