- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01564329
The Use of CT Perfusion to Determine the Normalization Window Period in the Treatment of Advanced Primary Lung Adenocarcinoma With Endostar
March 23, 2012 updated by: Simcere Pharmaceutical Co., Ltd
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- Recruiting
- The Department of Thoracic Oncology in West China Hospital of Sichuan University
-
Contact:
- Meijuan Huang, MD
-
Contact:
- You Lu, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the change of blood perfusion before/after the use of Endostar
Time Frame: per 3 weeks
|
per 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tumor to progress
Time Frame: 6 months
|
tumor to progress
|
6 months
|
clinical benefit rate
Time Frame: per 6 weeks
|
per 6 weeks
|
|
Adverse Drug Reaction
Time Frame: per 1 day
|
NCI-CTCAE V3.0
|
per 1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Anticipated)
April 1, 2013
Study Completion (Anticipated)
July 1, 2013
Study Registration Dates
First Submitted
March 21, 2012
First Submitted That Met QC Criteria
March 23, 2012
First Posted (Estimate)
March 27, 2012
Study Record Updates
Last Update Posted (Estimate)
March 27, 2012
Last Update Submitted That Met QC Criteria
March 23, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Adenocarcinoma
- Adenocarcinoma of Lung
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Endostar protein
Other Study ID Numbers
- sim-endo-201201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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