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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Simcere Pharmaceutical Co., Ltd

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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