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Trial record 14 of 87 for:    lung cancer AND risk factors

Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01813721
Recruitment Status : Completed
First Posted : March 19, 2013
Results First Posted : December 24, 2014
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Chemotherapy-induced Febrile Neutropenia

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

The first patient was enrolled on 13 December 2012 and the last patient enrolled on 08 January 2014.

There were 205 registered investigators, 35 of whom did not enrol any participants and 5 who did not enrol any eligible participants and were excluded from the primary analysis set - investigators (PASI).


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Enrolled Patients Participants with cancer who were planning to receive standard dose chemotherapy regimens with a documented intermediate risk (10% to 20%) of febrile neutropenia (FN).

Participant Flow:   Overall Study
    All Enrolled Patients
STARTED   1007 [1] 
COMPLETED   943 
NOT COMPLETED   64 
Ineligibility determined                63 
Withdrawal by Subject                1 
[1] Indicates number of participants enrolled



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Primary Analysis Set (PAS) is the set of all participants who satisfy the eligibility criteria and had at least one FN risk factor ranked by the investigator in their Subject Assessment.

Reporting Groups
  Description
Primary Analysis Set No text entered.

Baseline Measures
   Primary Analysis Set 
Overall Participants Analyzed 
[Units: Participants]
 944 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.8  (11.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      554  58.7% 
Male      390  41.3% 
Tumor Type 
[Units: Participants]
 
Breast cancer   395 
Non-small cell lung cancer (NSCLC)   248 
Non-Hodgkin’s lymphoma (NHL)   182 
Small-cell lung cancer (SCLC)   119 
Investigator Specialty [1] 
[Units: Investigators]
 
Medical Oncologist   110 
Hematologist   31 
Pulmonologist   10 
Radiation Oncologist   8 
Medical Gynecologist   4 
Gynecological Surgeon   2 
[1] Data provided for the Primary analysis Set-Investigators, consisting of the 165 investigators who contributed participants to the primary analysis set.
Number of years in oncology/hematology clinical practice 
[Units: Investigators]
 
> 10 years   117 
≤ 10 years   48 


  Outcome Measures

1.  Primary:   Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia   [ Time Frame: Baseline (prior to participant enrolment) ]

2.  Primary:   Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)   [ Time Frame: Assessed at Baseline, prior to participant enrolment. ]

3.  Primary:   Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor   [ Time Frame: At enrolment, prior to chemotherapy initiation ]

4.  Primary:   Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important   [ Time Frame: At enrolment, prior to chemotherapy initiation. ]

5.  Secondary:   Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important   [ Time Frame: Assessed at baseline, prior to participant enrolment. ]

6.  Secondary:   Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty   [ Time Frame: Assessed at baseline, prior to participant enrolment. ]

7.  Secondary:   Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology   [ Time Frame: Assessed at baseline, prior to participant enrolment. ]

8.  Secondary:   Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type   [ Time Frame: Assessed at baseline, prior to participant enrolment. ]

9.  Secondary:   Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important   [ Time Frame: At enrolment, prior to chemotherapy initiation. ]

10.  Secondary:   Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country   [ Time Frame: At enrolment, prior to chemotherapy initiation. ]

11.  Secondary:   Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty   [ Time Frame: At enrolment, prior to chemotherapy initiation. ]

12.  Secondary:   Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology   [ Time Frame: At enrolment, prior to chemotherapy initiation. ]

13.  Secondary:   Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type   [ Time Frame: At enrolment, prior to chemotherapy initiation. ]

14.  Secondary:   Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type   [ Time Frame: At enrolment, prior to chemotherapy initiation. ]

15.  Secondary:   Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty   [ Time Frame: Assessed at Baseline, prior to participant enrolment. ]

16.  Secondary:   Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology   [ Time Frame: Assessed at Baseline, prior to participant enrolment. ]

17.  Secondary:   Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type   [ Time Frame: Assessed at Baseline, prior to participant enrolment. ]

18.  Secondary:   Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country   [ Time Frame: At enrolment, prior to chemotherapy initiation. ]

19.  Secondary:   Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty   [ Time Frame: At enrolment, prior to chemotherapy initiation. ]

20.  Secondary:   Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology   [ Time Frame: At enrolment, prior to chemotherapy initiation. ]

21.  Secondary:   Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type   [ Time Frame: At enrolment, prior to chemotherapy initiation. ]

22.  Secondary:   Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type   [ Time Frame: At enrolment, prior to chemotherapy initiation. ]

23.  Secondary:   Percentage of Participants With an Investigator-assessed FN Risk at or Above the Investigator Self-reported FN-risk Intervention Threshold Who Were Planned to Receive G-CSF PP   [ Time Frame: At Baseline and at enrolment, prior to chemotherapy initiation. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01813721     History of Changes
Other Study ID Numbers: 20110146
First Submitted: January 8, 2013
First Posted: March 19, 2013
Results First Submitted: December 4, 2014
Results First Posted: December 24, 2014
Last Update Posted: March 15, 2017