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Trial record 1 of 1 for:    00324805
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Chemotherapy With or Without Bevacizumab in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00324805
Recruitment Status : Active, not recruiting
First Posted : May 11, 2006
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Collaborators:
Cancer and Leukemia Group B
NCIC Clinical Trials Group
North Central Cancer Treatment Group
Southwest Oncology Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Stage IB Non-Small Cell Lung Carcinoma
Stage IIA Non-Small Cell Lung Carcinoma
Stage IIB Non-Small Cell Lung Carcinoma
Stage IIIA Non-small Cell Lung Cancer
Interventions: Biological: Bevacizumab
Drug: Cisplatin
Drug: Docetaxel
Drug: Gemcitabine Hydrochloride
Drug: Pemetrexed Disodium
Drug: Vinorelbine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited between June 1, 2007 and September 20, 2013 from ECOG-ACRIN, SWOG, RTOG, CALGB, NCCTG, NCIC-CTG, NSABP, ACOSOG, and CTSU sites.

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
Arm I (Chemotherapy)

Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 intravenously (IV) on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1

Cisplatin: Given IV

Docetaxel: Given IV

Gemcitabine Hydrochloride: Given IV

Pemetrexed Disodium: Given IV

Vinorelbine: Given IV

Arm II (Chemotherapy, Bevacizumab)

Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.

Bevacizumab: Given IV

Cisplatin: Given IV

Docetaxel: Given IV

Gemcitabine Hydrochloride: Given IV

Pemetrexed Disodium: Given IV

Vinorelbine: Given IV


Participant Flow:   Overall Study
    Arm I (Chemotherapy)   Arm II (Chemotherapy, Bevacizumab)
STARTED   749   752 
Started Assigned Therapy   737   735 
COMPLETED   599   269 
NOT COMPLETED   150   483 
Adverse Event                62                203 
Progression                7                35 
Withdrawal by Subject                51                174 
Death                6                9 
Alternative therapy                4                8 
Other complicating disease                1                9 
Other reasons                7                26 
Other                0                2 
Did not start therapy                12                17 



  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.
All randomized patients

Reporting Groups
  Description
Arm I (Chemotherapy)

Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1

Cisplatin: Given IV

Docetaxel: Given IV

Gemcitabine Hydrochloride: Given IV

Pemetrexed Disodium: Given IV

Vinorelbine: Given IV

Arm II (Chemotherapy, Bevacizumab)

Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.

Bevacizumab: Given IV

Cisplatin: Given IV

Docetaxel: Given IV

Gemcitabine Hydrochloride: Given IV

Pemetrexed Disodium: Given IV

Vinorelbine: Given IV

Total Total of all reporting groups

Baseline Measures
   Arm I (Chemotherapy)   Arm II (Chemotherapy, Bevacizumab)   Total 
Overall Participants Analyzed 
[Units: Participants]
 749   752   1501 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.7  (9.0)   60.8  (8.7)   60.8  (8.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      374  49.9%      381  50.7%      755  50.3% 
Male      375  50.1%      371  49.3%      746  49.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      19   2.5%      29   3.9%      48   3.2% 
Not Hispanic or Latino      680  90.8%      688  91.5%      1368  91.1% 
Unknown or Not Reported      50   6.7%      35   4.7%      85   5.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   0.1%      5   0.7%      6   0.4% 
Asian      22   2.9%      16   2.1%      38   2.5% 
Native Hawaiian or Other Pacific Islander      3   0.4%      2   0.3%      5   0.3% 
Black or African American      74   9.9%      57   7.6%      131   8.7% 
White      642  85.7%      660  87.8%      1302  86.7% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      7   0.9%      12   1.6%      19   1.3% 
Chemotherapy 
[Units: Participants]
Count of Participants
     
Cisplatin/Vinorelbine      187  25.0%      190  25.3%      377  25.1% 
Cisplatin/Docetaxel      172  23.0%      171  22.7%      343  22.9% 
Cisplatin/Gemcitabine      142  19.0%      141  18.8%      283  18.9% 
Cisplatin/Pemetrexed      248  33.1%      249  33.1%      497  33.1% 
Unknown/Missing      0   0.0%      1   0.1%      1   0.1% 
Histology 
[Units: Participants]
Count of Participants
     
Squamous      216  28.8%      206  27.4%      422  28.1% 
Adenocarcinoma      424  56.6%      450  59.8%      874  58.2% 
Large cell      22   2.9%      16   2.1%      38   2.5% 
Bronchioloalveolar carcinoma (BAC)      8   1.1%      5   0.7%      13   0.9% 
Not otherwise specified (NOS)      24   3.2%      16   2.1%      40   2.7% 
Combined/mixed      45   6.0%      48   6.4%      93   6.2% 
Other      10   1.3%      10   1.3%      20   1.3% 
Unknown/missing      0   0.0%      1   0.1%      1   0.1% 
Performance Status 
[Units: Participants]
Count of Participants
     
Fully active      439  58.6%      440  58.5%      879  58.6% 
Ambulatory      310  41.4%      310  41.2%      620  41.3% 
Unknown/missing      0   0.0%      2   0.3%      2   0.1% 
Urine protein:creatinine (UPC) ratio 
[Units: Ratio]
Mean (Standard Deviation)
 0.31  (3.10)   0.18  (0.92)   0.25  (2.28) 
Urine protein 
[Units: mg/dL]
Mean (Standard Deviation)
 95.26  (32.28)   100.25  (32.28)   97.79  (41.86) 


  Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: From registration to death, up to 10 years ]

2.  Secondary:   Disease-free Survival   [ Time Frame: From registration to death, up to 10 years ]

3.  Other Pre-specified:   Perform Analyses of Tissue and Blood to Establish Factors That Predict for Clinical Outcome in Patients Receiving Chemotherapy, With or Without Bevacizumab, for Resected Early Stage NSCLC.   [ Time Frame: From registration to death, up to 10 years ]

4.  Other Pre-specified:   To Determine Whether Smoking Status is Linked to Outcome for Patients With Resected Stage IB – IIIA NSCLC Treated With Chemotherapy With or Without Bevacizumab in the Adjuvant Setting.   [ Time Frame: From registration to death, up to 10 years ]

5.  Other Pre-specified:   Toxicity Rates as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0   [ Time Frame: Up to 1 year post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: ECOG-ACRIN Statistical Center
phone: 617-632-3012


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

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00324805     History of Changes
Other Study ID Numbers: NCI-2009-00509
NCI-2009-00509 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000475774 ( Registry Identifier: Clinical Data Repository )
E1505 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
E1505 ( Other Identifier: CTEP )
U10CA180820 ( U.S. NIH Grant/Contract )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: May 10, 2006
First Posted: May 11, 2006
Results First Submitted: January 12, 2018
Results First Posted: February 14, 2018
Last Update Posted: February 14, 2018