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Trial record 73 of 580 for:    Advanced | cancer | bevacizumab

A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer (INOVA)

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ClinicalTrials.gov Identifier: NCT00865189
Recruitment Status : Completed
First Posted : March 19, 2009
Results First Posted : August 4, 2017
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Rectal Cancer
Interventions: Drug: Bevacizumab
Drug: Oxaliplatin
Drug: Folinic Acid
Drug: 5-fluorouracil
Radiation: Preoperative Radiotherapy
Procedure: Surgery

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 92 participants with resectable rectal cancer were selected and 91 participants were randomized into the study. One participant was not randomized due to non-compliance with the inclusion/exclusion criteria.

Reporting Groups
  Description
Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (intravenous [IV] infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the total mesorectal excision (TME) technique.
Arm B (Bevacizumab, Chemoradiotherapy) In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.

Participant Flow:   Overall Study
    Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)   Arm B (Bevacizumab, Chemoradiotherapy)
STARTED   46   45 
COMPLETED   34   26 
NOT COMPLETED   12   19 
Other                1                2 
Death                4                11 
Lost to Follow-up                6                6 
Withdrawal by Subject                1                0 



  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.
Intent to treat (ITT) population included all the randomized participants who received at least one dose of treatment.

Reporting Groups
  Description
Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) In this arm, participants underwent 3 phases of treatment. During the Phase 1, participants received induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 was surgery involving a radical rectal excision using the TME technique.
Arm B (Bevacizumab, Chemoradiotherapy) In this arm, participants received the Phase 2 and Phase 3 treatments only. The phase 2 consisted of 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 was surgery involving a radical rectal excision using the TME technique.
Total Total of all reporting groups

Baseline Measures
   Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)   Arm B (Bevacizumab, Chemoradiotherapy)   Total 
Overall Participants Analyzed 
[Units: Participants]
 46   45   91 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      33  71.7%      29  64.4%      62  68.1% 
>=65 years      13  28.3%      16  35.6%      29  31.9% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      15  32.6%      15  33.3%      30  33.0% 
Male      31  67.4%      30  66.7%      61  67.0% 


  Outcome Measures

1.  Primary:   Percentage of Participants With Tumor Sterilization Defined by ypT0-N0   [ Time Frame: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment) ]

2.  Secondary:   Percentage of Participants With Tumor Down-Staging (ypT0-pT2)   [ Time Frame: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment) ]

3.  Secondary:   Percentage of Participants With Local and Distant Recurrences   [ Time Frame: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment) ]

4.  Secondary:   Percentage of Participants With Second Cancer, Local or Regional Recurrence, Distant Metastasis, or Death   [ Time Frame: Baseline up to approximately 6 years ]

5.  Secondary:   Disease-Free Survival (DFS)   [ Time Frame: From first time of the treatment administration to the date of second cancer, local or regional recurrence, distant metastasis or death from any cause (up to approximately 6 years) ]

6.  Secondary:   Percentage of Participants Who Died   [ Time Frame: Baseline up to approximately 6 years ]

7.  Secondary:   Overall Survival   [ Time Frame: From the first treatment administration to the date of death (up to approximately 6 years) ]

8.  Secondary:   Number of Cycles of Induction Chemotherapy   [ Time Frame: 6 cycles (12 weeks; cycle length = 14 days) ]

9.  Secondary:   Number of Cycles of Chemotherapy   [ Time Frame: Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7 ]

10.  Secondary:   Number of Cycles of Radiotherapy   [ Time Frame: Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7 ]

11.  Secondary:   Percentage of Participants With Surgery   [ Time Frame: Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment ]


  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: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00865189     History of Changes
Other Study ID Numbers: ML19202
2006-003472-35 ( EudraCT Number )
First Submitted: March 18, 2009
First Posted: March 19, 2009
Results First Submitted: April 13, 2017
Results First Posted: August 4, 2017
Last Update Posted: August 4, 2017