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Gliadel Wafer and Fluorescence-Guided Surgery With 5-ALA Followed by Radiation Therapy And Temozolomide in Treating Patients With Primary Glioblastoma

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ClinicalTrials.gov Identifier: NCT01310868
Recruitment Status : Completed
First Posted : March 9, 2011
Results First Posted : August 14, 2017
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
University College, London

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Glioblastoma
Interventions: Drug: 5-ALA
Drug: Gliadel wafers
Radiation: Radiotherapy as normal based on standard clinical protocols determined by the neuro-oncologist
Drug: Concomitant chemotherapy as normal based on standard clinical protocols determined by the neuro-oncologist
Drug: Adjuvant chemotherapy as normal based on standard clinical protocols determined by the neuro-oncologist

  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
Study entry was based on imaging that has been judged to have typical appearances of a primary glioblastoma multiforme (GBM). Patients would have neurosurgery and GBM would be confirmed peri/post-operatively. If not GBM patients OR wafers+ 5-ala not administered then remain in the trial for follow up but were not included in the final analysis.

Reporting Groups
  Description
5-ALA and Gliadel Wafers

This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM.

5-ALA: 5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers

Gliadel wafers: The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection.


Participant Flow:   Overall Study
    5-ALA and Gliadel Wafers
STARTED   72 
COMPLETED   59 
NOT COMPLETED   13 
Do not have histologically confirmed GBM                13 



  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.
No text entered.

Reporting Groups
  Description
5-ALA and Gliadel Wafers

This is a single arm feasibility study to evaluate the safety and tolerability of combining 2 technologies (5-ALA and Gliadel wafers) in the surgical management of patients with GBM.

5-ALA: 5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers

Gliadel wafers: The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection.


Baseline Measures
   5-ALA and Gliadel Wafers 
Overall Participants Analyzed 
[Units: Participants]
 72 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      54  75.0% 
>=65 years      18  25.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      23  31.9% 
Male      49  68.1% 
Region of Enrollment 
[Units: Participants]
 
United Kingdom   72 


  Outcome Measures

1.  Primary:   Safety, Tolerability, and Feasibility of Combination Intra-operative 5-ALA and Gliadel Wafers Prior to Adjuvant Radiotherapy Plus Temozolomide   [ Time Frame: Date of surgery to end of temozolomide and radiotherapy treatment (up to 34 weeks) ]

2.  Secondary:   Time to Clinical Progression   [ Time Frame: from the date of surgery to the date of the first MRI scan fitting the criteria for progression, or the date the clinical detrioration or death was first reported ]

3.  Secondary:   Survival at 24 Months   [ Time Frame: from the date of surgery to 24 months ]


  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: GALA-5 Trial Coorinator
Organization: University College London
phone: 0207 679 9898
e-mail: ctc.sponsor@ucl.ac.uk



Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01310868     History of Changes
Other Study ID Numbers: CDR0000696316
CRUK-UCL-09-0398 ( Other Grant/Funding Number: Cancer Research UK and Samantha Dixon Brain Tumour Trust )
2010-022496-66 ( EudraCT Number )
09/0398 ( Other Identifier: University College London )
10/H0304/100 ( Other Identifier: NRES Committee East of England - Cambridge East )
First Submitted: March 5, 2011
First Posted: March 9, 2011
Results First Submitted: May 2, 2017
Results First Posted: August 14, 2017
Last Update Posted: October 5, 2017