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Dose and Volume Escalation of Preoperative Brain Irradiation in GBM Patients -the POBIG Trial - (POBIG)

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ClinicalTrials.gov Identifier: NCT03582514
Recruitment Status : Withdrawn (The participating site went broke and no new participating sites have been found)
First Posted : July 11, 2018
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Brief Summary:
The pre-operative brain irradiation in GBM (POBIG) is a phase I-II study assessing the feasibility, safety and efficacy to irradiate (partially) the tumor in patients with a high suspicion of glioblastoma (GBM). After the single fraction of radiotherapy, patients will receive the standard treatment. The standard treatment consists of resection of the tumor followed by (chemo)radiation (i.e. radiotherapy +/- daily temozolomide (75mg/m2) for 6 weeks (60Gy/30fr) or for 3 weeks (40Gy/15fr)) and (if indicated) adjuvant temozolomide (150-200mg/m2, 5/28 days, 6 cycles).

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Radiation: Preoperative brain irradiation (single fraction) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Cohort inclusion is based on a 3+3 design. Three patients each are assigned to the Level 1 combinations of dose and volume. Each patient triplet is considered a cohort.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose and Volume Escalation of Preoperative Brain Irradiation in GBM Patients -the POBIG Trial -
Estimated Study Start Date : December 1, 2019
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose or volume radiation escalation

Patients with a biopsy proven GBM referred to our hospital or patients who are diagnosed with GBM based on the MRI (judged by the neuro-oncology multidisciplinary team) are to be considered for this study.

This GBM study assesses the feasibility, safety and efficacy of a preoperative single fraction. The phase-I part has a 3+3 dose or volume escalation design. The choice of dose or volume escalation is based on tumor volume and location. After the single fraction of radiotherapy, patients will receive the standard treatment.

Radiation: Preoperative brain irradiation (single fraction)
Dose and volume escalation of preoperative single fraction stereotactic radiotherapy.




Primary Outcome Measures :
  1. The feasibility of preoperative single fraction radiotherapy in GBM patients [ Time Frame: 4 years ]
    To assess the tumor control and (re)growth between surgery and post-operative radiotherapy.

  2. The single fraction dose and volume that can be safely given preoperatively [ Time Frame: 4 years ]
    To explore the single fraction dose and volume that can be safely given in a preoperative setting additional to the standard treatment of postoperative surgery and (chemo)radiation.

  3. The tumor volume differences measured between the post-surgery MRI and pre-radiotherapy MRI [ Time Frame: 4 years ]
    To confirm usability of the MRI to select GBM patients for preoperative single fraction radiotherapy.


Secondary Outcome Measures :
  1. Registration of postoperative surgical complications. [ Time Frame: 4 years ]
  2. Progression free survival. [ Time Frame: 4 years + 5 years follow-up ]
  3. Overall survival. [ Time Frame: 4 years + 5 years follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Newly diagnosed GBM (based on MRI imaging or biopsy)
  • Ability to undergo standard treatment consisting of (chemo)radiation and surgery (i.e. KPS > 70, indication that more than 70% of the tumor can be removed during surgery)
  • Neuro-oncology multidisciplinary team* consensus to include the patient for the current study
  • Signed written informed consent

Exclusion Criteria:

  • Prior or second invasive malignancy, except non-melanoma skin cancer, completely resected cervical or prostate cancer (with PSA of less than or equal to 0.1 ng/ml)
  • Suspicion of primary tumor on CT thorax/abdomen in case no biopsy is available
  • Inability to secure a "cold-spot" in the tumor (volume of 2 cc of the contrast enhancing tumor that should not receive irradiation dose, see Chapter 2 and 4)
  • Inability to secure radiotherapy dose constraints for organs at risk for either the neoadjuvant stereotactic radiosurgery or adjuvant fractionated radiotherapy (see Chapter 2 and 4)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582514


Locations
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Netherlands
The Netherlands Cancer Institute
Amsterdam, Noord-Holland, Netherlands, 1066CX
Medisch Centrum Slotervaart
Amsterdam, Noord-Holland, Netherlands, 1066EC
Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
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Principal Investigator: Gerben R Borst The Netherlands Cancer Institute
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT03582514    
Other Study ID Numbers: N18POB
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Netherlands Cancer Institute:
Radiotherapy
Preoperative single fraction
3+3 design
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue