Radiotherapy Planning Using Fluciclovine PET in Patients With Newly Diagnosed Glioblastoma
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|ClinicalTrials.gov Identifier: NCT04840069|
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : January 13, 2023
|Condition or disease||Intervention/treatment||Phase|
|Newly Diagnosed Glioblastoma||Drug: Fluciclovine PET guided Radiotherapy||Phase 2|
The goal of this study is to see if the use of PET in planning radiotherapy can reduce these local failures.
Glioblastoma (GBM) is the most common primary malignant brain tumor. Newly diagnosed glioblastoma management includes maximum safe resection followed by radiotherapy with concurrent temozolomide, followed by maintenance temozolomide for 6 - 12 cycles. This postoperative chemoradiotherapy approach has resulted in a significant increase in median PFS (5.0 vs. 6.9 months) and OS (12.1 vs. 14.6 months) compared to radiotherapy alone (Stupp 2005). However, despite such multi-modality therapy, the median survival for GBM remains poor at approximately 15-16 months in contemporary series (Grossman, Ye et al. 2010, Gilbert, Wang et al. 2013 vs 2010).
Recently, a randomized trial of tumor-treating fields (TTF or Optune) plus temozolomide demonstrated the benefit of this treatment in newly diagnosed glioblastoma that led to FDA approval of the device (Stupp 2015, Stupp 2017). However despite these advances, most patients still have a poor prognosis with median survival of 16-21 months. Although adjuvant chemoradiotherapy has been shown to increase survival, a predominant pattern of failure remains local (Chan, Lee et al. 2002, Milano, Okunieff et al. 2010). Therefore, better therapeutic options are needed for this disease.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Randomized Clinical Trial of Radiotherapy Planning Using Conventional Imaging +/- Fluciclovine PET in Patients With Newly Diagnosed Glioblastoma|
|Actual Study Start Date :||June 7, 2021|
|Estimated Primary Completion Date :||March 30, 2024|
|Estimated Study Completion Date :||March 30, 2024|
No Intervention: MRI-guided radiotherapy
Patients will undergo standard of care MRI-guided radiotherapy.
Experimental: MRI + Fluciclovine PET-guided radiotherapy
Patients will undergo MRI + Fluciclovine PET-guided radiotherapy
Drug: Fluciclovine PET guided Radiotherapy
PET+MRI Based There is no GTV_5400. The GTV_6000 will be defined as the surgical cavity inclusive of any remaining tumor enhancement and the hypermetabolic volume. CTV_5400 will include the GTV_6000 plus a margin of 1.0 cm which may be reduced around natural barriers to tumor growth such as the skull, ventricles, falx, etc. CTV_5400 must also include the entirety of the GTV_6000. There is no CTV_6000. PTV_5400 is the CTV_5400 plus a geometric 3 mm expansion in all dimensions; PTV_6000 is GTV_6000 plus a geometric 3 mm expansion in all dimensions. PTV may extend beyond bony margins and the skin surface. The PTV_5400 must contain the PTV_6000. In the setting of multi-focal disease, the primary target volumes will be defined as above, but for satellite lesions, the GTV_6000 will be defined as any tumor enhancement and hypermetabolic volume. There will be no CTV_6000. PTV_6000 will be defined as GTV_6000 plus a geometric 3 mm expansion in all dimensions.
- Patterns of Failure [ Time Frame: 36 months ]To assess whether incorporating fluciclovine PET into radiotherapy planning significantly changes the in-field and out-of-field radiographic progression rates, by comparison to traditional MRI-based radiotherapy
- Defining Tumor Volume [ Time Frame: 36 months ]2. To determine the effect fluciclovine PET has on definition of the tumor volume, as compared to traditional MRI-based radiotherapy.
- Survival using MRI radiotherapy [ Time Frame: 36 months ]To quantify overall and progression free survival utilizing MRI cohort.
- Overall survival utilizing MRI+PET radiotherapy [ Time Frame: 36 months ]To quantify overall survival utilizing MRI+PET-based radiotherapy
- Progression free survival utilizing MRI+PET-based radiotherapy [ Time Frame: 36 months ]To quantify progression free survival utilizing MRI+PET-based
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): NCT04840069
|Contact: Phase 0 Navigatoremail@example.com|
|United States, Arizona|
|St. Joseph's Hospital and Medical Center||Recruiting|
|Phoenix, Arizona, United States, 85013|
|Contact: Phase 0 Navigator 602-406-8605 firstname.lastname@example.org|
|Principal Investigator: Igor Barani, MD|