Recurrent or Progressive Glioblastoma
Conditions
Keywords
glioblastoma
Brief summary
This clinical trial is a prospective study of radiosurgery treatment for progressive GBM to test 1)the efficacy of radiosurgery for recurrent/progressive GBM compared to chemotherapy , and 2) the role of diffusion-weighted image (DWI) to predict the early tumor progression and treatment response.
Interventions
DRUGBevacizumab
DRUGChemotherapy
RADIATIONFractionated radiosurgery
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Histologically proven intracranial glioblastoma multiforme with pathologic or imaging confirmation of tumor progression or regrowth after failure of two previous treatment regimens * Initial low-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma * History and physical exam, including neurologic examination, within 4 weeks prior to registration
Exclusion criteria
• Warfarin or LMW heparin patients must have no active bleeding or pathological condition that carries a high risk of bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local Tumor Control | 2 months |
| Overall Survival | 12 months |
| Progression Free Survival | 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fractionated Radiosurgery and Bevacizumab FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression
Bevacizumab
Chemotherapy
Fractionated radiosurgery | 18 |
| Bev With Chemo Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression
Bevacizumab
Chemotherapy | 17 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Fractionated Radiosurgery and Bevacizumab | Bev With Chemo | Total |
|---|---|---|---|
| Age, Continuous | 51.5 years STANDARD_DEVIATION 16.3 | 59.2 years STANDARD_DEVIATION 8.3 | 55.2 years STANDARD_DEVIATION 13.5 |
| Diagnosis Anaplastic astrocytoma | 2 Participants | 2 Participants | 4 Participants |
| Diagnosis Anaplastic oligodendroglioma | 0 Participants | 2 Participants | 2 Participants |
| Diagnosis Glioblastoma | 16 Participants | 13 Participants | 29 Participants |
| Neoadjuvant Chemotherapy | 16 Participants | 17 Participants | 33 Participants |
| Neoadjuvant RT Dose 54 | 0 Participants | 1 Participants | 1 Participants |
| Neoadjuvant RT Dose 59.4 | 1 Participants | 1 Participants | 2 Participants |
| Neoadjuvant RT Dose 60 | 17 Participants | 15 Participants | 32 Participants |
| On-Trial Chemotherapy BEV+Carboplatin | 15 Participants | 11 Participants | 26 Participants |
| On-Trial Chemotherapy BEV+etoposide | 1 Participants | 0 Participants | 1 Participants |
| On-Trial Chemotherapy BEV+irinotecan | 0 Participants | 0 Participants | 0 Participants |
| On-Trial Chemotherapy BEV+temozolomide | 1 Participants | 2 Participants | 3 Participants |
| On-Trial Chemotherapy No trial chemotherapy | 1 Participants | 4 Participants | 5 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 10 Participants |
| Sex: Female, Male Male | 14 Participants | 11 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 15 / 18 | 14 / 17 |
| other Total, other adverse events | 0 / 18 | 0 / 17 |
| serious Total, serious adverse events | 5 / 18 | 4 / 17 |
Outcome results
Primary
Local Tumor Control
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fractionated Radiosurgery and Bevacizumab | Local Tumor Control | 14 Participants |
| Bev With Chemo | Local Tumor Control | 4 Participants |
Primary
Overall Survival
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fractionated Radiosurgery and Bevacizumab | Overall Survival | 7.2 months |
| Bev With Chemo | Overall Survival | 4.8 months |
p-value: 0.11Log Rank
Primary
Progression Free Survival
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fractionated Radiosurgery and Bevacizumab | Progression Free Survival | 5.1 months |
| Bev With Chemo | Progression Free Survival | 1.8 months |
p-value: 0.001Log Rank