CompletedNCT05718466Updated Jul 17, 2023Results posted

Stereotactic Radiology Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-Line Chemotherapy

A Phase 3 interventional study of Bevacizumab and Chemotherapy in Recurrent or Progressive Glioblastoma, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-07-17.

Sponsored by Henry Ford Health System · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 35
Allocation: Randomized
Ages: 18 Years to 100 Years
Sex: All

Study 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.

Conditions studied

Recurrent or Progressive Glioblastoma

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Keywords

glioblastoma

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's enrollment of 35 is close to the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

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Lead sponsor

Henry Ford Health System is the lead sponsor of 293 studies on the registry; 50 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 100 Years
Sexes eligible: All
Accepts 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

Exclusion Criteria:

Warfarin or LMW heparin patients must have no active bleeding or pathological condition that carries a high risk of bleeding

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 35 participants (actual)

Study arms

Experimental
Fractionated Radiosurgery and Bevacizumab
FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression
Drug: Bevacizumab · Drug: Chemotherapy · Radiation: Fractionated radiosurgery
Active comparator
Bev with Chemo
Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression
Drug: Bevacizumab · Drug: Chemotherapy

Interventions

DrugBevacizumab
DrugChemotherapy
Also known as: Either irinotecan or temozolomide or carboplatin or etoposide
RadiationFractionated radiosurgery

What researchers measure

Primary outcomes

Local Tumor Control
Time frame: 2 months
Overall Survival
Time frame: 12 months
Progression Free Survival
Time frame: 12 months

Results

Posted Jul 17, 2023

Participant flow

Participant flow — Overall Study
Milestone	Fractionated Radiosurgery and Bevacizumab	Bev With Chemo
Started	18	17
Completed	17	14
Not completed	1	3
Withdrew: Withdrawal by subject	1	2
Withdrew: Death	0	1

Outcome measures

PrimaryLocal Tumor Control

Time frame:: 2 months
Reported as:: Count of participants · Participants

Local Tumor Control
Participants	Fractionated Radiosurgery and Bevacizumab	Bev With Chemo
Local Tumor Control	14	4

PrimaryOverall Survival

Time frame:: 12 months
Reported as:: Median · months

Overall Survival
months	Fractionated Radiosurgery and Bevacizumab	Bev With Chemo
Overall Survival	7.2 (6.1 to 8.1)	4.8 (1.7 to 7.6)

Statistical analysis

Fractionated Radiosurgery and Bevacizumab vs Bev With Chemo · Log Rank · p = 0.11

PrimaryProgression Free Survival

Time frame:: 12 months
Reported as:: Median · months

Progression Free Survival
months	Fractionated Radiosurgery and Bevacizumab	Bev With Chemo
Progression Free Survival	5.1 (4.1 to 6.2)	1.8 (1.2 to 2.8)

Statistical analysis

Fractionated Radiosurgery and Bevacizumab vs Bev With Chemo · Log Rank · p = 0.001

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Fractionated Radiosurgery and Bevacizumab	15/18 (83.3%)	5/18 (27.8%)	0/18 (0%)
Bev With Chemo	14/17 (82.4%)	4/17 (23.5%)	0/17 (0%)

Most frequent serious events

Most frequent serious events
Event	Fractionated Radiosurgery and Bevacizumab	Bev With Chemo
Cerebral EdemaNervous system disorders	0/18	1/17
ThrombocytopeniaBlood and lymphatic system disorders	0/18	1/17
Altered Mental StatusNervous system disorders	0/18	1/17
Intratumoral HemorrhageNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/18	1/17
Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders	1/18	0/17
HeadacheNervous system disorders	1/18	0/17
Nausea/VomitingGeneral disorders	1/18	0/17
New Onset WeaknessGeneral disorders	1/18	0/17
SeizureNervous system disorders	1/18	0/17

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Fractionated Radiosurgery and Bevacizumab	Bev With Chemo	Total
Mean	51.5 ± 16.3	59.2 ± 8.3	55.2 ± 13.5

Sex: Female, Male
Sex: Female, Male(Participants)	Fractionated Radiosurgery and Bevacizumab	Bev With Chemo	Total
Female	4	6	10
Male	14	11	25

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Fractionated Radiosurgery and Bevacizumab	Bev With Chemo	Total
Count of participants	—	—	0

Diagnosis
Diagnosis(Participants)	Fractionated Radiosurgery and Bevacizumab	Bev With Chemo	Total
Anaplastic astrocytoma	2	2	4
Anaplastic oligodendroglioma	0	2	2
Glioblastoma	16	13	29

Neoadjuvant RT Dose
Neoadjuvant RT Dose(Participants)	Fractionated Radiosurgery and Bevacizumab	Bev With Chemo	Total
54	0	1	1
59.4	1	1	2
60	17	15	32

Neoadjuvant Chemotherapy
Neoadjuvant Chemotherapy(Participants)	Fractionated Radiosurgery and Bevacizumab	Bev With Chemo	Total
Count of participants	16	17	33

On-Trial Chemotherapy
On-Trial Chemotherapy(Participants)	Fractionated Radiosurgery and Bevacizumab	Bev With Chemo	Total
BEV+Carboplatin	15	11	26
BEV+etoposide	1	0	1
BEV+irinotecan	0	0	0
BEV+temozolomide	1	2	3
No trial chemotherapy	1	4	5

Study locations

1 site

Henry Ford Health System
Detroit, Michigan 48202, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05718466
Lead sponsor: Henry Ford Health System
Responsible party: Salim Siddiqui, MD, PhD (Radiation Oncologist, Henry Ford Health System) — Principal investigator
First posted: Feb 8, 2023
Start date: Nov 2010
Primary completion: Dec 2016
Completion: Dec 2016
Results posted: Jul 17, 2023
Last update: Jul 17, 2023

Study contacts

Farzan Siddiqui, MD

study director · Henry Ford Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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