Low Grade GliomaPhase 2NCT06132685
Post-Operative Dosing of Dexamethasone in Patients With Brain Tumors After a Craniotomy, PODS Trial
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Dexamethasone in people with Low Grade Glioma and Malignant Brain Glioma, run by Emory University at 1 site in United States.
Trial summary
This phase II trial tests the effect of decreasing (tapering) doses of dexamethasone on steroid side effects in patients after surgery to remove (craniotomy) a brain tumor. Steroids are the gold standard post-surgery treatment to reduce swelling (edema) at the surgical site to reduce neurological symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Grade Glioma, Malignant Brain Glioma, Malignant Brain Neoplasm
- What is being tested?
- Biospecimen Collection, Computed Tomography and Dexamethasone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2025to 30 Jul 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with radiographic findings consistent with either HGG, LGG, Meningioma, or brain metastasis
- Age equal to or above 18
Who cannot join
- Known hypothalamic-pituitary-adrenal (HPA) axis dysfunction
- Tumor causing compression of the sella or pituitary dysfunction
- Known immunodeficiency - including but not limited to severe combined immunodeficiency (SCID), common variable immunodeficiency (CVID), lymphocytopenia
- Taking immunosuppressive drugs - including but not limited to methotrexate, mycophenolate, rapamycin, tacrolimus, adalimumab, infliximab. Greater than two weeks of recent daily corticosteroid use or the use of corticosteroids equivalent to > 85 mg of dexamethasone in the last month
- Current lymphoma or leukemia
- History of solid organ transplant
Show all 9Show fewer
- Minors < 18
- Pregnant women
- History of cerebrovascular accident leading to neurologic deficit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Agnes Harutyunyan, aharuty@emory.edu
Kimberly Hoang, MD
About this study
Official title: Post-Operative Dosing of Steroids Post Craniotomy for Brain Tumor (PODS)
This phase II trial tests the effect of decreasing (tapering) doses of dexamethasone on steroid side effects in patients after surgery to remove (craniotomy) a brain tumor. Steroids are the gold standard post-surgery treatment to reduce swelling (edema) at the surgical site to reduce neurological symptoms. Although, corticosteroids reduce edema, they have side effects including high blood sugar, high blood pressure, and can impair wound healing. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response. It also works to treat other conditions by reducing swelling and redness. Tapering doses dexamethasone may decrease steroid side effects without increasing the risk of edema in patients with brain tumors after a craniotomy.
Read the detailed description
PRIMARY OBJECTIVES:
- The primary objective of this study is to evaluate the efficacy of a reduced dosage steroid schedule (RDS) in patients who have undergone craniotomy for high grade glioma (HGG), low grade glioma (LGG), brain metastasis (BM), and meningiomas as compared with the normal dosing schedule (NDS).
II. RDS after undergoing craniotomy for brain tumor has no impact on length of stay, 30 day readmission, and need for repeat imaging when compared to NDS.
SECONDARY OBJECTIVE:
- RDS after craniotomy for brain tumor has no impact on development of steroid related side effects (new onset or worsening hypertension, hyperglycemia, wound infection, impaired wound healing, steroid dependence, neuropsychiatric disturbance) when compared to NDS.
TERTIARY/EXPLORATORY OBJECTIVE:
- RDS after craniotomy has no effect on lymphocyte count and differential at 10-14 days after surgery.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (NDS): Patients receive tapering doses of dexamethasone on days 1-15. Patients also undergo blood sample collection at time of surgery, at follow up visits and optionally at wound check visit 10-14 days post operative at investigator availability. Patients additionally undergo magnetic resonance imaging (MRI) and computed tomography (CT) scan during inpatient stay as part of standard of care.
ARM II (RDS): Patients receive tapering doses of dexamethasone on days 1-4. Patients may receive dexamethasone intravenously (IV) and restart the taper if clinically indicated. Patients also undergo blood sample collection at time of surgery, follow up visits and optionally at wound check visit 10-14 days post operative at investigator availability. Patients additionally undergo MRI and CT scan during inpatient stay as part of standard of care.
- Being tested
- Biospecimen Collection, Computed Tomography, Dexamethasone, Magnetic Resonance Imaging, Questionnaire Administration
- Medical subject headings
- Brain Neoplasms, Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT scan
DexamethasoneDrug
Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex
Given dexamethasone or IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Undergo MRI
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (NDS) | Experimental | Patients receive tapering doses of dexamethasone on days 1-15. Patients also undergo blood sample collection at time of surgery, at follow up visits and optionally at wound check visit 10-14 days post operative at investigator availability. Patients additionally undergo MRI and CT scan during inpatient stay as part of standard of care. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Dexamethasone; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration |
| Arm II (RDS) | Experimental | Patients receive tapering doses of dexamethasone on days 1-4. Patients may receive dexamethasone IV and restart the taper if clinically indicated. Patients also undergo blood sample collection at time of surgery, follow up visits and optionally at wound check visit 10-14 days post operative at investigator availability. Patients additionally undergo MRI and CT scan during inpatient stay as part of standard of care. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Dexamethasone; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
The two-sample t-test or Mann-Whitney U test utilized to estimate the differences between the two groups. General linear model employed in the multivariable analysis to estimate the adjusted difference in length of hospital stay between the two groups after adjusting for other factors.
Measured: Up to 3 months
30-day repeat admission rate
Comparison between the two groups assessed using Fisher exact test or Chi-Square test. Logistic regression used to compare between the two groups after adjusting for other factors. Odds ratios (OR) and 95% confidence intervals (CIs) calculated to evaluate the strength of any association.
Measured: At 30 days after surgery
Need for repeat head imaging
Comparison between the two groups assessed using Fisher exact test or Chi-Square test. Logistic regression used to compare between the two groups after adjusting for other factors. OR and 95% CIs calculated to evaluate the strength of any association.
Measured: Up to 3 months
Secondary outcomes (9)
Incidence of new neurologic deficit
Comparison between the two groups assessed using Fisher exact test or Chi-Square test. Logistic regression used to compare between the two groups after adjusting for other factors. OR and 95% CIs calculated to evaluate the strength of any association.
Measured: At less than 30 days and at 3 months
Breakthrough seizures
Comparison between the two groups assessed using Fisher exact test or Chi-Square test. Logistic regression used to compare between the two groups after adjusting for other factors. OR and 95% CIs calculated to evaluate the strength of any association.
Measured: Up to 30 days after surgery
Evidence of Worsening Cerebral Edema
This measure will be a three-level scale determined by the final neuroradiology read of comparison imaging as either improved cerebral edema, stable cerebral edema, or worsened cerebral edema when evaluated on repeat CT Head without contrast.
Measured: Between 5 and 30 days after surgery
Evaluation for Steroid Dependence
This measure will be evaluated in a binary manner as either the patient having been successfully weaned off of all steroids or the patient remaining on supplemental daily steroids due to the inability to wean off of steroids due to symptomatic adrenal insufficiency. The assessment of adrenal insufficiency will not be done as part of this the study, this study will document the continued use of supplemental daily steroids at 3 month follow-up versus not.
Measured: At long term follow up to 3 months after surgery
Rate of new onset hypertension
Defined as sustained systolic blood pressure > 140. Comparison between the two groups assessed using Fisher exact test or Chi-Square test. Logistic regression used to compare between the two groups after adjusting for other factors. OR and 95% CIs calculated to evaluate the strength of any association.
Measured: During inpatient stay up to 3 months after surgery
Rate of new onset hyperglycemia
Defined as random blood glucose > 100 and/or new insulin requirement. Comparison between the two groups assessed using Fisher exact test or Chi-Square test. Logistic regression used to compare between the two groups after adjusting for other factors. OR and 95% CIs calculated to evaluate the strength of any association.
Measured: During inpatient stay up to 3 months after surgery
Evaluation for Wound infection or Delayed Wound Healing
This criterion will be assessed via the "Wound Check Form" which uses a scale from 1-9 with worsening wound healing and infection indicated by an increased score. Modifiers A and B indicating cellulitis and purulence respectively are also added to the scale. The worst score on this scale would therefore be a 9AB, and a perfectly healed wound would be score of 1.
Measured: At 2 week wound check after surgery
Evaluation for Need for Psychiatric Consult or Neuropsychiatric Side Effects
This criterion will be initially assessed via EPIC documentation via daily assessment via Neurosurgery residents whether the patient has experienced severe new onset behavioral issues in the post-op period typically associated with steroids (agitation, psychosis, mania). This will be then categorized into a binary system determining either the presence or absence of new severe agitation, psychosis, or mania. In addition, at the post operative visit, the patient will fill out the 'Dexamethasone Symptom questionnaire' which is a standardized questionnaire recording binary presence vs no presence of a list of common subjective symptoms experienced by patients on chronic steroids (headache, changes in body habitus etc) which will additionally be recorded.
Measured: At 2 week follow up after surgery
Change in lymphocyte count and differential
Compared using the two-sample t-test. A general linear model will be used in the multivariable analysis to estimate the adjusted difference.
Measured: At baseline and 10-14 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start9 Jan 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Grade GliomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kimberly Bojanowski Hoang, Emory University
- Investigators
- Kimberly Hoang, MD, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132685
- Sponsor's protocol ID
- STUDY00003975
- Other IDs
- NCI-2023-04702, STUDY00003975, WINSHIP5678-22, P30CA138292
- Status last verified
- Jan 2026
- First submitted
- 6 Sep 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No