Temporally-modulated Pulsed Radiation Therapy (TMPRT) After Prior EBRT for Recurrent IDH-mutant Gliomas

Brief Title

Temporally-modulated Pulsed Radiation Therapy (TMPRT) After Prior EBRT for Recurrent IDH-mutant Gliomas

Official Title

A Pilot Study of Temporally-modulated Pulsed Radiation Therapy to Reirradiate Recurrent IDH-mutant Gliomas After Prior External Beam Radiation Therapy

Brief Summary

      This clinical trial studies the side effects of temporally-modulated pulsed radiation therapy
      (TMPRT) in patients with IDH-mutant gliomas who have previously received radiation therapy to
      the brain. TMPRT is a radiation technique in which radiation is delivered in multiple small
      doses on a specific timed interval, instead of delivering one large dose at one time. This
      technique may improve efficacy while reducing toxicity and improving patient quality of life.
    

Study Type

Interventional

Primary Outcome

Frequency of intolerable toxicities

Secondary Outcome

 Change in symptom burden as measured by M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)

Condition

Astrocytoma

Intervention

temporally-modulated pulsed radiotherapy (TMPRT)

Study Arms / Comparison Groups

 Arm 1: temporally-modulated pulsed radiotherapy (TMPRT)

Description:  Patients receive TMPRT daily as 10 pulses of 0.2 Gy each with a 3-minute interval between pulses (effective dose rate = 0.0667 Gy/min) to a total dose of 54 Gy at 2 Gy per day. Treatment continues for a total of 27 fractions in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Radiation

Estimated Enrollment

12

Start Date

August 31, 2022

Completion Date

August 31, 2027

Primary Completion Date

August 31, 2027

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed recurrent IDH-mutant gliomas (either astrocytoma or
             oligodendroglioma) with prior external beam radiation therapy (EBRT) to the same
             region. The recurrent tumor may be either histologically confirmed or based on
             clinical assessment. Any lesion size or any number of prior recurrences are allowed.

          -  Prior EBRT is ≥ 2 years ago.

          -  The region for reirradiation should have received at least 45 Gy from the prior EBRT
             but no more than 75 Gy. The prior EBRT could be either photon-based or proton-based.

          -  Prior SRS to the same region is permitted as long as the cumulative dose of EBRT plus
             SRS is no more than 75 Gy. The prior SRS should be completed at least 6 months ago.

          -  Life expectancy ≥ 12 months

          -  At least 18 years of age.

          -  Karnofsky performance status (KPS) of at least 70%.

          -  Females of childbearing potential (defined as a female who is non-menopausal or
             surgically sterilized) must be willing to use an acceptable method of birth control
             (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom
             with spermicide, or abstinence) for the duration of the study. Should a woman become
             pregnant or suspect she is pregnant while participating in this study, she must inform
             her treating physician immediately.

          -  Able to understand and willing to sign an IRB-approved written informed consent
             document (legally authorized representative permitted).

        Exclusion Criteria:

          -  Leptomeningeal or metastatic involvement.

          -  Use of concurrent bevacizumab or other anti-VEGF-directed therapy during TMPRT is not
             allowed. If the patient is on bevacizumab, the patient needs to discontinue
             bevacizumab for at least 4 weeks prior to the start of TMPRT and remain stable. Other
             chemotherapy, immunotherapy, or target therapy can be used concurrently or adjuvantly
             at the discretion of treating physician.

          -  Medical contraindication to MRI (e.g., unsafe foreign metallic implants, incompatible
             pacemaker, inability to lie still for long periods, severe to end-stage kidney disease
             or on hemodialysis).

          -  Pregnant.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jiayi Huang, M.D., 314-273-2931, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT05393258

Organization ID

202205105

Responsible Party

Sponsor

Study Sponsor

Washington University School of Medicine

Study Sponsor

Jiayi Huang, M.D., Principal Investigator, Washington University School of Medicine

Verification Date

June 2022