Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma

  • STATUS
    Recruiting
  • End date
    Jun 18, 2026
  • participants needed
    38
  • sponsor
    Medical College of Wisconsin
Updated on 18 July 2021
corticosteroids
karnofsky performance status
cytotoxic chemotherapy
chemoradiotherapy
neutrophil count
complete resection
temozolomide
gross total resection

Summary

The primary protocol objective is to assess the impact of substituting pulsed reduced dose radiotherapy (pRDR) for standard radiation therapy in the upfront treatment of glioblastoma (GBM) on disease progression.

Description

This is a single-arm, single-center phase 2 study designed to assess the efficacy of pulsed reduced dose-rate radiotherapy in the initial treatment of maximally safely resected glioblastoma. The primary endpoint will be progression-free survival at six months. Patients with pathologically confirmed GBM who are planned for six weeks of adjuvant chemoradiation followed by six to12 months of adjuvant chemotherapy will be screened and enrolled after surgery.

Details
Condition Glioblastoma Multiforme, glioblastoma
Treatment Radiation, Concurrent Chemotherapy (Temozolomide), Adjuvant Chemotherapy (Temozolomide)
Clinical Study IdentifierNCT04747145
SponsorMedical College of Wisconsin
Last Modified on18 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Voluntary written consent must be given before performance of any study-related procedure that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Female or male subjects 18 years old at the time of informed consent
Histologically confirmed new diagnosis of GBM according to updated World Health Organization (WHO) classification criteria
Supratentorial tumor location
Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection and biopsy-only patients are all acceptable)
Planned for standard adjuvant chemoradiotherapy of approximately 60 Gy of radiation therapy (RT) , or biologically equivalent dose, according to local practice, and concomitant TMZ chemotherapy (75 mg/m^2 daily) Any other cytotoxic or biologic antitumor therapy received prior to enrollment will be considered an exclusion
Planned treatment with adjuvant/maintenance TMZ (150 to 200 mg/m^2 daily x 5 d, q 28 days)
All patients with sufficient tissue must have had tissue submitted for O6-Methylguanine-DNA Methyltransferase (MGMT) promoter methylation determination prior to enrollment
Karnofsky Performance Status Scale 70
Life expectancy greater than at least three months
Study start date at least three weeks out from brain surgery
Stable or decreasing dose of corticosteroids for the last seven days prior to enrollment, if applicable
Complete blood count (CBC) /differential obtained within 28 days prior to registration, with adequate bone marrow function defined as follows: absolute neutrophil count (ANC) 1,500 cells/mm^3; platelets 100,000 cells/mm^3; hemoglobin 10.0 g/dL. (Note: the use of transfusion or other intervention to achieve Hgb 10.0 g/dL is acceptable.)
Female subjects who
Are postmenopausal for at least one year before the screening visit, OR
Are surgically sterile, OR
If they are of childbearing potential
i. Agree to practice one highly effective method and one additional effective
(barrier) method of contraception, at the same time, from the time of signing
the informed consent through four months after the last study intervention
(female and male condoms should not be used together), OR ii. Agree to
practice true abstinence, when this is in line with the preferred and usual
lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation
symptothermal, postovulation methods] withdrawal, spermicides only, and
lactational amenorrhea are not acceptable methods of contraception.)
\. Male subjects, even if surgically sterilized (i.e., status
postvasectomy), who
Agree to practice effective barrier contraception during the entire study treatment period from the time of signing the informed consent through four months after the last study intervention (female and male condoms should not be used together), OR
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.)

Exclusion Criteria

Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of three years. (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
Recurrent or multifocal malignant gliomas
Any site of distant disease (i.e., leptomeningeal disease or drop metastases from the GBM tumor site)
Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
Severe, active comorbidity, defined as follows
Unstable angina at registration
Transmural myocardial infarction within the last six months prior to registration
Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of 2 mm using the analysis of an EKG performed within 28 days prior to registration. (Note: EKG to be performed only if clinical suspicion of cardiac issue.)
New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to
Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity
New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration
Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity
End-stage renal disease (i.e., on dialysis or dialysis has been recommended)
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
Patents treated on any other therapeutic clinical protocols within 30 days prior to registration
Inability to undergo MRI
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