We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04747145
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : July 27, 2022
Sponsor:
Information provided by (Responsible Party):
Michael Straza, MD, PhD, Medical College of Wisconsin

Brief 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.

Condition or disease Intervention/treatment Phase
Glioblastoma Device: Radiation Drug: Concurrent Chemotherapy (Temozolomide) Drug: Adjuvant Chemotherapy (Temozolomide) Phase 2

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma (PRORADGLIO Study)
Actual Study Start Date : June 3, 2021
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pulsed reduced dose-rate radiotherapy
Chemoradiation, adjuvant chemotherapy.
Device: Radiation
60 Gy to be delivered over 30 daily treatments in six weeks. Chemoradiation is to start no sooner than 3 weeks after surgery and not later than 8 weeks.
Other Names:
  • Pulsed Reduced Dose Radiotherapy
  • pRDR

Drug: Concurrent Chemotherapy (Temozolomide)
75mg/m^2 x 42 days (concurrent chemotherapy with radiation). Chemoradiation is to start no sooner than 3 weeks after surgery and not later than 8 weeks.
Other Names:
  • TMZ
  • Temodar

Drug: Adjuvant Chemotherapy (Temozolomide)
Starting no sooner than 4 weeks after completion of chemoradiation, 150-200mg/m^2, days 1-5 of 28-day cycle, for minimum of six cycles and up to 12 cycles.
Other Names:
  • TMZ
  • Temodar




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Six months ]
    This outcome measure is the number of subjects whose disease has not progressed using the Macdonald Response Criteria, which has the following classifications: complete response, partial response, stable disease and progression.

  2. Death [ Time Frame: Six months ]
    This outcome measure is the number of subjects expiring from any cause.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Female or male subjects ≥ 18 years old at the time of informed consent.
  3. Histologically confirmed new diagnosis of GBM according to updated World Health Organization (WHO) classification criteria.
  4. Supratentorial tumor location.
  5. Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection and biopsy-only patients are all acceptable).
  6. 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.
  7. Planned treatment with adjuvant/maintenance TMZ (150 to 200 mg/m^2 daily x 5 d, q 28 days).
  8. All patients with sufficient tissue must have had tissue submitted for O6-Methylguanine-DNA Methyltransferase (MGMT) promoter methylation determination prior to enrollment.
  9. Karnofsky Performance Status Scale ≥ 70.
  10. Life expectancy greater than at least three months.
  11. Study start date at least three weeks out from brain surgery.
  12. Stable or decreasing dose of corticosteroids for the last seven days prior to enrollment, if applicable.
  13. 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.)
  14. Female subjects who:

    1. Are postmenopausal for at least one year before the screening visit, OR
    2. 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.)

  15. Male subjects, even if surgically sterilized (i.e., status postvasectomy), who:

    1. 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
    2. 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:

  1. 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).
  2. Recurrent or multifocal malignant gliomas.
  3. Any site of distant disease (i.e., leptomeningeal disease or drop metastases from the GBM tumor site).
  4. Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
  5. 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).
  6. 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.
  7. Patents treated on any other therapeutic clinical protocols within 30 days prior to registration.
  8. Inability to undergo MRI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04747145


Contacts
Layout table for location contacts
Contact: Medical College of Wisconsin Cancer Center Clinical Trials Office 414-805-8900 cccto@mcw.edu

Locations
Layout table for location information
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Michael Straza, MD, PhD    414-805-4400    mstraza@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Layout table for investigator information
Principal Investigator: Michael Straza, MD, PhD Medical College of Wisconsin
Layout table for additonal information
Responsible Party: Michael Straza, MD, PhD, Assistant Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT04747145    
Other Study ID Numbers: PRO00039277
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: July 27, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Michael Straza, MD, PhD, Medical College of Wisconsin:
pulsed reduced dose radiotherapy
glioblastoma
pRDR
Additional relevant MeSH terms:
Layout table for MeSH terms
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents