Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression

Daily dose of 2.0gy delivered in .2gy pulses for a total of 54gy over 5.5 weeks and 27 fractions. In the rare instance of the presence of extensive disease requiring essentially whole brain radiation, a total daily dose of 1.8 Gy delivered in .2 Gy pulses for 23 fractions to a total dose of 41.4 Gy will be utilized.

PRDR

Steve Howard, MD

H. Ian Robins, MD, Ph.D

To determine the efficacy of Pulse Reduced Dose Rate (PRDR) radiation when given in 27 fraction over 5.5 weeks with concurrent bevacizumab followed by adjuvant bevacizumab until time of progression in patients with recurrent high grade gliomas (grade III and grade IV). Patients will be placed in 1 of 4 groups based on their histologic diagnosis and prior exposure to bevacizumab.

A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab

time of first dose of PDRD+ Bevacizumab until time of death

time of first dose of PDRD+ Bevacizumab until time of death. All changes from baseline assessment will be recorded until 30 days post last dose of bevacizumab, assessed using the NCI CTCAE version 4.0 criteria.

Late toxicity that is likely attributable to re-irradiation or bevacizumab will be recorded.

Progression free survival (PFS) will be defined as the time from the first study treatment to the first occurrence of disease progression or death.

The MMSE survey is a clinician facilitated instrument scored on a scale of 0-30 where scores of 0-17 indicate severe cognitive impairment, 18-23 indicate mild cognitive impairment, and 24-30 indicate no cognitive impairment.

The Functional Assessment of Cancer Therapy - Brain (FACT-BR) instrument is a 50-item survey with each item scored on a 5 point likert scale where 0 is 'not at all' and 4 is 'very much'. The total possible range of scores is 0-200 where higher scores indicate higher quality of life.

The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) instrument is a 13-item survey with each item scored on a 5 point likert scale where 0 is 'not at all' and 4 is 'very much'. The total possible range of scores is from 0-52 where higher scores indicate better quality of life. A score of less than 30 indicates severe fatigue.

The Karnofsky Performance Status measures a cancer patient's ability to perform ordinary tasks. It is score from 0-100 where 0 means a person has died, less than 40 is various degrees of unable to care for oneself, 50-70 is unable to work but can care for personal needs with variable assistance, and 80-100 is able to carry on normal activity with variable symptoms of disease.

Genentech, Inc.

National Cancer Institute (NCI)

University of Wisconsin, Madison

Astrocytoma

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

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.

Radiation

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.

Concurrent 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.

Adjuvant Chemotherapy (Temozolomide)

Medical College of Wisconsin Cancer Center Clinical Trials Office

Michael Straza, MD, PhD

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.

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.

Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma

A Phase II Study Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma (PRORADGLIO Study)

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.

This outcome measure is the number of subjects expiring from any cause.

Medical College of Wisconsin

Assistant Professor

Symptoms and General Pathology

Nervous System Diseases

Recurrence

Central Nervous System Neoplasms

Nervous System Neoplasms

Disease Attributes

Proton pulsed reduced dose rate (PRDR) technique, to a dose of 54 Gy in 30 fractions (treatments) with proton radiotherapy. Treatments will occur once per day on consecutive weekdays.

Rupesh Kotecha, M.D.

Antoinette Pimental

Hina Saeed, M.D.

Robert Press, M.D.

The purpose of this research study is to see if a specific type of radiation therapy, called "proton pulsed reduced dose rate" or "PRDR radiotherapy" has any benefits at dose levels and number of fractions thought to be acceptable in earlier research studies. The researchers want to find out what effects (good and bad) PRDR has on people with cancer in the brain called a "recurrent high-grade glioma" meaning that it grows fast, can spread quickly, and it has come back or gotten worse after being treated previously.

PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial

PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies (POPCORN) Trial

PFS is defined as the duration of time from treatment start to first progressive disease (PD), date of death, or last follow-up date on which the patient was reported alive after proton PRDR reirradiation. Response to treatment will be assessed using Response Assessment in Neuro-Oncology (RANO).

The total number of AEs considered possibly, probably, or definitely related to proton PRDR as per the CTCAE v5.0.

OS is defined as the duration of time from treatment start to date of death, or last follow-up date on which the patient was reported alive after proton PRDR reirradiation.

The number of CNS AEs considered possibly, probably, or definitely related to proton PRDR as per CTCAE v5.0

Symptoms will be assessed using the MDASI-BT, which is a 28-item questionnaire that asks about cancer symptoms and how the symptoms interfere with daily life. Each item is scored on a 0-10 scale (0 = best, 10 = worst), with a total score of 0-280, with a higher score indicating worse symptoms.

QOL will be assessed using the EQ-5D-5L questionnaire. There are five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. There also is a visual analog scale asking about overall health that ranges from 0-100. Higher scores indicate better health and QOL.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab	NCT01743950	Glioma	Bevacizumab PRDR	18 Years -	University of Wisconsin, Madison
Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma	NCT04747145	Glioblastoma	Radiation Concurrent Chem... Adjuvant Chemot...	18 Years -	Medical College of Wisconsin
A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab	NCT01743950	Glioma	Bevacizumab PRDR	18 Years -	University of Wisconsin, Madison
PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial	NCT06397560	Glioma Glioma, Maligna... Recurrent Gliom...	PRDR	18 Years -	Baptist Health South Florida
A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab	NCT01743950	Glioma	Bevacizumab PRDR	18 Years -	University of Wisconsin, Madison

Spots Global Cancer Trial Database for prdr

Every month we try and update this database with for prdr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for prdr

Every month we try and update this database with for prdr cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for prdr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.