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Radiation

Reduced-Dose Radiotherapy + Temozolomide for Glioblastoma

Q: Are enrollment opportunities still being offered to potential participants of this clinical trial?

Clinicaltrials.gov attests that this medical trial is still actively recruiting participants, with it having been initially posted on June 3rd 2021 and most recently updated July 25th 2022.

Q: Has the Food & Drug Administration given its sanction to radiation treatments?

Even though there is limited evidence on Radiation's effectiveness, our team at Power still awarded it a score of 2 due to the amount of safety data collected in its Phase 2 trial.

Q: What medical conditions are typically treated with radiation therapy?

Through Radiation treatment, nitrosourea therapy, and the implementation of advance directives, refractory cases of advanced mycosis fungoides can be managed.

Q: Has there been any prior experimentation with Radiation therapies?

Currently, 207 clinical trials researching Radiation are being carried out with 24 of them in the final testing phase. Many studies take place around Seoul, Songpa but this medical research is happening in 4752 different venues globally.

Q: How many participants is this trial accepting at the present?

Affirmative. According to clinicaltrials.gov, this research is actively seeking participants; the initial posting date was June 3rd 2021 and it was most recently updated on July 25th 2022. 38 patients must be recruited from a single medical centre for this trial to move forward.

Q: Does this research represent an unprecedented endeavor?

Since 2002, Radiation has been subjected to rigorous clinical testing. The initial research was funded by Schering-Plough and involved 60 patients. Following the completion of Phase 1 trials, it recieved approval for phase 2 in 2002. Currently, 207 active trials are being conducted across 36 different countries with 935 participating cities.

Phase 2

Recruiting

Led By Michael Straza, MD, PhD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky Performance Status Scale ≥ 70.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six months

Awards & highlights

Study Summary

This trial is testing whether a lower dose of radiation therapy is just as effective as the standard dose in treating glioblastoma.

Who is the study for?

Adults diagnosed with new glioblastoma who've had surgery, if needed, and are set for standard chemo-radiotherapy. They should have a life expectancy of over three months, stable health without severe illnesses or prior invasive cancers (except certain skin cancers), and agree to contraception if applicable. Patients can't join if they have recurrent brain tumors, other cancer sites, recent heart issues, connective tissue diseases at high risk for radiation toxicity, kidney failure requiring dialysis, or pregnancy.Check my eligibility

What is being tested?

The trial is testing pulsed reduced dose radiotherapy (pRDR) as an alternative to standard radiation therapy in combination with Temozolomide chemotherapy for the initial treatment of glioblastoma. The goal is to see how this approach affects disease progression compared to the current standard treatment.See study design

What are the potential side effects?

Potential side effects include those common to radiation therapy such as fatigue, hair loss at the treated site, headaches and nausea; and those related to Temozolomide like tiredness, constipation or diarrhea, loss of appetite and risk of infections due to lowered blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself but may not be able to do active work.

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I am set to receive a specific radiation and chemotherapy plan and haven't had other cancer treatments before joining.

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I am scheduled for a specific chemotherapy regimen.

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I am set to receive a specific radiation and chemotherapy plan and haven't had other cancer treatments before this.

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I have been postmenopausal for at least one year.

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My diagnosis is a new case of GBM, confirmed by tissue analysis.

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My tumor is located in the upper part of my brain.

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It has been over three weeks since my brain surgery.

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My recent blood test shows I have enough white blood cells, platelets, and hemoglobin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ six months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six months

This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Death

Progression-free survival

Side effects data

From 2008 Phase 3 trial • 243 Patients • NCT00216125

60%

NEUTROPHILS/GRANULOCYTES (ANC/AGC)

54%

LEUKOCYTES (TOTAL WBC)

51%

FATIGUE (ASTHENIA, LETHARGY, MALAISE)

48%

DYSPNEA (SHORTNESS OF BREATH)

43%

ESOPHAGITIS

38%

NAUSEA

36%

HEMOGLOBIN

35%

HAIR LOSS/ALOPECIA (SCALP OR BODY)

35%

COUGH

33%

PAIN

32%

ANOREXIA

31%

PAIN - OTHER (SPECIFY, __)

29%

PLATELETS

26%

VOMITING

26%

CONSTIPATION

24%

DIARRHEA

19%

MOOD ALTERATION

18%

NEUROPATHY: SENSORY

18%

INFECTION - OTHER (SPECIFY, __)

18%

WEIGHT LOSS

17%

DIZZINESS

15%

FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)

15%

PNEUMONITIS/PULMONARY INFILTRATES

15%

HEARTBURN/DYSPEPSIA

13%

INSOMNIA

13%

INFECTION - OTHER

12%

FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)

12%

GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)

11%

DEHYDRATION

11%

GASTROINTESTINAL - OTHER (SPECIFY, __)

11%

HYPOTENSION

10%

LYMPHOPENIA

10%

HEMORRHAGE, PULMONARY/UPPER RESPIRATORY

10%

RASH/DESQUAMATION

10%

RASH: DERMATITIS ASSOCIATED WITH RADIATION

MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC)

CARDIAC GENERAL - OTHER (SPECIFY, __)

ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)

ALKALINE PHOSPHATASE

PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)

MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY)

SWEATING (DIAPHORESIS)

SODIUM, SERUM-LOW (HYPONATREMIA)

VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)

POTASSIUM, SERUM-LOW (HYPOKALEMIA)

SUPRAVENTRICULAR AND NODAL ARRHYTHMIA

CALCIUM, SERUM-LOW (HYPOCALCEMIA)

AUDITORY/EAR - OTHER (SPECIFY, __)

SYNCOPE (FAINTING)

METABOLIC/LABORATORY - OTHER (SPECIFY, __)

CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)

HICCOUGHS (HICCUPS, SINGULTUS)

CREATININE

PLEURAL EFFUSION (NON-MALIGNANT)

CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)

HYPERTENSION

MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)

BLOOD/BONE MARROW - OTHER (SPECIFY, __)

POTASSIUM, SERUM-HIGH (HYPERKALEMIA)

THROMBOSIS/THROMBUS/EMBOLISM

HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)

RIGORS/CHILLS

DERMATOLOGY/SKIN - OTHER (SPECIFY, __)

MUCOSITIS/STOMATITIS (CLINICAL EXAM)

NEUROPATHY: MOTOR

HYPOXIA

COAGULATION - OTHER (SPECIFY, __)

URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)

HEMORRHAGE/BLEEDING - OTHER

EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS

HEMORRHAGE/BLEEDING - OTHER (SPECIFY, __)

PERICARDIAL EFFUSION (NON-MALIGNANT)

BICARBONATE, SERUM-LOW

RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)

ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)

ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)

MEMORY IMPAIRMENT

OCULAR/VISUAL - OTHER (SPECIFY, __)

RENAL/GENITOURINARY - OTHER

URINARY FREQUENCY/URGENCY

HOT FLASHES/FLUSHES

CARDIAC ARRHYTHMIA - OTHER (SPECIFY, __)

GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)

COLITIS

CARDIAC ARRHYTHMIA - OTHER

CONSTITUTIONAL SYMPTOMS - OTHER

DYSPHAGIA (DIFFICULTY SWALLOWING)

AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)

BLOOD/BONE MARROW - OTHER

URIC ACID, SERUM-HIGH (HYPERURICEMIA)

INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)

VENTRICULAR ARRHYTHMIA

LYMPHATICS - OTHER (SPECIFY, __)

FISTULA, GI

PRURITUS/ITCHING

WATERY EYE (EPIPHORA, TEARING)

SODIUM, SERUM-HIGH (HYPERNATREMIA)

SEIZURE

ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)

CALCIUM, SERUM-HIGH (HYPERCALCEMIA)

HEMORRHAGE, GI

MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __)

PHOTOSENSITIVITY

PULMONARY FIBROSIS (RADIOGRAPHIC CHANGES)

WEIGHT GAIN

PAIN - OTHER

HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM

PULMONARY/UPPER RESPIRATORY - OTHER

ALKALOSIS (METABOLIC OR RESPIRATORY)

CUSHINGOID APPEARANCE (E.G., MOON FACE, BUFFALO HUMP, CENTRIPETAL OBESITY, CUTANEOUS STRIAE)

SYNDROMES - OTHER (SPECIFY, __)

ARTHRITIS (NON-SEPTIC)

BILIRUBIN (HYPERBILIRUBINEMIA)

DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)

INFECTION WITH UNKNOWN ANC

INJECTION SITE REACTION/EXTRAVASATION CHANGES

GASTROINTESTINAL - OTHER

GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)

HYPOPIGMENTATION

NAIL CHANGES

100%

80%

60%

40%

20%

Study treatment Arm

Consolidation Docetaxel

Observation Only

Pre-Randomization

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pulsed reduced dose-rate radiotherapyExperimental Treatment3 Interventions

Chemoradiation, adjuvant chemotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation

2003

Completed Phase 3

~1020

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,545 Total Patients Enrolled

3 Trials studying Glioblastoma

116 Patients Enrolled for Glioblastoma

Michael Straza, MD, PhDPrincipal Investigator - Medical College of Wisconsin

Froedtert & The Medical College of Wisconsin

Media Library

pulsed reduced dose radiotherapy (pRDR) (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT04747145 — Phase 2

Glioblastoma Research Study Groups: Pulsed reduced dose-rate radiotherapy

Glioblastoma Clinical Trial 2023: pulsed reduced dose radiotherapy (pRDR) Highlights & Side Effects. Trial Name: NCT04747145 — Phase 2

pulsed reduced dose radiotherapy (pRDR) (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04747145 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment opportunities still being offered to potential participants of this clinical trial?

"Clinicaltrials.gov attests that this medical trial is still actively recruiting participants, with it having been initially posted on June 3rd 2021 and most recently updated July 25th 2022."

Answered by AI

Has the Food & Drug Administration given its sanction to radiation treatments?

"Even though there is limited evidence on Radiation's effectiveness, our team at Power still awarded it a score of 2 due to the amount of safety data collected in its Phase 2 trial."

Answered by AI

What medical conditions are typically treated with radiation therapy?

"Through Radiation treatment, nitrosourea therapy, and the implementation of advance directives, refractory cases of advanced mycosis fungoides can be managed."

Answered by AI

Has there been any prior experimentation with Radiation therapies?

"Currently, 207 clinical trials researching Radiation are being carried out with 24 of them in the final testing phase. Many studies take place around Seoul, Songpa but this medical research is happening in 4752 different venues globally."

Answered by AI

How many participants is this trial accepting at the present?

"Affirmative. According to clinicaltrials.gov, this research is actively seeking participants; the initial posting date was June 3rd 2021 and it was most recently updated on July 25th 2022. 38 patients must be recruited from a single medical centre for this trial to move forward."

Answered by AI

Does this research represent an unprecedented endeavor?

"Since 2002, Radiation has been subjected to rigorous clinical testing. The initial research was funded by Schering-Plough and involved 60 patients. Following the completion of Phase 1 trials, it recieved approval for phase 2 in 2002. Currently, 207 active trials are being conducted across 36 different countries with 935 participating cities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma

Michael Straza, MD, PhD 2021. "Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04747145.

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