Radiation

Radiation 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 the<a href="https://www.withpower.com/clinical-trials/ra">ra</a>py, 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.

Medical College of Wisconsin, Milwaukee, WI

Radiation +2 morePhase 2RecruitingLed by Michael Straza, MD, PhDResearch Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

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

Must have

Life expectancy greater than at least three months.

Supratentorial tumor location.

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upsix months

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Study Summary

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

Eligibility Criteria

Inclusion Criteria

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

Select...

You are expected to live for at least three more months.

Select...

The tumor is located in the upper part of the brain.

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%

COUGH

35%

HAIR LOSS/ALOPECIA (SCALP OR BODY)

33%

PAIN

32%

ANOREXIA

31%

PAIN - OTHER (SPECIFY, __)

29%

PLATELETS

26%

VOMITING

26%

CONSTIPATION

24%

DIARRHEA

19%

MOOD ALTERATION

18%

WEIGHT LOSS

18%

INFECTION - OTHER (SPECIFY, __)

18%

NEUROPATHY: SENSORY

17%

DIZZINESS

15%

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

15%

PNEUMONITIS/PULMONARY INFILTRATES

15%

HEARTBURN/DYSPEPSIA

13%

INFECTION - OTHER

13%

INSOMNIA

12%

GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)

12%

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

11%

DEHYDRATION

11%

GASTROINTESTINAL - OTHER (SPECIFY, __)

11%

HYPOTENSION

10%

HEMORRHAGE, PULMONARY/UPPER RESPIRATORY

10%

RASH/DESQUAMATION

10%

RASH: DERMATITIS ASSOCIATED WITH RADIATION

10%

LYMPHOPENIA

ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)

CARDIAC GENERAL - OTHER (SPECIFY, __)

MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC)

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)

CALCIUM, SERUM-LOW (HYPOCALCEMIA)

POTASSIUM, SERUM-LOW (HYPOKALEMIA)

SUPRAVENTRICULAR AND NODAL ARRHYTHMIA

AUDITORY/EAR - OTHER (SPECIFY, __)

SYNCOPE (FAINTING)

METABOLIC/LABORATORY - OTHER (SPECIFY, __)

CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)

CREATININE

PLEURAL EFFUSION (NON-MALIGNANT)

HICCOUGHS (HICCUPS, SINGULTUS)

BLOOD/BONE MARROW - OTHER (SPECIFY, __)

POTASSIUM, SERUM-HIGH (HYPERKALEMIA)

THROMBOSIS/THROMBUS/EMBOLISM

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

RIGORS/CHILLS

CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)

DERMATOLOGY/SKIN - OTHER (SPECIFY, __)

HYPERTENSION

MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)

MUCOSITIS/STOMATITIS (CLINICAL EXAM)

NEUROPATHY: MOTOR

HEMORRHAGE/BLEEDING - OTHER

COAGULATION - OTHER (SPECIFY, __)

EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS

HEMORRHAGE/BLEEDING - OTHER (SPECIFY, __)

PERICARDIAL EFFUSION (NON-MALIGNANT)

BICARBONATE, SERUM-LOW

HYPOXIA

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

URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)

RENAL/GENITOURINARY - OTHER

SEIZURE

ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)

CALCIUM, SERUM-HIGH (HYPERCALCEMIA)

CARDIAC ARRHYTHMIA - OTHER (SPECIFY, __)

COLITIS

HEMORRHAGE, GI

MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __)

PHOTOSENSITIVITY

PRURITUS/ITCHING

PULMONARY FIBROSIS (RADIOGRAPHIC CHANGES)

WATERY EYE (EPIPHORA, TEARING)

WEIGHT GAIN

PAIN - OTHER

CONSTITUTIONAL SYMPTOMS - OTHER

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

BLOOD/BONE MARROW - OTHER

CARDIAC ARRHYTHMIA - OTHER

FISTULA, GI

PULMONARY/UPPER RESPIRATORY - OTHER

ALKALOSIS (METABOLIC OR RESPIRATORY)

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

INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)

SYNDROMES - OTHER (SPECIFY, __)

ARTHRITIS (NON-SEPTIC)

BILIRUBIN (HYPERBILIRUBINEMIA)

DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)

INFECTION WITH UNKNOWN ANC

INJECTION SITE REACTION/EXTRAVASATION CHANGES

GASTROINTESTINAL - OTHER

DYSPHAGIA (DIFFICULTY SWALLOWING)

GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)

HYPOPIGMENTATION

SODIUM, SERUM-HIGH (HYPERNATREMIA)

AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)

GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)

HOT FLASHES/FLUSHES

LYMPHATICS - OTHER (SPECIFY, __)

NAIL CHANGES

OCULAR/VISUAL - OTHER (SPECIFY, __)

URIC ACID, SERUM-HIGH (HYPERURICEMIA)

URINARY FREQUENCY/URGENCY

VENTRICULAR ARRHYTHMIA

100%

80%

60%

40%

20%

Study treatment Arm

Consolidation Docetaxel

Observation Only

Pre-Randomization

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2005

Completed Phase 3

~990

0 / 2Eligibility criteria met

Find a site

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

594 Previous Clinical Trials

1,160,869 Total Patients Enrolled

3 Trials studying Glioblastoma

104 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.