Radiation

Radiation for Glioblastoma

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

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
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You are expected to live for at least three more months.
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The tumor is located in the upper part of the brain.

Timeline

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
8%
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
8%
CARDIAC GENERAL - OTHER (SPECIFY, __)
8%
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC)
7%
ALKALINE PHOSPHATASE
7%
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
7%
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY)
7%
SWEATING (DIAPHORESIS)
7%
SODIUM, SERUM-LOW (HYPONATREMIA)
7%
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
6%
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
6%
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
6%
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA
6%
AUDITORY/EAR - OTHER (SPECIFY, __)
6%
SYNCOPE (FAINTING)
6%
METABOLIC/LABORATORY - OTHER (SPECIFY, __)
5%
CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)
5%
CREATININE
5%
PLEURAL EFFUSION (NON-MALIGNANT)
5%
HICCOUGHS (HICCUPS, SINGULTUS)
4%
BLOOD/BONE MARROW - OTHER (SPECIFY, __)
4%
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
4%
THROMBOSIS/THROMBUS/EMBOLISM
4%
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
4%
RIGORS/CHILLS
4%
CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)
4%
DERMATOLOGY/SKIN - OTHER (SPECIFY, __)
4%
HYPERTENSION
4%
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
4%
MUCOSITIS/STOMATITIS (CLINICAL EXAM)
4%
NEUROPATHY: MOTOR
2%
HEMORRHAGE/BLEEDING - OTHER
2%
COAGULATION - OTHER (SPECIFY, __)
2%
EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS
2%
HEMORRHAGE/BLEEDING - OTHER (SPECIFY, __)
2%
PERICARDIAL EFFUSION (NON-MALIGNANT)
2%
BICARBONATE, SERUM-LOW
2%
HYPOXIA
2%
RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)
2%
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
2%
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
2%
MEMORY IMPAIRMENT
2%
URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
1%
RENAL/GENITOURINARY - OTHER
1%
SEIZURE
1%
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
1%
CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
1%
CARDIAC ARRHYTHMIA - OTHER (SPECIFY, __)
1%
COLITIS
1%
HEMORRHAGE, GI
1%
MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __)
1%
PHOTOSENSITIVITY
1%
PRURITUS/ITCHING
1%
PULMONARY FIBROSIS (RADIOGRAPHIC CHANGES)
1%
WATERY EYE (EPIPHORA, TEARING)
1%
WEIGHT GAIN
1%
PAIN - OTHER
1%
CONSTITUTIONAL SYMPTOMS - OTHER
1%
HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM
1%
BLOOD/BONE MARROW - OTHER
1%
CARDIAC ARRHYTHMIA - OTHER
1%
FISTULA, GI
1%
PULMONARY/UPPER RESPIRATORY - OTHER
1%
ALKALOSIS (METABOLIC OR RESPIRATORY)
1%
CUSHINGOID APPEARANCE (E.G., MOON FACE, BUFFALO HUMP, CENTRIPETAL OBESITY, CUTANEOUS STRIAE)
1%
INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)
1%
SYNDROMES - OTHER (SPECIFY, __)
1%
ARTHRITIS (NON-SEPTIC)
1%
BILIRUBIN (HYPERBILIRUBINEMIA)
1%
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
1%
INFECTION WITH UNKNOWN ANC
1%
INJECTION SITE REACTION/EXTRAVASATION CHANGES
1%
GASTROINTESTINAL - OTHER
1%
DYSPHAGIA (DIFFICULTY SWALLOWING)
1%
GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)
1%
HYPOPIGMENTATION
1%
SODIUM, SERUM-HIGH (HYPERNATREMIA)
1%
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
1%
GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)
1%
HOT FLASHES/FLUSHES
1%
LYMPHATICS - OTHER (SPECIFY, __)
1%
NAIL CHANGES
1%
OCULAR/VISUAL - OTHER (SPECIFY, __)
1%
URIC ACID, SERUM-HIGH (HYPERURICEMIA)
1%
URINARY FREQUENCY/URGENCY
1%
VENTRICULAR ARRHYTHMIA
100%
80%
60%
40%
20%
0%
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

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
~15 spots leftby Jun 2025