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Radiation Therapy

Radiation for Glioblastoma

Q: What level of authorization has the Food and Drug Administration granted to radiation treatments?

<p>Our Power team has assigned radiation a safety score of 1 as this is a Phase 1 trial, meaning the data regarding its efficacy and security are still minimal.</p>

Q: Is recruitment ongoing for this investigation?

<p>Unfortunately, this research is not recruiting new participants. Initially posted on June 15th 2016 and last updated on October 6th 2022, the trial has since concluded - though 467 other studies remain open for enrolment.</p>

Phase 1

Waitlist Available

Led By Kevin A Camphausen, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month after completion of re-irradiation

Awards & highlights

Study Summary

This trial is testing the safety and highest tolerated dose of re-irradiation for people who have recurrent glioblastoma.

Eligible Conditions

Glioblastoma
Gliosarcoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month after completion of re-irradiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month after completion of re-irradiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month after completion of re-irradiation for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To determine maximum tolerated re-irradiation dose (MTD).

Secondary outcome measures

To determine QOL and impact on neurocognition in the setting of re-irradiation of recurrent glioblastoma

To determine late toxicity secondary to re-irradiation

To determine progression free survival and overall 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

RENAL/GENITOURINARY - OTHER

OCULAR/VISUAL - OTHER (SPECIFY, __)

HOT FLASHES/FLUSHES

CARDIAC ARRHYTHMIA - OTHER (SPECIFY, __)

COLITIS

GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)

URINARY FREQUENCY/URGENCY

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: 1/RadiationExperimental Treatment1 Intervention

Dose escalation is as follows: dose level 1 (DL1) 3.5 Gy x 10; dose level 2 (DL2) 3.5 Gy x 12; dose level 3 (DL3) 3.5 Gy x 14. If 2 DLTs are observed in the second dose level a step down dose of 3.0 Gy x 14 fractions will be tested. If 2 DLTs are observed in the third dose level a step down dose of 3.0 Gy x 17 fractions will be tested. The study will have 3 planned re-irradiation dose levels, with 1 to 6 patients per dose level using the 3+3 design to define the MTD. The number of patients may be increased to 9 total patients at the MTD ( provided no DLT) with a maximum of 21 evaluable patients enrolled.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation

2003

Completed Phase 3

~1020

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,661 Previous Clinical Trials

40,924,405 Total Patients Enrolled

322 Trials studying Glioblastoma

23,098 Patients Enrolled for Glioblastoma

Kevin A Camphausen, M.D.Principal InvestigatorNational Cancer Institute (NCI)

14 Previous Clinical Trials

3,264 Total Patients Enrolled

2 Trials studying Glioblastoma

224 Patients Enrolled for Glioblastoma

Frequently Asked Questions

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

What level of authorization has the Food and Drug Administration granted to radiation treatments?

"Our Power team has assigned radiation a safety score of 1 as this is a Phase 1 trial, meaning the data regarding its efficacy and security are still minimal."

Answered by AI

Is recruitment ongoing for this investigation?

"Unfortunately, this research is not recruiting new participants. Initially posted on June 15th 2016 and last updated on October 6th 2022, the trial has since concluded - though 467 other studies remain open for enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose Escalation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

2016. "Dose Escalation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02709226.