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Radiation + Temozolomide for Glioblastoma

Phase 1 & 2
Recruiting
Led By Shiao Woo, MD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have normal organ and marrow function: Leukocytes > 3,000/microliter, Absolute neutrophil count > 1,500/microliter, Platelets > 100,000/microliter, Total bilirubin within normal institutional limits, aspartate aminotransferase test(SGOT)/alanine aminotransferase test(SGPT) < 2.5 X institutional upper limit of normal, Creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal, Ability to understand and the willingness to sign a written informed consent document
Participants must have histologically confirmed glioblastoma/gliosarcoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study enrollment to date of death or up to approximately 5 years
Awards & highlights

Study Summary

This trial will study the effects of radiation and temozolomide on patients over 70 with cancer.

Who is the study for?
This trial is for patients over 70 with newly diagnosed glioblastoma who haven't had prior treatments. They must have a life expectancy of more than 6 months, good organ and marrow function, and be able to consent. Excluded are those with other cancers (unless low risk or certain types within the past 5 years), severe illnesses, or HIV on antiretrovirals.Check my eligibility
What is being tested?
The study tests a combination of short-term radiation therapy (over two weeks) and Temozolomide chemotherapy during and after radiation in older adults. The goal is to see how well they tolerate this treatment regimen and its effectiveness against their brain cancer.See study design
What are the potential side effects?
Temozolomide may cause nausea, vomiting, fatigue, constipation, loss of appetite or hair loss. Radiation could lead to headaches, scalp irritation or cognitive changes. Side effects vary by individual; some might experience few while others more.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diagnosis is glioblastoma or gliosarcoma confirmed by tissue analysis.
Select...
My tumor's MGMT promoter methylation status has been checked.
Select...
I am over 70 years old.
Select...
I am mostly independent and can care for myself.
Select...
I have not received any treatment for glioblastoma multiforme.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study enrollment to date of death or up to approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study enrollment to date of death or up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients who stop treatment due to CTCAE grade 3 or above toxicities
Secondary outcome measures
Overall survival
Quality of Life
The number of patients to complete RT+TMZ and a minimum of 3 of the 6 planned cycles of adjuvant chemotherapy

Side effects data

From 2016 Phase 2 trial • 175 Patients • NCT01055314
36%
Febrile neutropenia
31%
Death NOS
30%
Diarrhea
22%
Pain
21%
Hyperglycemia
16%
Anorexia
16%
Infections and infestations - Other, specify
16%
Alanine aminotransferase increased
14%
Hypokalemia
13%
Nausea
11%
Hyponatremia
10%
Weight loss
9%
Aspartate aminotransferase increased
9%
Anemia
9%
Mucositis oral
9%
Vomiting
9%
Constipation
9%
Dehydration
9%
Hypophosphatemia
8%
Platelet count decreased
8%
Sepsis
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Catheter related infection
7%
Colitis
7%
Abdominal pain
6%
Hypotension
6%
White blood cell decreased
6%
GGT increased
6%
Hypocalcemia
6%
Urinary retention
6%
Hypoalbuminemia
6%
Fever
5%
Anxiety
5%
Typhlitis
5%
Neutrophil count decreased
5%
Urinary tract infection
4%
Peripheral motor neuropathy
4%
Enterocolitis
4%
Lipase increased
4%
Pleural effusion
4%
Serum amylase increased
4%
Skin infection
4%
Epistaxis
4%
Urinary tract obstruction
3%
Lymphocyte count decreased
3%
Wound infection
3%
Blood bilirubin increased
3%
Syncope
3%
Dermatitis radiation
3%
Hypertension
3%
Sinus tachycardia
3%
Edema limbs
3%
Bone pain
3%
Dyspnea
3%
Hematuria
3%
Hypercalcemia
2%
Thromboembolic event
2%
Upper gastrointestinal hemorrhage
2%
Vulval infection
2%
Depressed level of consciousness
2%
Stridor
2%
Allergic reaction
2%
Back pain
2%
Lung infection
2%
Urticaria
2%
Acute kidney injury
2%
Muscle weakness lower limb
2%
Musculoskeletal and connective tissue disorder - Other, specify
2%
Pain in extremity
2%
Peripheral sensory neuropathy
2%
Proctitis
2%
Skin ulceration
2%
Apnea
2%
Stoma site infection
2%
Tumor pain
2%
Left ventricular systolic dysfunction
2%
Pancreatitis
2%
Portal hypertension
2%
Rectal hemorrhage
2%
Creatinine increased
2%
Enterocolitis infectious
2%
Hyperkalemia
2%
Investigations - Other, specify
2%
Abdominal distension
1%
Esophageal pain
1%
Gastrointestinal disorders - Other, specify
1%
Heart failure
1%
Hepatobiliary disorders - Other, specify
1%
Penile pain
1%
Vascular disorders - Other, specify
1%
Ascites
1%
Bone marrow hypocellular
1%
Anaphylaxis
1%
Delirium
1%
Sore throat
1%
Vasovagal reaction
1%
Anal hemorrhage
1%
Soft tissue infection
1%
Tracheitis
1%
Anal mucositis
1%
Seizure
1%
Menorrhagia
1%
Fracture
1%
Hydrocephalus
1%
Device related infection
1%
Tooth infection
1%
Gastric ulcer
1%
Sinusitis
1%
Skin and subcutaneous tissue disorders - Other, specify
1%
Pharyngitis
1%
Pyramidal tract syndrome
1%
Anal ulcer
1%
Depression
1%
Ejection fraction decreased
1%
Rash maculo-papular
1%
Pruritus
1%
Myositis
1%
Nail infection
1%
Pain of skin
1%
Pleuritic pain
1%
Pneumonitis
1%
Pneumothorax
1%
Postoperative hemorrhage
1%
Renal and urinary disorders - Other, specify
1%
Respiratory, thoracic and mediastinal disorders - Other, specify
1%
Salivary duct inflammation
1%
Small intestine infection
1%
Alkaline phosphatase increased
1%
Appendicitis
1%
Spinal fracture
1%
Disseminated intravascular coagulation
1%
Ear and labyrinth disorders - Other, specify
1%
Endocrine disorders - Other, specify
1%
Esophageal stenosis
1%
Esophagitis
1%
Gastric hemorrhage
1%
Gum infection
1%
Tumor lysis syndrome
1%
Upper respiratory infection
1%
Hypertriglyceridemia
1%
Hypoxia
1%
Ileus
1%
INR increased
1%
Laryngeal edema
1%
Multi-organ failure
1%
Myelodysplastic syndrome
1%
Oral hemorrhage
1%
Oral pain
1%
Pulmonary edema
1%
Rectal fistula
1%
Rectal pain
1%
Respiratory failure
1%
Bladder spasm
1%
Chest wall pain
1%
Confusion
1%
Congenital, familial and genetic disorders - Other, specify
1%
CPK increased
1%
Dizziness
1%
Encephalopathy
1%
Eye disorders - Other, specify
1%
Generalized muscle weakness
1%
Hoarseness
1%
Hypernatremia
1%
Hypoglycemia
1%
Hypomagnesemia
1%
Insomnia
1%
Irregular menstruation
1%
Irritability
1%
Joint range of motion decreased cervical spine
1%
Kyphosis
1%
Lethargy
1%
Headache
1%
Laryngeal mucositis
1%
Pelvic pain
1%
Esophageal infection
1%
Abdominal infection
1%
Acidosis
1%
Anal fistula
1%
Fall
1%
Fatigue
1%
Gait disturbance
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)
Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hypofractionated radiotherapy and temozolomideExperimental Treatment2 Interventions
All subjects will receive treatment as is a single arm study. Two weeks of combined hypofractionated radiotherapy with concurrent temozolomide followed by up to 6 cycles of adjuvant temozolomide treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated radiotherapy
2015
Completed Phase 3
~510
Temozolomide
FDA approved

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
339 Previous Clinical Trials
76,640 Total Patients Enrolled
1 Trials studying Glioblastoma
30 Patients Enrolled for Glioblastoma
James Graham Brown Cancer CenterOTHER
43 Previous Clinical Trials
9,178 Total Patients Enrolled
Shiao Woo, MDPrincipal InvestigatorJames Graham Brown Cancer Center

Media Library

Hypofractionated radiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT01985087 — Phase 1 & 2
Glioblastoma Research Study Groups: Hypofractionated radiotherapy and temozolomide
Glioblastoma Clinical Trial 2023: Hypofractionated radiotherapy Highlights & Side Effects. Trial Name: NCT01985087 — Phase 1 & 2
Hypofractionated radiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01985087 — Phase 1 & 2

Frequently Asked Questions

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

Are there any openings left in this medical trial?

"As per the information stored on clinicaltrials.gov, enrollment for this medical trial is ongoing. The inaugural posting of the study was on September 1st 2014, with updates to its content made as recently as October 22nd 2021."

Answered by AI

Would you consider this clinical trial to be a pioneering endeavor?

"Since 2002, Temozolomide has been the subject of a variety of medical studies. The initial trial was sponsored by Schering-Plough and enrolled 60 patients; after this first study, Phase 2 approval was granted for the drug's use. As it currently stands, 207 active investigations into its efficacy are taking place across 935 cities in 36 countries worldwide."

Answered by AI

What medical conditions often necessitate the utilization of Temozolomide?

"Temozolomide is often prescribed to treat nitrosourea-resistant conditions, such as refractory mycosis fungoides, advanced directives and neuroblastoma."

Answered by AI

Are there any other research initiatives that have explored the use of Temozolomide?

"Presently, 207 distinct clinical trials are exploring Temozolomide as a treatment. Of those studies, 24 are in Phase 3. While most of these research sites reside in Seoul and Songpa, an additional 4752 locations have been identified for conducting the trial."

Answered by AI

What is the current recruitment rate for this research project?

"Confirmed. According to the clinicaltrials.gov website, this research project is open for enrollment and was initially posted on September 1st 2014. It has since been reviewed and updated as recently as October 22nd 2021. The study requires 40 participants from a single medical facility in order to meet its goals."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
How old are they?
65+
What site did they apply to?
James Graham Brown Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study Using Radiation Therapy and Temozolomide to Treat Glioblastoma in Patients Over 70
Shiao Yuo Woo,M.D. 2014. "A Study Using Radiation Therapy and Temozolomide to Treat Glioblastoma in Patients Over 70". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01985087.
All > Glioblastoma Cincinnati > Kentucky
~4 spots leftby May 2025
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