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CAPTEM for Glioblastoma (CAPTEM Trial)
CAPTEM Trial Summary
This trial will help researchers learn whether adding capecitabine to the standard oral temozolomide treatment for newly diagnosed GBM is safe and improves patient outcomes.
CAPTEM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCAPTEM Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 2 trial • 175 Patients • NCT01055314CAPTEM Trial Design
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Who is running the clinical trial?
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- I need assistance with my daily activities.I have heart disease and need a heart doctor's approval before starting capecitabine.I have had chemotherapy with capecitabine or temozolomide for another cancer.I am not currently undergoing any chemotherapy or using devices like Optune for my condition.I have only used temozolomide during radiation for my brain cancer.I have been cancer-free for a year, except for treated early-stage cancers in the last 5 years.I cannot swallow pills or capsules.I am not taking Coumadin or phenytoin medications.I am not pregnant or breastfeeding.I understand the study and can agree to participate.I have been diagnosed with a type of brain tumor called Glioblastoma.My bone marrow, liver, and kidneys are working well.I've finished the initial 6-week chemo-radiation but haven't started maintenance therapy.I can swallow pills and capsules.I do not have any serious health or mental conditions that prevent me from understanding the treatment.I have kidney or liver problems.I can take oral chemotherapy without severe allergies or side effects.I am mostly independent and can care for myself.I have a blood clotting disorder.I am between 18 and 74 years old.
- Group 1: Capecitabine amd Temozolomide
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the current number of participants in this research project?
"Affirmative. The clinical trial's listing on clinicaltrials.gov attests to its ongoing recruitment efforts, which began June 13th 2017 and was most recently updated October 17th 2022. 67 individuals are needed for the single site conducting this study."
Does this trial have an age restriction, and if so what is it?
"To be eligible for inclusion in this trial, the patient must fall between 18 and 74 years of age. Conversely, there are 215 studies available to those younger than 18 while 1651 trials target patients over 65."
To what clinical conditions is Temozolomide typically administered?
"Temozolomide is typically used to combat progression of diseases, but also has been prescribed by doctors for nitrosourea treatment, advanced mycosis fungoides, and refractory cases."
Who qualifies to join this test group?
"Qualified candidates must possess a diagnosis of glioblastoma and be between 18 to 74 years old. This medical research project is looking for 67 volunteers in total."
Has Temozolomide been investigated in any prior research projects?
"At present, 531 trials pertaining to Temozolomide are in progress. Of those studies, 149 have reached Phase 3 and 16516 medical sites are participating across the globe. The majority of these research efforts are located in Adelaide, South Australia."
Are new volunteers being recruited for this research endeavor?
"Correct. Clinicaltrials.gov reveals that this study, which was first announced on June 13th 2017, is currently enrolling participants into its trial. A total of 67 people will be recruited from one medical centre."
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