Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM (NCT03213002) | Clinical Trial Compass
RecruitingPhase 1/2
Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM
United States67 participantsStarted 2017-06-13
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide when you start your monthly regimen of oral temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM).
Capecitabine is an oral chemotherapy that is given to patients with other types of cancer. The study will evaluate whether the dosage of 1500 mg/m2 of capecitabine is tolerable after radiation, when taken along with temozolomide. It will also try to determine if the medication capecitabine helps patients respond to treatment for a longer period of time compared to just temozolomide alone, which is the standard of care.
Who can participate
Age range
18 Years – 74 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Be capable of giving informed consent.
. Have a pathology proven diagnosis of any of newly diagnosed Glioblastoma Multiforme WHO IV
. Have completed the first part of standard of care chemo-radiation (Stupp), for 6 weeks, and not started the maintenance phase of temozolomide
. Agree to use effective barrier contraception while on treatment and for 2 months thereafter, if of childbearing potential
. Have a life expectancy \> 3 months
. Be between the ages of 18 to 74
. Have a performance status KPS 70 or greater
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Prior chemotherapy with capecitabine or temozolomide for other prior malignancies. Patients previously treated with continuous infusion 5-FU or any schedule of DTIC, which are similar to capecitabine and temozolomide, respectively, will be excluded.
. Prior chemotherapies for newly diagnosed GBM or AA, other than temozolomide during radiation.
. Patients with a history of severe hypersensitivity reaction to capecitabine, 5-FU, temozolomide (i.e. anaphylaxis or anaphylactic reactions),
. Serious medical or psychiatric illness preventing informed consent or treatment (e.g., serious infection)
. Prior malignancies in the last 5 years other than curatively treated carcinoma in-situ previously treated with curative intent (cancer free for the past one year).
. Performance status, KPS \< 70
. Inability to swallow pills and capsules
. Concurrent chemotherapy or treatment for the active disease, including devices such as Optune, high dose vitamin supplements, or any other chemotherapy