Treatment Intensification With Temozolomide in Adults With a Glioblastoma

Launched by CENTRE OSCAR LAMBRET · Sep 6, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat adults with glioblastoma, a type of brain cancer. Researchers want to find out if starting chemotherapy with a drug called Temozolomide (TMZ) earlier, and continuing it for a longer time, could be more effective than the usual treatment plan. The trial compares this new approach to the standard treatment, which typically begins about a month after surgery and limits the number of chemotherapy cycles.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of newly diagnosed glioblastoma. They should be in reasonably good health, meaning they can perform daily activities and have good organ function. Participants will receive either the new treatment or the standard one and will be closely monitored throughout the study. It’s important to note that women who can become pregnant must take a pregnancy test and agree to use contraception during the study. If you or a loved one are considering participation, it's a good opportunity to contribute to research that may improve future treatments for glioblastoma.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient ≥18 years old
• • Histological diagnosis of de novo GBM (extemporaneous diagnosis or standard pathological examination). In case of extemporaneous diagnosis, the patient can be included. If the diagnosis is not confirmed, the patient will be withdrawn from study.
• • Time between initial surgery/biopsy and planned start of treatment (if allocated to the experimental arm) ≤ 15 days (ideally in the first 7 days)
• • Karnofsky performance status (KPS) ≥ 60%, or KPS \<60% only related to glioma-related motor paresis.
• • Adequate biological functions
• • Common toxicity criteria (CTC) non hematological adverse events ≤ Grade 1 (except for alopecia, nausea, vomiting and neurological symptoms)
• • Females of child bearing potential must have a negative serum or urine pregnancy test within 7 days prior to initiation of treatment. Sexually active patients must agree to use adequate and appropriate contraception while on study drug and for 6 months after stopping the study drug.
• • Standard radiation therapy deemed feasible (60 Gy, 30 fractions)
• • Time interval of less than 43 days between initial surgery/biopsy and planned start of radiation therapy
• • Written informed consent
• Exclusion Criteria:
• • Secondary or recurrent glioblastoma (GBM)
• • Planned use of tumor-treating electric fields
• • Planned use of Carmustine implants
• • Prior malignancy in the last 5 years before inclusion or concomitant
• • Severe myelosuppression
• • Known hypersensitivity to any of the study drugs, study drug classes, excipients in the formulation or to dacarbazine (DTIC)
• • Current or recent treatment with another experimental drug or patients included in a clinical therapeutic trial (in the 30 days prior to inclusion).
• • Known current viral hepatitis, HIV infection or current active infectious disease
• • Inability to swallow oral medications or any mal-absorption condition
• • Pregnant or breastfeeding patients.
• • Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
• • Person under guardianship or curatorship