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Closed (no longer recruiting)Last updated: 19 February 2024

EX-TEM: This phase III trial is trying to determine if extended post-radiation chemotherapy will improve survival outcomes in patients with newly diagnosed glioblastomaPhase III Trial of Extended Temozolomide in Newly Diagnosed Glioblastoma

Clinical summary


This trial is comparing two standards of care - 6 versus 12 cycles of post radiation temozolomide. Patients in Arm A of the trial will undergo observation with standard clinical and radiological follow up. Patients in Arm B will receive an additional 6 cycles of post-radiation temozolomide (orally) followed by observation with standard clinical and radiological follow up.


This trial is treating patients with glioblastoma.


Brain and Spinal Cancers Brain and Spinal





Trial Acronym


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Trial Identifiers

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Trial sponsor

Walter and Eliza Hall Institute

Scientific Title

Phase III Trial of Extended Temozolomide in Newly Diagnosed Glioblastoma



1. Males or females with newly diagnosed, histologically confirmed glioblastoma
2. Adults, aged 18 years and over
3. Completed radiation plus concurrent temozolomide, followed by six cycles of post-radiation temozolomide
4. No evidence of progressive disease on on-study screening MRI. Residual disease or enhancement is allowed, as long as stability or response according to RANO criteria has been demonstrated compared with prior MRI
5. ECOG 0-2
6. Life expectancy of > 12 weeks
7. Fit for further temozolomide
8. Able to start study treatment within four weeks of day one of cycle six
9. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
10. Signed, written informed consent.


1. Progressive disease on on-study screening MRI according to RANO criteria when compared with prior MRI
2. Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may interact with the administration of study treatments or procedures
3. Other comorbidities or conditions that may compromise assessment of key outcomes
4. No temozolomide or cranial irradiation in the last five years prior to GBM diagnosis.
5. History of another malignancy within five years prior to registration. Patients with curatively treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or superficial transitional cell carcinoma of the bladder are eligible.
6. Significant infection, including chronic active hepatitis B, hepatitis C or HIV.
7. Concurrent illness,
8. Pregnancy, lactation, or inadequate contraception.


  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has not spread to other parts of the body.


  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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