A randomized multicentric phase II study of prolonged adjuvant Temozolomide or "stop and go" in glioblastoma patients : the PATSGO study. - the PATSGO study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004635-30-BE

Enrollment

Registered

2007-10-26

Start date

2008-11-20

Completion date

Unknown

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

It is an open-label, randomised multicentric phase II study of prolonged adjuvant Temozolomide versus "stop and go" in glioblastoma patients. This study will include a total of 70 patients. The study will determine the time to progression under TMZ, overall survival,progression-free survival (PFS),quality of life of patients. It will also determine the toxicity,response rate of Temozolomide in rechallenge arm and if the MGMT gene status can predict a benefit of TMZ in terms of PFS.

Interventions

Trade Name: Temodal Product Name: TEMOZOLOMIDE Pharmaceutical Form: Capsule*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with histologically confirmed diagnosis of GBM. 2) Availability of pre-treatment GBM tissue to determine the activation status of MGMT gene is not mandatory but strongly recommended 3) Patients must have received radiation and TMZ for 6 weeks followed by 6 months of TMZ. Randomization should be performed within the 6 weeks after the last chemotherapy. 4) A brain MRI with or without a PET-Scan-methionine postive must be performed before enrollment. 5) Age = 18 years 6) Karnofsky Performance status =70 7) Normal haematological functions: ANC =1.5*109cells/l, platelets =100*109 cells/l 8) Normal liver function: total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: All non inclusion criteria.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether prolonged administration of Temozolomide in glioblastoma patients increase their progression-free and overall survival at 6 months. ;Secondary Objective: 1)To assess the safety and adverse event profile of prolonged adjuvant Temozolomide by using Common Terminology Criteria for Adverse Events (CTCAE 3.0). 2)To compare the Health-Related Quality of Life of the patients randomized in the two treatment arms by using the EORTC QLQ-C30 questionnaire and to study chages of QoL over time. 3)To measure the overall tumor response in patients when they are rechallenge with Temozolomide in the Stop and Go arm. 4)To measure the time to progression under Temozolomide in the Stop and Go arm. 5)To compare the time to progression under Temozolomide defined as the time between randomization and progression under Temozolomide between the two randomized treatment arms. 6)To determine if MGMT gene methylation status can predict a benefit of Temozolomide treatment in terms of Progression-Free Survival (both arms) and tumor response (only in the Stop and Go arm). ;Primary end point(s): 1)Time to progression under TMZ defined as the time between randomisation and progression under Temozolomide.	—

Measure

Time frame

Main Objective: To determine whether prolonged administration of Temozolomide in glioblastoma patients increase their progression-free and overall survival at 6 months. ;Secondary Objective: 1)To assess the safety and adverse event profile of prolonged adjuvant Temozolomide by using Common Terminology Criteria for Adverse Events (CTCAE 3.0). 2)To compare the Health-Related Quality of Life of the patients randomized in the two treatment arms by using the EORTC QLQ-C30 questionnaire and to study chages of QoL over time. 3)To measure the overall tumor response in patients when they are rechallenge with Temozolomide in the Stop and Go arm. 4)To measure the time to progression under Temozolomide in the Stop and Go arm. 5)To compare the time to progression under Temozolomide defined as the time between randomization and progression under Temozolomide between the two randomized treatment arms. 6)To determine if MGMT gene methylation status can predict a benefit of Temozolomide treatment in terms of Progression-Free Survival (both arms) and tumor response (only in the Stop and Go arm). ;Primary end point(s): 1)Time to progression under TMZ defined as the time between randomisation and progression under Temozolomide.

—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026