Oxidative Phosphorylation Targeting In Malignant glioma Using Metformin plus radiotherapy temozolomide

Conditions

Glioblastoma grade 4

Brief summary

Progression Free Survival estimated by the RANO criteria

Detailed description

✓ Overall survival., ✓ Overall response rate (ORR) estimated by the RANO criteria., ✓ Safety: type, frequency, and severity (grade III and IV toxicity) of AEs and SAEs., ✓ Dose interruptions, reductions, and dose intensity., ✓ Time of occurrence and evaluations of laboratory values., ✓ Several safety aspects will be recorded such as haematological toxicity (and related risks of infection and bleeding), hypersensitivity requiring treatment interruption, digestive effects (nausea, vomiting, constipation)

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGTemodal 20 mg hard capsules

DRUGMETFORMINE ARROW LAB 500 mg

DRUGcomprimé pelliculé

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression Free Survival estimated by the RANO criteria	—

Secondary

Measure	Time frame
✓ Overall survival., ✓ Overall response rate (ORR) estimated by the RANO criteria., ✓ Safety: type, frequency, and severity (grade III and IV toxicity) of AEs and SAEs., ✓ Dose interruptions, reductions, and dose intensity., ✓ Time of occurrence and evaluations of laboratory values., ✓ Several safety aspects will be recorded such as haematological toxicity (and related risks of infection and bleeding), hypersensitivity requiring treatment interruption, digestive effects (nausea, vomiting, constipation)	—

Measure

Time frame

✓ Overall survival., ✓ Overall response rate (ORR) estimated by the RANO criteria., ✓ Safety: type, frequency, and severity (grade III and IV toxicity) of AEs and SAEs., ✓ Dose interruptions, reductions, and dose intensity., ✓ Time of occurrence and evaluations of laboratory values., ✓ Several safety aspects will be recorded such as haematological toxicity (and related risks of infection and bleeding), hypersensitivity requiring treatment interruption, digestive effects (nausea, vomiting, constipation)

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Countries

France

Outcome results

None listed