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Evaluation of the Irinotecan/Bevacizumab Association as Neo-adjuvant and Adjuvant Treatment of Chemoradiation With Temozolomide for Naive Unresectable Glioblastoma. Phase II Randomized Study With Comparison to Chemoradiation With Temozolomide


Phase 2
18 Years
70 Years
Not Enrolling
Both
Naive Unresectable Glioblastoma

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Trial Information

Evaluation of the Irinotecan/Bevacizumab Association as Neo-adjuvant and Adjuvant Treatment of Chemoradiation With Temozolomide for Naive Unresectable Glioblastoma. Phase II Randomized Study With Comparison to Chemoradiation With Temozolomide


Inclusion Criteria:



All the eligibility criteria must be met before registration :

- delay upper or equal to 14 days from stereotaxic biopsy and 28 days from surgical
biopsy

- Histopathologically proven diagnosis of glioblastoma (WHO grade IV astrocytoma)

- Patient belonging to the RPA V class or associated

- only supratentorial glioblastoma

- Diagnosis must be obtained by a stereotactic or surgical biopsy

- Age between 18 and 70

- A contrast-enhanced MRI must be performed within 28 days prior to study registration

- Total or partial surgical resection deemed as not possible by a neurosurgeon

- Karnofsky Index (KI) performance status over 50

- Life expectancy of at least 3 months

- A stable dose of corticosteroid for at least 7 days to control intracranial pressure
and neurological symptoms

- Adequate blood function : absolute neutrophil count > 1.5 x 109/L, platelets count >
100 x 109/L platelets; hemoglobin > 10 g/dl after blood transfusion if required

- Adequate liver function: bilirubin < 1.5 ULN (upper limit of normal), ALT and AST <
2.5 ULN, Prothrombin rate > 75 %

- Adequate renal function: creatinine < 1.2 ULN; proteinuria test 0 or trace (or urine
protein concentration < 1g/24h if proteinuria test is + or ++).

- Negative pregnancy test for women of childbearing potential and adequate
contraception for men and women.

- systolic arterial blood pressure at rest ≤ 170 mmHg

- Patient must have been informed and must have signed the specific informed consent
form.

- holder of a coverage by the health insurance

Exclusion Criteria:

- patient belonging to the RPA III or IV

- prior malignant tumor in the recent 5 years or concomitant malignancy

- prior anti-tumoral chemotherapy or radiotherapy

- prior gross resection of the brain tumor

- patient receiving gliadel

- cardiovascular contra-indications to bevacizumab : prior angina pectoris, prior
myocardial infarction, prior brain stroke, even transient, distal severe
arteriopathy, uncontrolled high blood pressure

- anticomitial drug p450 cytochrome inductors

- other substances inducing p450 cytochrome

- proteinuria ≥ 1g/L

- concurrent anticoagulant or platelet anti-aggregant treatment

- congenital haemorrhagic pathology (haemophilia, Willebrandt)

- sign of brain haemorrhage on the RMI initial exam

- non resolved infectious disease

- non controlled arterial hypertension (≥170 mmHg)

- intracranial high pressure not controlled by a stable dose of steroids for at least 7
days

- pregnancy or refusal of the contraception for women and men

- psychiatric, behavioural disorders or geographical situation precluding the
administration or follow-up of the protocol (including claustrophobia)

- digestive haemorrhage and / or gastro-duodenal ulcer occurring in the last 3 months

- pregnant, nursing woman, or without contraception

- private individuals of freedom or under tutelage (including legal guardianship)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the rate of non-progressive disease at 6 months after inclusion in each arms

Outcome Time Frame:

after half of each arms has been completed at 6 months of treatment

Safety Issue:

Yes

Principal Investigator

Bruno Chauffert, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU d'Amiens

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

TemAvIr

NCT ID:

NCT01022918

Start Date:

January 2009

Completion Date:

January 2011

Related Keywords:

  • Naive Unresectable Glioblastoma
  • unresectable glioblastoma
  • Glioblastoma

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