Treatment Intensification With Temozolomide in Adults With a Glioblastoma (StrateGlio)

• ClinicalTrials.gov Identifier: NCT03663725
• Recruitment Status: Recruiting
• First Posted: September 10, 2018
• Last Update Posted: May 15, 2019
• Sponsor: Centre Oscar Lambret
• Collaborators: Association de Neuro-Oncologues d'Expression Francaise; Erasme University Hospital
• Information provided by (Responsible Party): Centre Oscar Lambret

Tracking Information

• First Submitted Date: September 4, 2018
• First Posted Date: September 10, 2018
• Last Update Posted Date: May 15, 2019
• Actual Study Start Date: March 13, 2019
• Estimated Primary Completion Date: May 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 6, 2018)

Overall Survival (OS) [ Time Frame: up to 18 months after recruitment of the last patient ]

time interval from randomization to death whatever the cause

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 6, 2018)

• Number of adverse events [ Time Frame: up to 18 months after recruitment of the last patient ]
  from randomization until disease progression - reported and graded using the NCI-CTCAE v5.0 classification
• Progression-free survival [ Time Frame: up to 18 months after recruitment of the last patient ]
  time interval from randomization to the first occurrence of progression according to RANO criteria as assessed by the treating physician, or death whatever the cause

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment Intensification With Temozolomide in Adults With a Glioblastoma
• Official Title: Phase III Randomised Trial Evaluating Treatment Intensification With Temozolomide in Adults With a Glioblastoma
• Brief Summary: Due to conflicting data on the optimal moment to start TMZ chemotherapy and the impact of prolongation of the adjuvant phase with TMZ, the ANOCEF (Association des Neuro-Oncologues d'Expression Francophone) group proposes this randomized trial comparing an intensified arm (early TMZ and extended adjuvant TMZ until toxicity, progression or patient refusal) versus the classical EORTC regimen as control (RT and concomitant TMZ started 4-6 weeks after surgery followed by a number of adjuvant TMZ cycles strictly limited to 6) for primary GBM adult patients.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Glioblastoma

Intervention

• Drug: Intensified protocol
  Early Temozolomide (TMZ) 1 cycle (150 mg/m²/ day X 5 days, per os) Started between day 2 and 15 after surgery/ biopsy RT (60 Gy, 2 Gy/fraction) + concomitant TMZ (75 mg/m2/day X 42 days, per os) Started between W4 and W6 after surgery/ biopsy Adjuvant TMZ 6 cycles (150-200 mg/m2 X 5 days /month, per os) Started 1 month after the end of the concomitant TMZ Prolonged TMZ Until progression, intolerance, patient's or physician's decision (150-200 mg/m2 every 4 weeks, per os)
• Drug: Stupp protocol
  RT (60 Gy, 2 Gy/fraction) + concomitant Temozolomide (75 mg/m2/day X 42 days, per os) Started between W4 and W6 after surgery/ biopsy Adjuvant TMZ 6 cycles (150-200 mg/m2 X 5 days /month, per os) Started 1 month after the end of the concomitant TMZ

Study Arms

• Experimental: Intensified protocol
  Early Temozolomide (TMZ) Concomitant TMZ Adjuvant TMZ Prolonged TMZ
  Intervention: Drug: Intensified protocol
• Active Comparator: Stupp protocol
  Concomitant Temozolomide (TMZ) Adjuvant TMZ
  Intervention: Drug: Stupp protocol

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 6, 2018): 535
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 1, 2023
• Estimated Primary Completion Date: May 1, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Marie VANSEYMORTIER; 33320295918; promotion@o-lambret.fr

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03663725
• Other Study ID Numbers: StrateGlio-1802; 2018-000410-38 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Centre Oscar Lambret
• Study Sponsor: Centre Oscar Lambret

Collaborators

• Association de Neuro-Oncologues d'Expression Francaise
• Erasme University Hospital

Investigators

• Principal Investigator: Florence LEFRANC, MD; ERASME
• Principal Investigator: Bruno CHAUFFERT, MD; CHU Amiens

• PRS Account: Centre Oscar Lambret
• Verification Date: May 2019