- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03623347
Upfront Bevacizumab/témozolomide for Gliomastomas With Neurological Impairment (TEMOBEVA)
Neo-adjuvant Treatment of Glioblastomas With Marked to Severe Neurological Impairment Using Upfront Bevacizumab/témozolomide Association Before an Eventual Radiotherapy. Multicentric Phase II Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
New approaches are needed for patients newly diagnosed with bulky glioblastoma (GB) and/or with severe neurological impairment that cannot benefit from first line temozolomide (TMZ)-based chemoradiotherapy. Bevacizumab (BEV), an antiangiogenic anti-VEGF-R monoclonal antibody, has a rapid impact on tumor-related brain edema in recurrent GB. The present study reports the feasibility and efficacy of an induction treatment with TMZ and BEV to alleviate the initial neurological impairment and/or to reduce the tumor volume before a delayed chemoradiotherapy.
The investigators retrospectively analyzed tumor and target volumes and clinical neurological status in 39 patients with bulky GB and/or with severe neurological impairment after an induction treatment combining TMZ and BEV. Neurological and radiological responses were assessed according to RANO criteria.
Calculating gross tumor and clinical target volumes (GTV and CTV) was done at diagnosis and before radiotherapy. Progression-free survival (PFS) and overall survival (OS) were determined by Kaplan Meier methods. Safety was reported according to NCTCAE.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Clinical criteria:- - age> to 18 years
- GBM de novo
- Histological evidence is essential. A minimum interval of 7 days is required between biopsy and neo-adjuvant therapy. A minimum interval of 15 days is required for open skull surgery and neo-adjuvant therapy.
- The insertion of patients is a WHO score 3 and 4 in relation to the neurological deficit is possible by definition
Biological criteria
- Polynuclear neutrophils> 1500 / mm3
- pads> 100,000 / mm3
- SGOT <5 at the upper limit of normal (ULN)
- bilirubin <1.5 x ULN
- Creatinine <1.5 ULN
- proteinuria <2 g / 24 hours
Forensic criteria
- Patient with health insurance
- consent signed by the patient if it is lucid, or by default by the person of trust.
Exclusion Criteria:
1. Patients without neurological deficit (SN 0) or with moderate deficit (SN 1 or SN 2).
2. In case of initial neurological deficit SN 3-4, the interest of a decompression surgery must be discussed. If the surgery is unsuccessful, a corticosteroid test, at least 4 days, with at least 1.5 mg / kg / day of prednisone equivalent, must be performed. If surgery and / or corticosteroids allow to return to an SN 0-2 neurological score with return to an RPA III, IV or V class, the patient is not included and must be treated according to a conventional chemoradiotherapy regimen with temozolomide (Stupp schema).
3. Multifocal tumor or whose excessive volume does not allow to consider curative radiation therapy at a dose of 60 Gy.
3. History of chemotherapy, (including Gliadel) and / or radiotherapy. 4. Cerebral or intratumoral haemorrhage on diagnostic MRI. However, microhemorrhages, haemosiderin deposits or haemorrhages secondary to biopsy or surgery are not contraindications.
5. Concomitant serious uncontrolled pathology, including another evolving cancer 6. Uncontrolled infection 7. Uncontrolled Hypertension (PAS> 160 mm Hg) Despite Optimized Treatment 8. Coronary artery disease or unstable arterial disease. Evolutionary aneurysm. Myocardial infarction less than 6 months old.
9. Stroke or peripheral arterial disease less than 6 months old. 10. Heart Failure> NYHA Grade II 11. Haemorrhagiparous disease (hemophilia, Willebrandt ...) 12. History of hemoptysis less than 1 month old. 13. Pulmonary embolism less than 1 month old. 14. Anticoagulant or antiplatelet therapy in progress. If possible, these treatments should be stopped before inclusion after consultation with a cardiologist or angiologist. However, these treatments may be continued if their discontinuation is considered harmful and that the participation in the trial is considered beneficial for the patient with regard to the haemorrhagic risk incurred.
15. Surgical procedure (other than craniotomy or stereotactic biopsy) less than one month old or foreseeable surgery.
16. History of digestive fistula or intestinal perforation whose resolution is less than 6 months old.
17. Pregnant or lactating patient (contraception to be prescribed if necessary) 18. Known intolerance to bevacizumab or temozolomide
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optimal chemoradiotherapy after upfront TMZ and BEV treatment.
Time Frame: 4-months
|
The investigators reported here a series of patients in whom radiotherapy was considered as not feasible in first intention but most of which could be treated by optimal chemoradiotherapy after upfront TMZ and BEV treatment.
The investigators analyzed the impact of this induction strategy on tumor and target volumes, neurological status and survival.
|
4-months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mathieu Boone, MD, CHU Amiens
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2011_843_0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chemoradiotherapy
-
Texas A&M UniversityUnknownCancer Patients Receiving Chemotherapy or ChemoradiotherapyUnited States
-
Xiaoqin LuoRecruitingCancer | Clinical Outcomes | Oncology | Nutrition, Healthy | ChemoradiotherapyChina
-
Peking UniversityNot yet recruitingGastroesophageal Junction Cancer | Chemoradiotherapy | PD-1
-
Fondazione Policlinico Universitario Agostino Gemelli...Viewray Inc.UnknownLocally Advanced Rectal Cancer | Pathological Complete Response | Neoadjuvant ChemoradiotherapyItaly
-
Fudan UniversityUnknownNSCLC | Chemoradiotherapy | ctDNAChina
-
Cancer Institute and Hospital, Chinese Academy...CompletedRectal Cancer | Surgery | Adjuvant Chemotherapy | Neoadjuvant Chemoradiotherapy | Adjuvant ChemoradiotherapyChina
-
Shanghai Jiao Tong University School of MedicineRuijin HospitalUnknownChemoradiotherapyChina
-
Zhongnan HospitalRecruitingConcurrent Chemoradiotherapy;Nutrition;Multimodal RehabilitationChina
-
Erasmus Medical CenterActive, not recruitingEsophageal Cancer | Surgical Oncology | Neoadjuvant Chemoradiotherapy | Active SurveillanceNetherlands
-
Abramson Cancer Center at Penn MedicineRecruitingLocally Advanced Unresectable Pancreatic Cancer Treated With Chemoradiotherapy | Borderline Resectable Pancreatic Cancer Treated With ChemoradiotherapyUnited States
Clinical Trials on TMZ and BEV induction before chemoradiotherapy
-
Barretos Cancer HospitalRecruitingLocally Advanced Malignant NeoplasmBrazil
-
Peking Union Medical College HospitalNot yet recruitingHypopharyngeal Squamous Cell Carcinoma
-
Sun Yat-sen UniversityActive, not recruitingAdvanced Rectal CancerChina
-
Nanfang Hospital of Southern Medical UniversityRecruitingCisplatin | NPC | CarboplatinChina
-
Barretos Cancer HospitalCompleted
-
Fifth Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
-
Lund University HospitalCompletedAcute Myeloid Leukemia | Acute Lymphoblastic LeukemiaSweden
-
Radiation Therapy Oncology GroupNational Cancer Institute (NCI)CompletedBladder CancerUnited States, Canada
-
Seoul National University HospitalNot yet recruitingPharyngeal Diseases | Thoracic Surgery, Video-Assisted | Chewing Gum
-
Boston UniversityCompletedAbortion, Induced | Abortion, Second TrimesterUnited States