- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01015534
Whole Brain Radiotherapy With or Without Temozolomide at Daily Fixed-dose for Brain Metastases Treatment
Phase II Randomized Study: Whole Brain Radiotherapy and Concomitant Temozolomide, Compared With Whole Brain Radiotherapy for Brain Metastases Treatment
RATIONALE
- Fractionated radiotherapy uses high-energy photons to kill, or damage tumor cells. High daily dose temozolomide combined with fractionated radiotherapy may make tumor cells more sensible to treatment.
PURPOSE
- This randomized phase II trial, assess in patients with brain metastases from solid tumors, whether the whole brain radiotherapy (WBRT) plus temozolomide is able to improve the results obtained with WBRT.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Primary Outcome Measures
- Objective Response Rates
Secondary Outcome Measures
- Survival Free of Brain Metastases progression
- Overall Survival
- Systemic Side effects
Objectives
Primary
- Compare objective response rates in both arms of treatment
Secondary
- Compare survival free of progression in both arms of treatment
- Compare Overall Survival in both arms of treatment
- Compare side effects
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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D.F
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México, D.F, Mexico, 14080
- Instituto Nacional De Cancerologia de Mexico
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Karnofsky performance status (KPS) ≥ 50
- Life expectancy ≥ 12 weeks
- Histologically confirmed non lymphomatous solid tumors at primary site
- Brain metastases diagnosed with cranial MRI/CT.
- Extracranial metastases or primary tumor uncontrolled are allowed
- Hemoglobin ≥ 10 g/dl
- Absolute neutrophil count of > 1500/mm3
- Platelet count of ≥ 100,000/mm3
- Blood urea nitrogen (BUN) ≤ 25 mg/dl,
- Serum creatinin ≤ 1.5 mg/dl
- Serum bilirubins ≤ 1.5 mg/dl,
- Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ twice the upper normal limit
Exclusion Criteria
- Pregnant or breast feeding woman
- History of allergic reaction to iodinated contrast media
- Inability to swallow
- Systemic chemotherapy in previous 3 weeks
- Oral chemotherapy in previous 2 weeks
- Prior surgery, chemotherapy, or radiotherapy for a brain neoplasm
- Meningeal carcinomatosis
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Whole brain irradiation plus Temozolomide
Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday.
Without adjuvant cycles of Temozolomide.
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Andre navne:
Andre navne:
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Aktiv komparator: Whole brain irradiation
Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks
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Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Objective Response Rates. Assessed With Cranial MRI
Tidsramme: 90 days
|
Objective Response (OR) encompassed the number of participants with Complete Response (CR) and the number of participants with Partial Response (PR). CR is the disappearance of all brain metastases, assessed between two or more cranial MRI. PR is at least a 30% decrease in the sum of the longest diameter of the brain metastases, taking as reference the baseline sum longest diameter, assessed between two or more cranial MRI. Objective Response Rate (ORR) is the ratio between the number of participants with objective response and the total number of participants. |
90 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Survival Free of Brain Metastases Progression (PFS of BM)
Tidsramme: at 90 days
|
Progression free survival of brain metastases is the survival of participants without progressive brain metastases or without neurological symptoms.
The progressive brain metastases (PBM) were evaluated with cranial MRI.
The PBM were defined as an increase of at least 20% in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new metastases.
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at 90 days
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Overall Survival
Tidsramme: 1 year
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Overall survival:Time in months measured from treatment initiation until the date of death or the date of last follow-up.
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1 year
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Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.
Tidsramme: 4 months
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AE, evaluated and graded according to the NCI common terminology criteria (NCI-CTCAE) v3.0 Grade 3 Severe AE. Grade 4 Life-threatening or disabling AE. |
4 months
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Carlos Gamboa-Vignolle, MD, Instituto Nacional De Cancerologia de Mexico
Publikationer og nyttige links
Generelle publikationer
- Jones SF, Greco FA, Gian VG, Miranda FT, Raefsky EL, Hainsworth JD, Willcutt NT, Beschorner AF, Kennerly G, Burris HA 3rd. A Phase I trial of protracted oral fixed-dose temozolomide. Cancer. 2005 Nov 1;104(9):1985-91. doi: 10.1002/cncr.21408.
- Antonadou D, Paraskevaidis M, Sarris G, Coliarakis N, Economou I, Karageorgis P, Throuvalas N. Phase II randomized trial of temozolomide and concurrent radiotherapy in patients with brain metastases. J Clin Oncol. 2002 Sep 1;20(17):3644-50. doi: 10.1200/JCO.2002.04.140.
- Verger E, Gil M, Yaya R, Vinolas N, Villa S, Pujol T, Quinto L, Graus F. Temozolomide and concomitant whole brain radiotherapy in patients with brain metastases: a phase II randomized trial. Int J Radiat Oncol Biol Phys. 2005 Jan 1;61(1):185-91. doi: 10.1016/j.ijrobp.2004.04.061.
- Gamboa-Vignolle C, Ferrari-Carballo T, Arrieta O, Mohar A. Whole-brain irradiation with concomitant daily fixed-dose temozolomide for brain metastases treatment: a randomised phase II trial. Radiother Oncol. 2012 Feb;102(2):187-91. doi: 10.1016/j.radonc.2011.12.004. Epub 2012 Jan 16.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Neoplasmer
- Neoplasmer efter sted
- Neoplastiske processer
- Neoplasmer i centralnervesystemet
- Neoplasmer i nervesystemet
- Neoplasma Metastase
- Neoplasmer i hjernen
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Temozolomid
Andre undersøgelses-id-numre
- 006/004/TEI
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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