A Study of Whole Brain Radiation Therapy and Capecitabine in Breast Cancer Participants With Newly Diagnosed Brain Metastasis (XERAD)
26. září 2016 aktualizováno: Hoffmann-La Roche
XERAD: Open-Label, Phase II, Randomized, Comparative, Multicentre Trial of Concurrent Whole Brain Radiation Therapy (WBRT) and Capecitabine (Xeloda®) Followed by Maintenance Capecitabine Compared With Standard WBRT in Breast Cancer Patients With Newly Diagnosed Brain Metastasis
This open-label, randomized, parallel arm study will evaluate the effect of capecitabine administered concurrently with WBRT and as maintenance therapy in participants with breast cancer and newly diagnosed brain metastases.
Participants will be randomized to receive either capecitabine with 10 days standard WBRT, or WBRT alone.
Maintenance therapy will follow with capecitabine or another systemic therapy in the WBRT only group.
Přehled studie
Postavení
Ukončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
24
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Arras, Francie, 62000
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Beuvry, Francie, 62660
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Beziers, Francie, 34500
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Bobigny, Francie, 93009
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Dijon, Francie, 21079
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Le Mans, Francie, 72015
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Lille, Francie, 59020
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Lyon, Francie, 69373
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Montpellier, Francie, 34928
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Nantes, Francie, 44202
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Narbonne, Francie, 11780
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Nice, Francie, 06000
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Paris, Francie, 75651
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Paris, Francie, 75475
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Rouen, Francie, 76000
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Salouel, Francie, 80480
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
Inclusion Criteria:
- Women with histologically confirmed breast cancer with known human epidermal receptor-2 (HER2) and hormone status
- Newly diagnosed CNS metastasis with at least one brain lesion measuring greater than or equal to (>/=) 1 centimeter (cm) or two lesions measuring >/= 0.5 to less than (<) 1 cm in longest dimension
- Participant not eligible for or refusing surgery or stereotactic radiosurgery
- Eastern cooperative oncology group (EOCG) performance status 0 to 2
Exclusion Criteria:
- Prior treatment of brain metastases
- Leptomeningeal disease
- Known contra-indication to radiotherapy or magnetic resonance imaging (MRI) or capecitabine
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: WBRT Followed by Standard of Care
Participants will receive 3000 centi-Gray (cGy) WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT.
The participants will be followed during the treatment until the halting of standard of care for any reason (central nervous system [CNS] or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
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3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction).
The choice of standard of care will be at the discretion of the treating oncologist.
The protocol does not specify any particular standard of care treatment.
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Experimentální: WBRT+Capecitabine Followed by Capecitabine Maintenance
Participants will receive 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 milligrams per square meter (mg/m^2) orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
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3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction).
825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Percentage of Participants With Best Objective Central Nervous System (CNS) Response, Assessed by Centralized Independent Expert According to Magnetic Resonance Imaging (MRI) - Intent-to-Treat (ITT) Population
Časové okno: Baseline until disease progression (PD), unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
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Best objective CNS response was defined as having complete response (CR) or partial response (PR) for CNS metastasis, assessed by contrast-enhanced MRI using response evaluation criteria in solid tumors (RECIST).
CR: disappearance of all CNS lesions.
PR: greater than or equal to (>/=) 30 percent (%) decrease in sum of longest diameters (LD) of CNS lesions taking as reference the baseline sum LD.
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Baseline until disease progression (PD), unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
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Percentage of Participants With Best Objective CNS Response, Assessed by Centralized Independent Expert According to MRI - Per-Protocol (PP) Population
Časové okno: Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
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Best objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST.
CR: disappearance of all CNS lesions.
PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.
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Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Centralized Independent Expert According to MRI
Časové okno: Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)
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Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST.
CR: disappearance of all CNS lesions.
PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.
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Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)
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Percentage of Participants With Best Objective CNS Response, Assessed by Investigator According to MRI
Časové okno: Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
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Best objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST.
CR: disappearance of all CNS lesions.
PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.
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Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
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Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Centralized Independent Expert According to MRI in 3 Dimension
Časové okno: Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)
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Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by 3 dimensional MRI using RECIST.
CR: disappearance of all CNS lesions.
PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.
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Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)
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Percentage of Participants With Clinical Benefit, Assessed by Investigator According to MRI
Časové okno: Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
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Clinical benefit was defined as having CR, PR, or stable disease (SD), assessed by contrast-enhanced MRI using RECIST.
CR: disappearance of all CNS lesions.
PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.
SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference smallest sum LD since treatment started.
PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions.
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Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
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Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Investigator According to MRI
Časové okno: Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)
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Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST.
CR: disappearance of all CNS lesions.
PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.
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Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)
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Duration of CNS Response, Assessed by Investigator According to MRI
Časové okno: Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
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Duration of CNS response was defined as the time from first documented cranial CR or PR (whichever was recorded first) until the first date CNS recurrence or progression was documented as assessed by contrast-enhanced MRI according to RECIST criteria but without exam for response confirmation.
CR: disappearance of all CNS lesions.
PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.
PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions.
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Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
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Time to CNS Progression, Assessed by Investigator According to MRI
Časové okno: Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
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Time to CNS progression was defined as the time from start of study treatment to first documentation of PD or death due to CNS metastasis.
PD was assessed by contrast-enhanced MRI according to RECIST.
PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions.
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Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
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Percentage of Participants With Best Objective Extra-cranial Disease Response, Assessed by Investigator According to Computed Tomography (CT)
Časové okno: Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
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Best objective extra-cranial response was defined as having CR or PR for extra-cranial lesions, assessed by CT using RECIST.
CR: disappearance of all extra-cranial lesions.
PR: >/=30 % decrease in sum of LD of extra-cranial lesions taking as reference the baseline sum LD.
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Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
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Percentage of Participants With Objective Extra-cranial Disease Response at 4 Weeks After Completion of WBRT, Assessed by Investigator According to CT
Časové okno: Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)
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Objective extra-cranial response was defined as having CR or PR for extra-cranial lesions, assessed by CT using RECIST.
CR: disappearance of all extra-cranial lesions.
PR: >/=30 % decrease in sum of LD of extra-cranial lesions taking as reference the baseline sum LD.
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Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)
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Time to Extra-cranial Disease Progression, Assessed by Investigator According to CT
Časové okno: Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
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Time to extra-cranial progression was defined as the time from start of study treatment to first documentation of PD or death due to extra-cranial lesions.
PD was assessed by CT according to RECIST.
PD: a 20% or greater increase in the sum of the LD of extra-cranial lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more extra-cranial lesions and/or unequivocal progression of existing extra-cranial lesions.
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Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
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Time to Progression, Assessed by Investigator According to MRI and CT
Časové okno: Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
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Time to progression was defined as the time from start of study treatment to first documentation of PD or death due to tumor (CNS or extra-cranial).
PD was assessed by MRI or CT according to RECIST.
PD: a 20% or greater increase in the sum of the LD of CNS or extra-cranial lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS or extra-cranial lesions and/or unequivocal progression of existing CNS or extra-cranial lesions.
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Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm "WBRT Followed by Standard of Care" only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
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Overall Survival (OS)
Časové okno: Baseline until death (up to approximately 1 year 5.5 months overall)
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OS was defined as the time from the start of study treatment to date of death due to any cause.
OS was assessed using Kaplan-Meier analysis.
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Baseline until death (up to approximately 1 year 5.5 months overall)
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Absolute Change From Baseline in Mini Mental State (MMS) Total Score
Časové okno: Baseline, Up to end of Treatment (up to 10.6 months overall)
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MMS was an 11-question measure that tested five areas of cognitive function: orientation, registration, attention and calculation, recall, and language.
Four items were scored on a scale of 0 to 1; 1 item was scored on a scale of 0 to 2; 3 items were scored on a scale of 0 to 3; and 3 items were scored on a scale of 0 to 5. MMS total score was obtained by adding the scores of all individual items and ranged from 0 to 30, where higher scores indicate better cognitive state.
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Baseline, Up to end of Treatment (up to 10.6 months overall)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. srpna 2009
Primární dokončení (Aktuální)
1. února 2011
Dokončení studie (Aktuální)
1. února 2011
Termíny zápisu do studia
První předloženo
14. září 2009
První předloženo, které splnilo kritéria kontroly kvality
14. září 2009
První zveřejněno (Odhad)
15. září 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
15. listopadu 2016
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
26. září 2016
Naposledy ověřeno
1. září 2016
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Kožní choroby
- Novotvary
- Novotvary podle místa
- Nemoci prsu
- Novotvary centrálního nervového systému
- Novotvary nervového systému
- Novotvary prsu
- Novotvary mozku
- Molekulární mechanismy farmakologického působení
- Antimetabolity, Antineoplastika
- Antimetabolity
- Antineoplastická činidla
- Kapecitabin
Další identifikační čísla studie
- ML21873
- 2008-007349-30
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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