- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01972490
Avastin in Combination With Chemotherapy for RAS Mutant Unresectable Colorectal Liver-limited Metastases
15. december 2019 opdateret af: Xu jianmin
Study of Avastin in Combination With Chemotherapy for the First Line Treatment of RAS Mutant Unresectable Colorectal Liver-limited Metastases
In this study, the investigators assessed the effect of avastin in combination with chemotherapy in the treatment of RAS mutant-type, unresectable colorectal liver-limited metastases
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Patients will be eligible for inclusion if the patients have histologically confirmed colorectal adenocarcinoma with RAS mutant liver-confined metastases deemed non-resectable.
Eligible patients will be randomly assigned to chemotherapy plus avastin (arm A) or chemotherapy alone (arm B).
Treatment will continue until tumor response indicates suitability for surgery for liver metastases or until disease progression or unacceptable toxic effects.
The primary endpoint is the conversion rate to radical resection for liver metastases,which will be assessed by local multidisciplinary team (includes more than three liver surgeons and one radiologist) with the use of contrast-enhanced CT or MRI after 4 cycles and then every other 4 cycles up to 12 cycles.
To provide an objective assessment of changes in resectability, radiological images will be presented by a radiologist to more than 3 liver surgeons, who are blinded to the clinical data.
Patients will be considered resectable if 50% or more of surgeons vote for radical resection of LM.
For patients whose liver-metastases are assessed resectable, resection should be scheduled to be performed within 2~3 weeks of the last treatment cycle.
Following resection, patients will be advised to continue the same therapeutic regimen until the treatments reach a sum of 12 cycles.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
241
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Shanghai
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Shanghai, Shanghai, Kina, 200000
- Zhongshan Hospital, Fudan University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 and ≤ 75 years;
- Primary tumour was histologically confirmed colorectal adenocarcinoma;
- Together with clinical or radiological evidence of first occurrence of non-resectable liver-only metastases
- With evidence of tumor RAS gene mutant status;
- With at least one measurable tumor.
- Performance status (ECOG) 0~1
- A life expectancy of ≥ 3 months
- Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
- Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either AST or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
- Written informed consent for participation in the trial.
Exclusion Criteria:
- Previous exposure to target therapy, chemotherapy, radiotherapy or intervention therapy for colorectal liver metastases.
- Known or suspected extrahepatic metastases.
- Patients with known hypersensitivity reactions to any of the components of the study treatments.
- Having previously participated in a study which included a possibility of being allocated to avastin therapy (whether or not the patient actually received avastin)
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or left ventricular ejection fraction (LVEF) below the institutional range of normal
- Acute or sub-acute intestinal occlusion
- Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
- Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- Known drug abuse/ alcohol abuse
- Legal incapacity or limited legal capacity
- Pre-existing peripheral neuropathy.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
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: ARM A
patients received avastin in combination with mFOLFOX6
|
Drug: avastin On day 1 of a 14 day treatment cycle, patients received a 2-hour infusion of avastin (5mg/kg) followed by chemotherapy of mFOLFOX6 until progressive disease or unacceptable toxicity.
Andre navne:
mFOLFOX-6 (oxaliplatin, 85mg/m2 on day 1 infused during 2 hours;LV400mg/m2 on days 1 infused during 2 hours, followed by FU 400 mg/m2 intravenous bolus then 2400 mg/m2 continuous infusion for 46 hours)
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|
Aktiv komparator: ARM B
Patients received mFOLFOX6 alone
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mFOLFOX-6 (oxaliplatin, 85mg/m2 on day 1 infused during 2 hours;LV400mg/m2 on days 1 infused during 2 hours, followed by FU 400 mg/m2 intravenous bolus then 2400 mg/m2 continuous infusion for 46 hours)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
the rate of patients converted to resection for liver metastases
Tidsramme: 3 years
|
To explore whether avastin in combination with chemotherapy as treatment could improve the resection rate in patients with RAS mutant-type, unresectable colorectal liver-limited metastases compared with chemotherapy alone.
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3 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
progression free survival
Tidsramme: 3 years
|
PFS will be defined as the period from the first day of avastin treatment or chemotherapy to the date of disease progression (PD) or to death.
Patients without PD who discontinued the study for any reason is censored at the last on-study tumor assessment date.or
distant(i.e.
metastasis) disease recurrence or death.
|
3 years
|
|
overall survival
Tidsramme: 3 years
|
OS will be calculated from randomization to death from any cause or the date of the last follow-up, at which point the data will be censored.
|
3 years
|
|
tumor response
Tidsramme: 3 years
|
3 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. oktober 2013
Primær færdiggørelse (Faktiske)
1. december 2017
Studieafslutning (Faktiske)
1. juni 2019
Datoer for studieregistrering
Først indsendt
23. september 2013
Først indsendt, der opfyldte QC-kriterier
29. oktober 2013
Først opslået (Skøn)
30. oktober 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. december 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. december 2019
Sidst verificeret
1. december 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Patologiske processer
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tyktarmssygdomme
- Tarmsygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Neoplastiske processer
- Kolorektale neoplasmer
- Neoplasma Metastase
- Lægemidlers fysiologiske virkninger
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Bevacizumab
Andre undersøgelses-id-numre
- ACCMCLM
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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