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An Observational Study of Bevacizumab in Combination With 5-FU-Based Chemotherapy in Chinese Participants With Metastatic Colorectal Cancer

22. juli 2016 opdateret af: Hoffmann-La Roche

A Multi-center Observational Study of Bevacizumab Plus 5-FU Based Chemotherapy as First Line and Second Line Treatment for Chinese Patients With Metastatic Colorectal Cancer (ML25391)

This observational study will evaluate the safety and efficacy of Bevacizumab in combination with 5-Fluorouracil based chemotherapy as first-line and second-line therapy in Chinese participants with metastatic colorectal cancer. Data will be collected from each participant for up to 3 years.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

609

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
      • Beijing, Kina, 100083
      • Beijing, Kina, 100071
      • Changzhou, Kina, 213003
      • Chengdu, Kina, 610041
      • Fuzhou, Kina, 350014
      • Guangzhou, Kina, 510080
      • Guangzhou, Kina, 510515
      • Guangzhou, Kina, 510655
      • Hangzhou, Kina, 310003
      • Hangzhou, Kina, 310022
      • Hangzhou, Kina, 310009
      • Harbin, Kina, 150040
      • Jinan, Kina, 250117
      • Nanjing, Kina
      • Nanjing, Kina, 210009
      • Nanjing, Kina, 210036
      • Nanning, Kina, 530021
      • Shanghai, Kina, 200032
      • Shanghai, Kina, 200003
      • Shenyang, Kina, 110001
      • Shenyang, Kina, 110042
      • Wuhan, Kina, 430079
      • Xi'an, Kina, 710032
      • Xiamen, Kina, 361004

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Participants with metastatic colorectal cancer receiving first-line therapy with Bevacizumab in combination with 5-FU-based chemotherapy

Beskrivelse

Inclusion Criteria:

  • Adult Chinese participants, >/= 18 years of age
  • Histologically confirmed and previously untreated metastatic colorectal cancer
  • Initiated on treatment with Bevacizumab (in combination with 5-FU based chemotherapy) according to locally approved Bevacizumab China package insert
  • Documented participant with medical records

Exclusion Criteria:

  • Recent history of serious hemorrhage or hemoptysis of >/= 1/2 teaspoon of red blood
  • Proteinuria at baseline (>/=2 grams / 24 hours)
  • Major surgical procedure within 28 days prior to study treatment start, not fully healed wounds
  • Pregnant or lactating women

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
First Line Treatment
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
Second Line Treatment
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Adverse Events
Tidsramme: 36 months
An adverse event (AE) is defined as any untoward medical occurrence in a participant after administration of a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.
36 months
Percentage of Participants With Serious Adverse Events
Tidsramme: 36 months
A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose was fatal, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant, or required intervention to prevent one or other of the outcomes listed above.
36 months
Percentage of Participants With Adverse Events of Special Interest
Tidsramme: 36 months
36 months
Percentage of Participants With Bevacizumab-Related Adverse Events
Tidsramme: 36 months
36 months
Percentage of Participants With Bevacizumab-related Serious Adverse Events
Tidsramme: 36 months
36 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving an Overall Response
Tidsramme: 36 months
Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions.
36 months
Progression-free Survival
Tidsramme: 36 months
Progression-free-survival (PFS) was defined as the time from the date when the participant signed the informed consent form to the time of first documented disease progression or death, whichever occurred first.
36 months
One-year Progression-free Survival Rate
Tidsramme: 1 year
One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year.
1 year
One-year Survival Rate
Tidsramme: 1 year
1 year
Percentage of Participants Achieving an Overall Response Per Kirsten Rat Sarcoma Viral (KRAS) Oncogene Subgroup
Tidsramme: 36 months
Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.
36 months
One-year Progression-free Survival Rate Per KRAS Subgroup
Tidsramme: 1 year
One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.
1 year
One-year Survival Rate by the KRAS Subgroup
Tidsramme: 1 year
1 year
Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup
Tidsramme: Up to 36 Months
Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' chemotherapy regimen subgroup.
Up to 36 Months
One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup
Tidsramme: 1 year
One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' chemotherapy regimen subgroup.
1 year
One-year Survival Rate by the Chemotherapy Regimen Subgroup
Tidsramme: 1 year
1 year
Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire
Tidsramme: Up to 36 Months
Quality of life was assessed at baseline and every three months after treatment by the EORTC QLQ-C30 questionnaire. The possible score range was 0 to 100, with a higher score indicating better functioning.
Up to 36 Months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

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

1. marts 2011

Primær færdiggørelse (Faktiske)

1. marts 2015

Studieafslutning (Faktiske)

1. marts 2015

Datoer for studieregistrering

Først indsendt

18. marts 2011

Først indsendt, der opfyldte QC-kriterier

21. marts 2011

Først opslået (Skøn)

22. marts 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. september 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML25391

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Sponsor / samarbejdspartnere

Placeringer

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