Retrospective Data Collection: Post Study Treatment Anticancer Therapy From IMELDA MO22223

September 6, 2017 updated by: Hoffmann-La Roche

Retrospective Data Collection: Post Study Treatment Anticancer Therapy From All Randomized Patients Involved in IMELDA MO22223

This study aims to understand better the effective results from the IMELDA MO22223 P-trial (NCT00929240) and see if the anti-cancer therapies given during its follow-up time after study treatments were terminated possibly had an effect on efficacy results.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
185

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • CE
      • Fortaleza, CE, Brazil, 60336-550
        • Crio - Centro Regional Integrado de Oncologia
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20560-120
        • Instituto Nacional de Cancer - INCa; Oncologia
    • RS
      • Ijui, RS, Brazil, 98700-000
        • Hospital de Caridade de Ijui; Oncologia
      • Porto Alegre, RS, Brazil, 90035-003
        • Hospital das Clinicas - UFRGS
    • SP
      • Jau, SP, Brazil, 17210-080
        • Hospital Amaral Carvalho
      • Santo Andre, SP, Brazil, 09060-650
        • Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia
      • Sao Paulo, SP, Brazil, 01246-000
        • Instituto do Câncer do Estado de São Paulo - ICESP
      • Sao Paulo, SP, Brazil, 08270-070
        • Hospital Santa Marcelina;Oncologia
  • France
      • Besancon, France, 25030
        • HOPITAL JEAN MINJOZ; Oncologie
      • Chartres, France, 28018
        • Chg de Chartres Hopital Louis Pasteur; Pneumologie
      • Hyeres, France, 83400
        • Clinique Sainte Marguerite; Oncologie Medicale
      • Lille, France, 59000
        • Centre Bourgogne, Service de Radiotherapie
      • Paris, France, 75231
        • Institut Curie; Oncologie Medicale
      • Paris, France, 75970
        • HOPITAL TENON; Cancerologie Medicale
      • Perigueux, France, 24000
        • Clinique Francheville; Radiotherapie
      • Strasbourg, France, 67000
        • Institut D Oncologie Medical
  • India
    • Delhi
      • New Delhi, Delhi, India, 110085
        • Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Tata Memorial Hospital; Dept of Medical Oncology
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Università Federico II; Dip. Di Endocrinologia ed Oncologia Molecolare e Clinica
    • Liguria
      • Genova, Liguria, Italy, 16132
        • Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico
    • Puglia
      • Brindisi, Puglia, Italy, 72100
        • Ospedale Antonio Perrino; Oncologia Medica
  • Spain
      • Jaen, Spain, 23007
        • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
      • Malaga, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
      • Toledo, Spain, 45004
        • Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
      • Valencia, Spain, 46026
        • Hospital Universitario la Fe; Servicio de Oncologia
    • Alicante
      • Alcoy, Alicante, Spain, 03804
        • Hospital Virgen de los Lirios; Servicio de Oncologia
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
    • Ciudad Real
      • Alcazar de S. Juan, Ciudad Real, Spain, 13600
        • Complejo Hospitalario la Mancha Centro;Servicio Oncologia
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Hospital de Cruces; Servicio de Oncologia
  • Turkey
      • Ankara, Turkey, 06500
        • Gazi Uni Medical Faculty Hospital; Oncology Dept
      • Antalya, Turkey, 07070
        • Akdeniz University Medical Faculty; Medical Oncology Department
      • Sıhhiye, ANKARA, Turkey, 06100
        • Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All participants randomized in IMELDA (MO22223)

Description

Inclusion Criteria:

Having been randomized in the IMELDA MO22223 P-trial

Exclusion Criteria:

Not having been randomized in the IMELDA MO22223 P-trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Bevacizumab
Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
Other: No Intervention
No intervention administered in this study.
Bevacizumab and Capecitabine
Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
Other: No Intervention
No intervention administered in this study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy
Time Frame: Up to 78 months
Participants who had prematurely withdrawn from maintenance study treatment were reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Up to 78 months
Percentage of Participants Who Received Further Anti-Cancer Therapies After Discontinuation of Study Treatment
Time Frame: Up to 78 months
Participants who received further anti-cancer therapies after discontinuation of study treatment were reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Up to 78 months
Time From Last Maintenance Study Medication Start to Start of Further Anti-Cancer Therapy
Time Frame: Up to 78 months
Time from last maintenance study medication to the start of any further anti-cancer therapy was reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Up to 78 months
Progression Free Survival (PFS)
Time Frame: Up to 78 months
PFS was defined as the time from start of the study to the first documented occurrence of disease progression. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Up to 78 months
Overall Survival
Time Frame: Up to 78 months
Overall survival was defined as the interval between start of the study and the date of death from any cause. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Up to 78 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Reference Study ID Number: MO29587 www.roche.com/about_rouche/roche_worldwide.htm, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 22, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 22, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MO29587

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.

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