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Observational Study of Quality of Live in Patients With Metastatic Pancreatic Cancer (aLIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02342847
Recruitment Status : Completed
First Posted : January 21, 2015
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:

This is an observational, post-authorization, prospective follow-up, multi-centre, national study designed to describe the spectrum of health-related quality of life in patients with metastatic pancreatic cancer previously untreated with chemotherapy This study is designed to observe patients treated in routine clinical practice, without the exclusion limitations of a clinical trial. Patients will be enrolled in 7 Spanish sites. In all cases, the decision to treat patients will be performed prior to the decision to include the patient in the study.

Given the observational nature of the study, follow-up of patients will be performed according to standard clinical practice of each site.


Condition or disease Intervention/treatment
Pancreatic Neoplasms Other: N/A (non-interventional study)

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Cohort Study of Health-related Quality of Life in Patients Initiating Treatment With Chemotherapy for Metastatic Pancreatic Cancer
Actual Study Start Date : December 10, 2014
Actual Primary Completion Date : November 9, 2016
Actual Study Completion Date : November 16, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pateints with metastatic pancreatic cancer

Patients diagnosed with metastatic pancreatic cancer confirmed histologically or cytologically, who will be treated with chemotherapy as first-line treatment of metastatic pancreatic cancer.

This study is designed to observe patients treated in routine clinical practice, without the exclusion limitations of a clinical trial. The decision to treat patients will be performed prior to the decision to include the patient in the study.

The follow-up of patients will be performed according to standard clinical practice of each site

Other: N/A (non-interventional study)



Primary Outcome Measures :
  1. Patients with mild improvement in Quality of life questionnaire - Current standard version 3.0 (EORTC QLQ-C30) scoring [ Time Frame: Up to 18 months ]
    Number of participants with mild improvement. Mild improvement in QoL : (increased from ≥ 5 to <10 points), moderate (increase of between ≥ 10 and <20 points), and high (increase ≥ 20 points) in EORTC QLQ-C30) scoring.

  2. Patients with mild impairment of EORTC QLQ-C30 scoring [ Time Frame: Up to 18 months ]
    Number of participants with mild impairment. Mild impairment of QoL (decrease from ≥ 5 to <10 points), moderate (decrease from ≥ 10 and <20 points), and severe (decrease ≥ 20 points) in EORTC QLQ-C30 scoring); mean time to improvement of Quality of Life (QoL) of mild, moderate and high in EORTC QLQ-C30 scoring

  3. Patients with moderate improvement in EORTC QLQ-C30 scoring [ Time Frame: Up to 18 months ]
    Number of participants with moderate improvement. Mild improvement in QoL (increased from ≥ 5 to <10 points), moderate (increase of between ≥ 10 and <20 points), and high (increase ≥ 20 points) in EORTC QLQ-C30) scoring.

  4. Patients with moderate impairment of EORTC QLQ-C30 scoring [ Time Frame: Up to 18 months ]
    Number of participants with moderate impairment.Mild impairment of QoL (decrease from ≥ 5 to <10 points), moderate (decrease from ≥ 10 and <20 points), and severe (decrease ≥ 20 points) in EORTC QLQ-C30 scoring); mean time to improvement of QoLof mild, moderate and high in EORTC QLQ-C30 scoring

  5. Patients with high improvement in EORTC QLQ-C3 scoring [ Time Frame: Up to 18 months ]
    Number of participants with high improvement. Mild improvement in QoL (increased from ≥ 5 to <10 points), moderate (increase of between ≥ 10 and <20 points), and high (increase ≥ 20 points) in EORTC QLQ-C30) scoring.

  6. Patients with high impairment of EORTC QLQ-C30 scoring [ Time Frame: Up to 18 months ]
    Number of participants with high impairment. Mild impairment of QoL (decrease from ≥ 5 to <10 points), moderate (decrease from ≥ 10 and <20 points), and severe (decrease ≥ 20 points) in EORTC QLQ-C30 scoring); mean time to improvement of QoLof mild, moderate and high in EORTC QLQ-C30 scoring

  7. Impairment of mild EORTC QLQ-C30 score [ Time Frame: Up to 18 months ]
    Time from enrolment to the first observation of a definite impairment of mild EORTC QLQ-C30 score (decrease from ≥ 5 to <10 points without further improvement ≥ 5 points)

  8. Deterioration of Moderate EORTC QLQ-C30 Score [ Time Frame: Up to 18 months ]
    The time from enrollment to the first observation of a definite deterioration of moderate EORTC QLQ-C30 score (decrease from ≥ 10 and <20 points without further improvement ≥ 10 points)

  9. Deterioration of severe EORTC QLQ-C30 [ Time Frame: Up to 18 months ]
    Time from enrolment to the first observation of a definite deterioration of moderate EORTC QLQ-C30 score (decrease from ≥ 10 and <20 points without further improvement ≥ 10 points)

  10. Definite deterioration of moderate EORTC QLQ-C30 Score [ Time Frame: Up to 18 months ]
    Percentage of Time from enrollment to the first observation of a definite deterioration of moderate EORTC QLQ-C30 score (decrease from ≥ 10 and <20 points without further improvement ≥ 10 points)

  11. Mild/moderate/severe decline in EORTC QLQ-C30 [ Time Frame: Up to 18 months ]
    Number of patients with mild/moderate/severe decline in EORTC QLQ-C30 on the 30th day, 2nd month, 3rd month, 4th month, 5th month and 6th month.

  12. Patients with mild/moderate/high improvement in EORTC QLQ-C30 [ Time Frame: Up to 18 months ]
    Percentage of patients with mild/moderate/high improvement in EORTC QLQ-C30 on the 30th day, 2nd month, 3rd month, 4th month, 5th month and 6th month.

  13. Deterioration of severe QLQ-C30 [ Time Frame: Up to 18 months ]
    Time from enrolment to the first observation of a definite deterioration of moderate EORTC QLQ-C30 score (decrease from ≥ 10 and <20 points without further improvement ≥ 10 points)

  14. Change from baseline of the EuroQoL Five Dimensions Questionnaire (EQ-5D). [ Time Frame: Up to 6 months ]
    Change from baseline of the EQ-5D questionnaire at 15 days, 4 weeks, 2 months, 3rd month, 4th month, 5th month and 6th month

  15. Change from baseline of the Karnofsky index [ Time Frame: Up to 6 months ]
    Change from baseline of Karnofsky index at 15 days, 4 weeks, 2 months, 3rd month, 4th month, 5th month and 6th month.


Secondary Outcome Measures :
  1. Feasibility of using the EORTC QLQ-C30 and EQ-5D questionnaires [ Time Frame: Up to 6 months ]
    Number of missing EORTC QLQ-C30 and EQ-5D questionnaires at 15 days, 4 weeks, 2 months, 3rd month, 4th month, 5th month and 6th month.

  2. Average variation of Karnofsky index versus EORTC QLQ-C30 score [ Time Frame: Up to 6 months ]
    Average variation of Karnofsky index regarding patients with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score.

  3. Percentage of improved Karnofsky index [ Time Frame: Up to 18 months ]
    Percentage of patients with improved Karnofsky basal index per month of treatment

  4. Average variation of Karnofsky index versus EQ-5D score [ Time Frame: Up to 6 months ]
    Average variation of Karnofsky index regarding patients with impairment or improvement of EQ-5D score.(0.1, 0.2, 0.3, 0.4 and 0.5 variation)

  5. Percentage of improved Karnofsky index [ Time Frame: Up to 6 months ]
    Percentage of patients with improved Karnofsky basal index per month of treatment

  6. Percentage of worse Karnofsky index [ Time Frame: Up to 6 months ]
    Percentage of patients with worse Karnofsky basal index per month of treatment

  7. Mean of improvement of Karnofsky index [ Time Frame: Up to 6 months ]
    Mean time to improvement of Karnofsky index from baseline

  8. Mean of deterioration of Karnofsky index [ Time Frame: Up to 6 months ]
    Mean time to deterioration of Karnofsky index in patients who have previously improved after treatment.

  9. Weight variation [ Time Frame: Up to 6 months ]
    Change in weight during treatment observation period (maximum 6 months). This outcome wil be measured overall and per group of patients with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score

  10. Number of patients who use Painkillers during treatment observation period (maximum 6 months) [ Time Frame: Up to 6 months ]
    Number of patients who use Painkillers during treatment observation period (maximum 6 months) with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score.

  11. Number of patients who use analgesics during treatment observation period (maximum 6 months). [ Time Frame: Up to 6 months ]
    Number of patients who use analgesics during treatment observation period (maximum 6 months) with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score.

  12. Duration of treatment [ Time Frame: Up to 18 months ]
    Average duration of treatment with chemotherapy for metastatic pancreatic cancer.

  13. Average dose of treatment (minimum, maximum) [ Time Frame: Up to 18 months ]
    Average dose (minimum, maximum) of the treatment with chemotherapy for metastatic pancreatic cancer.

  14. Delayed/Reduced dose treatment [ Time Frame: Up to 18 months ]
    Number of patients with delayed dose or with reduced dose . This outcome wil be measured overall and per group of patients with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score

  15. Rate response based on the treatment given. [ Time Frame: Up to 18 months ]
    Rate response (RR) wil be measured overall and per group of patients with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score

  16. Response to treatment determined by (Response Evaluation Criteria in Solid Tumors )RECIST v.1.1. [ Time Frame: Up to 18 months ]
    Response to treatment (RT) of the disease determined by RECIST v.1.1. . based on the treatment given This outcome wil be measured overall and per group of patients with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score

  17. Overall survival determined by RECIST v.1.1. [ Time Frame: Up to 30 months ]
    Overall survival (OS) of the disease determined by RECIST v.1.1. This outcome wil be measured overall and per group of patients with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score

  18. Progression-free survival determined by RECIST v.1.1 [ Time Frame: Up to 30 months ]
    Progression-free survival (PFS) of the disease determined by RECIST v.1.1. based on the treatment given. This outcome wil be measured overall and per group of patients with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score

  19. Hematologic toxicity [ Time Frame: Up to 30 months ]
    Number of participants with Grade 3-4 hematologic toxicity

  20. Radiological examinations [ Time Frame: Up to 18 months ]
    Number of radiological examinations per patient during treatment.

  21. Laboratory assessments [ Time Frame: Up to 18 months ]
    Number of laboratory assessments per patient during treatment

  22. Physical examinations [ Time Frame: Up to 18 months ]
    Number of physical examinations per patient during treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who will be treated with any of the first line chemotherapy treatments at the participating site approved for the treatment of Metastasic Pancreatic Cancer (MPC) will be included consecutively according to the criteria set.

Therefore, the choice of therapeutic strategy will be made according to usual clinical practice and independently by the doctor before assessing the possible involvement of the patients in the study and their corresponding inclusion in it.

The patients selected for the study must meet all inclusion criteria and none of the exclusion.

Criteria

Inclusion Criteria:

  • Patients aged ≥ 18 years.
  • Patients diagnosed with metastatic pancreatic cancer confirmed histologically or cytologically
  • Patients with Karnofsky index ≥ 70 previously untreated with chemotherapy.
  • Patients with life expectancy ≥ 6 months.
  • Patients who will be treated with chemotherapy as first-line treatment for metastatic pancreatic cancer.*
  • Informed consent in writing or orally before witnesses.

    • The decision to prescribe any treatment will be clearly dissociated from the patient's inclusion in the study. Therefore, the choice of therapeutic strategy will be made according to usual clinical practice and independently by the doctor before assessing the possible involvement of the patients in the study and their corresponding inclusion in it

Exclusion Criteria:

  • Pregnant or breastfeeding.
  • Patients who are participating in an interventional clinical trial.
  • Patients who refuse to participate in this study.
  • Patients who have no ability to understand and respond to questions related to their health.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342847


Locations
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Spain
Hospital Universitario Burgos
Burgos, Castilla Y León, Spain, 09006
Complejo Asistencial León
León, Castilla Y León, Spain, 24071
Hospital del Bierzo
León, Castilla Y León, Spain, 24404
Hospital Universitario Salamanca
Salamanca, Castilla Y León, Spain, 37007
Germans Trias i Pujol
Badalona, Cataluña, Spain, 08916
Hospital del Mar
Barcelona, Cataluña, Spain, 08003
Hospital Vall d´Hebron
Barcelona, Cataluña, Spain, 08035
Hospital Universitario Josep Trueta de Girona
Girona, Cataluña, Spain, 17007
Hospital Duran I Reynals (ICO Bellvitge)
Hospitalet de Llobregat, Cataluña, Spain, 08908
Hospital San Joan Reus
Reus, Cataluña, Spain, 43204
Hospital de Sabadell ( Parc Taulí)
Sabadell, Cataluña, Spain, 08208
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 008026
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Lorena Pellín, MD Celgene Spain

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02342847     History of Changes
Other Study ID Numbers: CEL-CPM-2014-01
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases