Observational Study Of Quality Of Live In Patients With Metastatic Pancreatic Cancer

Study Overview

Observational Study of Quality of Live in Patients With Metastatic Pancreatic Cancer

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.

N/A

Pancreatic Neoplasms

OTHER: N/A (non-interventional study)

CEL-CPM-2014-01

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-12-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-01-23
First Submitted that Met QC Criteria 2015-01-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-01-25
First Posted (ACTUAL) 2015-01-21	Results First Posted N/A	Last Verified 2019-01

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	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 c	OTHER: N/A (non-interventional study)

Participant Group/Arm

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 c

OTHER: N/A (non-interventional study)

Primary Outcome Measures	Measure Description	Time Frame
Patients with mild improvement in Quality of life questionnaire - Current standard version 3.0 (EORTC QLQ-C30) scoring	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.	Up to 18 months
Patients with mild impairment of EORTC QLQ-C30 scoring	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	Up to 18 months
Patients with moderate improvement in EORTC QLQ-C30 scoring	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.	Up to 18 months
Patients with moderate impairment of EORTC QLQ-C30 scoring	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	Up to 18 months
Patients with high improvement in EORTC QLQ-C3 scoring	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.	Up to 18 months
Patients with high impairment of EORTC QLQ-C30 scoring	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	Up to 18 months
Impairment of mild EORTC QLQ-C30 score	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)	Up to 18 months
Deterioration of Moderate EORTC QLQ-C30 Score	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)	Up to 18 months
Deterioration of severe EORTC QLQ-C30	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)	Up to 18 months
Definite deterioration of moderate EORTC QLQ-C30 Score	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)	Up to 18 months
Mild/moderate/severe decline in EORTC QLQ-C30	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.	Up to 18 months
Patients with mild/moderate/high improvement in EORTC QLQ-C30	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.	Up to 18 months
Deterioration of severe QLQ-C30	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)	Up to 18 months
Change from baseline of the EuroQoL Five Dimensions Questionnaire (EQ-5D).	Change from baseline of the EQ-5D questionnaire at 15 days, 4 weeks, 2 months, 3rd month, 4th month, 5th month and 6th month	Up to 6 months
Change from baseline of the Karnofsky index	Change from baseline of Karnofsky index at 15 days, 4 weeks, 2 months, 3rd month, 4th month, 5th month and 6th month.	Up to 6 months

Secondary Outcome Measures	Measure Description	Time Frame
Feasibility of using the EORTC QLQ-C30 and EQ-5D questionnaires	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.	Up to 6 months
Average variation of Karnofsky index versus EORTC QLQ-C30 score	Average variation of Karnofsky index regarding patients with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score.	Up to 6 months
Percentage of improved Karnofsky index	Percentage of patients with improved Karnofsky basal index per month of treatment	Up to 18 months
Average variation of Karnofsky index versus EQ-5D score	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)	Up to 6 months
Percentage of improved Karnofsky index	Percentage of patients with improved Karnofsky basal index per month of treatment	Up to 6 months
Percentage of worse Karnofsky index	Percentage of patients with worse Karnofsky basal index per month of treatment	Up to 6 months
Mean of improvement of Karnofsky index	Mean time to improvement of Karnofsky index from baseline	Up to 6 months
Mean of deterioration of Karnofsky index	Mean time to deterioration of Karnofsky index in patients who have previously improved after treatment.	Up to 6 months
Weight variation	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	Up to 6 months
Number of patients who use Painkillers during treatment observation period (maximum 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.	Up to 6 months
Number of patients who use analgesics during treatment observation period (maximum 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.	Up to 6 months
Duration of treatment	Average duration of treatment with chemotherapy for metastatic pancreatic cancer.	Up to 18 months
Average dose of treatment (minimum, maximum)	Average dose (minimum, maximum) of the treatment with chemotherapy for metastatic pancreatic cancer.	Up to 18 months
Delayed/Reduced dose treatment	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	Up to 18 months
Rate response based on the treatment given.	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	Up to 18 months
Response to treatment determined by (Response Evaluation Criteria in Solid Tumors )RECIST v.1.1.	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	Up to 18 months
Overall survival determined by RECIST v.1.1.	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	Up to 30 months
Progression-free survival determined by RECIST v.1.1	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	Up to 30 months
Hematologic toxicity	Number of participants with Grade 3-4 hematologic toxicity	Up to 30 months
Radiological examinations	Number of radiological examinations per patient during treatment.	Up to 18 months
Laboratory assessments	Number of laboratory assessments per patient during treatment	Up to 18 months
Physical examinations	Number of physical examinations per patient during treatment.	Up to 18 months

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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.

Collaborators and Investigators

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

Investigators

STUDY_DIRECTOR: Lorena Pellín, MD, Celgene Spain

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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