Clinical trial NCT02342847: Observational Study of Quality of Live in Patients With Metastatic Pancreatic Cancer
Official title: Observational Cohort Study of Health-related Quality of Life in Patients Initiating Treatment With Chemotherapy for Metastatic Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Neoplasms
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2015-01-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Patients with mild improvement in Quality of life questionnaire - Current standard version 3.0 (EORTC QLQ-C30) scoring
timeFrame: Up to 18 months
measure: Patients with mild impairment of EORTC QLQ-C30 scoring
timeFrame: Up to 18 months
measure: Patients with moderate improvement in EORTC QLQ-C30 scoring
timeFrame: Up to 18 months
measure: Patients with moderate impairment of EORTC QLQ-C30 scoring
timeFrame: Up to 18 months
measure: Patients with high improvement in EORTC QLQ-C3 scoring
timeFrame: Up to 18 months
measure: Patients with high impairment of EORTC QLQ-C30 scoring
timeFrame: Up to 18 months
measure: Impairment of mild EORTC QLQ-C30 score
timeFrame: Up to 18 months
measure: Deterioration of Moderate EORTC QLQ-C30 Score
timeFrame: Up to 18 months
measure: Deterioration of severe EORTC QLQ-C30
timeFrame: Up to 18 months
measure: Definite deterioration of moderate EORTC QLQ-C30 Score
timeFrame: Up to 18 months
measure: Mild/moderate/severe decline in EORTC QLQ-C30
timeFrame: Up to 18 months
measure: Patients with mild/moderate/high improvement in EORTC QLQ-C30
timeFrame: Up to 18 months
measure: Deterioration of severe QLQ-C30
timeFrame: Up to 18 months
measure: Change from baseline of the EuroQoL Five Dimensions Questionnaire (EQ-5D).
timeFrame: Up to 6 months
measure: Change from baseline of the Karnofsky index
timeFrame: Up to 6 months
Secondary outcomes:
measure: Feasibility of using the EORTC QLQ-C30 and EQ-5D questionnaires
timeFrame: Up to 6 months
measure: Average variation of Karnofsky index versus EORTC QLQ-C30 score
timeFrame: Up to 6 months
measure: Percentage of improved Karnofsky index
timeFrame: Up to 18 months
measure: Average variation of Karnofsky index versus EQ-5D score
timeFrame: Up to 6 months
measure: Percentage of improved Karnofsky index
timeFrame: Up to 6 months
measure: Percentage of worse Karnofsky index
timeFrame: Up to 6 months
measure: Mean of improvement of Karnofsky index
timeFrame: Up to 6 months
measure: Mean of deterioration of Karnofsky index
timeFrame: Up to 6 months
measure: Weight variation
timeFrame: Up to 6 months
measure: Number of patients who use Painkillers during treatment observation period (maximum 6 months)
timeFrame: Up to 6 months
measure: Number of patients who use analgesics during treatment observation period (maximum 6 months).
timeFrame: Up to 6 months
measure: Duration of treatment
timeFrame: Up to 18 months
measure: Average dose of treatment (minimum, maximum)
timeFrame: Up to 18 months
measure: Delayed/Reduced dose treatment
timeFrame: Up to 18 months
measure: Rate response based on the treatment given.
timeFrame: Up to 18 months
measure: Response to treatment determined by (Response Evaluation Criteria in Solid Tumors )RECIST v.1.1.
timeFrame: Up to 18 months
measure: Overall survival determined by RECIST v.1.1.
timeFrame: Up to 30 months
measure: Progression-free survival determined by RECIST v.1.1
timeFrame: Up to 30 months
measure: Hematologic toxicity
timeFrame: Up to 30 months
measure: Radiological examinations
timeFrame: Up to 18 months
measure: Laboratory assessments
timeFrame: Up to 18 months
measure: Physical examinations
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Hospital Universitario Burgos
state: Castilla Y León
city: León
country: Spain
facility: Complejo Asistencial León
state: Castilla Y León
city: León
country: Spain
facility: Hospital del Bierzo
state: Castilla Y León
city: Salamanca
country: Spain
facility: Hospital Universitario Salamanca
state: Castilla Y León
city: Badalona
country: Spain
facility: Germans Trias i Pujol
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebron
state: Cataluña
city: Girona
country: Spain
facility: Hospital Universitario Josep Trueta de Girona
state: Cataluña
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Duran I Reynals (ICO Bellvitge)
state: Cataluña
city: Reus
country: Spain
facility: Hospital San Joan Reus
state: Cataluña
city: Sabadell
country: Spain
facility: Hospital de Sabadell ( Parc Taulí)
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
Study officials:
affiliation: Celgene Spain
name: Lorena Pellín, MD
role: STUDY_DIRECTOR
References: