Pancreatic NeoplasmsaLIVENCT02342847
Observational Study of Quality of Live in Patients With Metastatic Pancreatic Cancer
An observational study of Pancreatic Neoplasms, run by Celgene at 12 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- N/A (non-interventional study)
- How many people
- 120 participants
- Where
- 12 sitesSpain
- Study dates
- 10 Dec 2014to 16 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Germans Trias i Pujol
Badalona, Catalonia, 08916
Hospital del Mar
Barcelona, Catalonia, 08003
Hospital Vall d´Hebron
Barcelona, Catalonia, 08035
Hospital Santa Creu i Sant Pau
Barcelona, 008026
Hospital Universitario Burgos
Burgos, Castille and León, 09006
Hospital Universitario Josep Trueta de Girona
Girona, Catalonia, 17007
Hospital Duran I Reynals (ICO Bellvitge)
L'Hospitalet de Llobregat, Catalonia, 08908
Complejo Asistencial León
León, Castille and León, 24071
Hospital del Bierzo
León, Castille and León, 24404
Hospital San Joan Reus
Reus, Catalonia, 43204
Hospital de Sabadell ( Parc Taulí)
Sabadell, Catalonia, 08208
Hospital Universitario Salamanca
Salamanca, Castille and León, 37007
About this study
Official title: Observational Cohort Study of Health-related Quality of Life in Patients Initiating Treatment With Chemotherapy for 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.
- Conditions
- Pancreatic Neoplasms
- Being tested
- N/A (non-interventional study)
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N/A (non-interventional study)Other
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: N/A (non-interventional study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: Up to 6 months
Secondary outcomes (22)
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.
Measured: 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.
Measured: Up to 6 months
Percentage of improved Karnofsky index
Percentage of patients with improved Karnofsky basal index per month of treatment
Measured: 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)
Measured: Up to 6 months
Percentage of improved Karnofsky index
Percentage of patients with improved Karnofsky basal index per month of treatment
Measured: Up to 6 months
Percentage of worse Karnofsky index
Percentage of patients with worse Karnofsky basal index per month of treatment
Measured: Up to 6 months
Mean of improvement of Karnofsky index
Mean time to improvement of Karnofsky index from baseline
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Up to 6 months
Duration of treatment
Average duration of treatment with chemotherapy for metastatic pancreatic cancer.
Measured: Up to 18 months
Average dose of treatment (minimum, maximum)
Average dose (minimum, maximum) of the treatment with chemotherapy for metastatic pancreatic cancer.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 30 months
Hematologic toxicity
Number of participants with Grade 3-4 hematologic toxicity
Measured: Up to 30 months
Radiological examinations
Number of radiological examinations per patient during treatment.
Measured: Up to 18 months
Laboratory assessments
Number of laboratory assessments per patient during treatment
Measured: Up to 18 months
Physical examinations
Number of physical examinations per patient during treatment.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study start10 Dec 2014
- Primary completion9 Nov 2016
- Study completion16 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lorena Pellín, MD, Study director, Celgene Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342847
- Sponsor's protocol ID
- CEL-CPM-2014-01
- Acronym
- aLIVE
- Status last verified
- Jan 2019
- First submitted
- 30 Dec 2014
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cohort Study of Health-related Quality of Life in Patients Initiating Treatment With Chemotherapy for Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02342847
- Acronym / sponsor ID
- aLIVE / CEL-CPM-2014-01
- Conditions
- Pancreatic Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2014 (actual)
- Primary completion
- 9 Nov 2016 (actual)
- Study completion
- 16 Nov 2018 (actual)
- First posted
- 21 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pateints with metastatic pancreatic cancer | – | Other: N/A (non-interventional study)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.*
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N/A (non-interventional study) | Other | Pateints with metastatic pancreatic cancer |
Primary outcome
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.
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
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.
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
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.
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
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)
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)
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)
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)
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.
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.
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)
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
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.
22 secondary outcomes
Feasibility of using the EORTC QLQ-C30 and EQ-5D questionnaires
Time frame: Up to 6 months
Average variation of Karnofsky index versus EORTC QLQ-C30 score
Time frame: Up to 6 months
Percentage of improved Karnofsky index
Time frame: Up to 18 months
Average variation of Karnofsky index versus EQ-5D score
Time frame: Up to 6 months
Percentage of improved Karnofsky index
Time frame: Up to 6 months
Percentage of worse Karnofsky index
Time frame: Up to 6 months
Mean of improvement of Karnofsky index
Time frame: Up to 6 months
Mean of deterioration of Karnofsky index
Time frame: Up to 6 months
Weight variation
Time frame: Up to 6 months
Number of patients who use Painkillers 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).
Time frame: Up to 6 months
Duration of treatment
Time frame: Up to 18 months
Average dose of treatment (minimum, maximum)
Time frame: Up to 18 months
Delayed/Reduced dose treatment
Time frame: Up to 18 months
Rate response based on the treatment given.
Time frame: Up to 18 months
Response to treatment determined by (Response Evaluation Criteria in Solid Tumors )RECIST v.1.1.
Time frame: Up to 18 months
Overall survival determined by RECIST v.1.1.
Time frame: Up to 30 months
Progression-free survival determined by RECIST v.1.1
Time frame: Up to 30 months
Hematologic toxicity
Time frame: Up to 30 months
Radiological examinations
Time frame: Up to 18 months
Laboratory assessments
Time frame: Up to 18 months
Physical examinations
Time frame: Up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
Related trials for Pancreatic Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorena Pellín, MD study director
Celgene Spain
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasms, run by Celgene at 12 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with mild improvement in Quality of life questionnaire - Current standard version 3.0 (EORTC QLQ-C30) scoring (time frame: Up to 18 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.