Pancreatic Neoplasms Clinical Trial
— TRUSTOfficial title:
Non-interventional Observational Post-authorization Study to Assess Clinical and Patient Reported Outcomes With Nab-paclitaxel in Combination With Gemcitabine in Routine Clinical Practice Treating Pancreatic Cancer (TRUST)
Verified date | September 2019 |
Source | Celgene |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The objective of the study is to prospectively assess the use and treatment outcomes of nab-paclitaxel plus gemcitabine in pancreatic ductal adenocarcinoma in the Netherlands. Additional objectives are to monitor the incidence and reversibility of neuropathy during treatment, to assess the patient's Quality of life when treated with nab-paclitaxel/gemcitabine and to evaluate the use of resources that come with treating metastatic pancreatic cancer.
Status | Terminated |
Enrollment | 44 |
Est. completion date | November 28, 2017 |
Est. primary completion date | November 28, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients over 18 years of age who understand and voluntarily sign an informed consent form. - Patients treated for pancreatic adenocarcinoma. Exclusion Criteria: - Patients currently treated for metastatic pancreatic cancer with other therapy than nab-paclitaxel plus gemcitabine - Refusal to participate in the study. - Women who are pregnant or breast-feeding. - Hypersensitivity to the active substance or to any of the excipients. - Participation in interventional trials during the period of treatment with nab-paclitaxel |
Country | Name | City | State |
---|---|---|---|
Netherlands | Academic Medical Centre | Amsterdam | North- Holland |
Netherlands | BovenIJ Ziekenhuis | Amsterdam | North- Holland |
Netherlands | Rijnstate Ziekenhuis | Arnhem | Gelderland |
Netherlands | Amphia ziekenhuis | Breda | Gelderland |
Netherlands | Albert Schweitzer Ziekenhuis | Dordrecht | South-Holland |
Netherlands | Gelderse Vallei | Ede | North Brabant |
Netherlands | Martini Ziekenhuis | Groningen | |
Netherlands | Spaarne Gasthuis | Haarlem | North Holland |
Netherlands | Ziekenhuis de Tjongerschans | Heerenveen | Friesland |
Netherlands | Elkerliek Ziekenhuis | Helmond | North Brabant |
Netherlands | Tergooi | Hilversum | North Holland |
Netherlands | LUMC | Leiden | South-Holland |
Netherlands | Antonius Ziekenhuis Sneek | Sneek | Friesland |
Netherlands | Zorgsaam Zeeuws -Vlaanderen | Terneuzen | Zeeland |
Netherlands | HagaZiekenhuis | The Hague | South- Holland |
Netherlands | UMC Utrecht | Utrecht | |
Netherlands | Maxima Medisch Centrum | Veldhoven | North-Brabant |
Netherlands | Isala | Zwolle | Overijssel |
Lead Sponsor | Collaborator |
---|---|
Celgene |
Netherlands,
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Hegewisch-Becker S, Aldaoud A, Wolf T, Krammer-Steiner B, Linde H, Scheiner-Sparna R, Hamm D, Jänicke M, Marschner N; TPK-Group (Tumour Registry Pancreatic Cancer). Results from the prospective German TPK clinical cohort study: Treatment algorithms and survival of 1,174 patients with locally advanced, inoperable, or metastatic pancreatic ductal adenocarcinoma. Int J Cancer. 2019 Mar 1;144(5):981-990. doi: 10.1002/ijc.31751. Epub 2018 Oct 3. — View Citation
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Pelzer U, Wislocka L, Jühling A, Striefler J, Klein F, Roemmler-Zehrer J, Sinn M, Denecke T, Bahra M, Riess H. Safety and efficacy of Nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer suffering from cholestatic hyperbilirubinaemia-A retrospective analysis. Eur J Cancer. 2018 Sep;100:85-93. doi: 10.1016/j.ejca.2018.06.001. Epub 2018 Jul 4. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | Survival is defined as the time from the first dose of nab-paclitaxel in combination with gemcitabine date to the date of death (any cause). | Up to approximately 3 years | |
Primary | Adverse Event (AE) | Adverse events will be classified using the MedDRA classification system. The severity of the toxicities will be graded according to the NCI CTCAE VERSION 4.03 whenever possible. | Up to approximately 3 years | |
Secondary | Change from baseline in the EORTC-QLQ-CIPN-20 (European Organization for Research and Treatment of Cancer Quality of Life Instrument In Patients With Chemotherapy Induced Peripheral Neuropathy ) | The instrument contains 20 questions evaluating sensory, motor, and autonomic symptoms, and has been validated as an assessment tool for CIPN. All scale scores are linearly converted to a 0-100 scale, with higher scores indicating more symptom burden. | up to approximately 3 years | |
Secondary | Change from baseline in the EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Instrument) | The instrument contains 30 questions evaluating quality of life in cancer patients. | up to approximately 3 years | |
Secondary | Change from baseline in the EuroQuality of Life : EQ5D-3L | A generic Quality of Life (QOL) instrument to measure and evaluate health status outcomes. The 3 Level (3L) version describes general health based on five distinct dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 Levels (indicating no problem, some or moderate problem and extreme problem). | up to approximately 3 years | |
Secondary | Evaluate the incidence of neuropathy - grade 1-5 | Descriptive analysis of incidence and severity of neuropathy according to physicians assessment | up to approximately 3 years | |
Secondary | Evaluate reversibility of neuropathy to Gr =1 | The time to decrease of neuropathy to Gr =1 using the NCI CTCAE grading scale. | up to approximately 3 years | |
Secondary | Evaluate the resources utilized for treatment of pancreatic adenocarcinoma with the combination nab-paclitaxel/gemcitabine in routine clinical practice | Per hospital, one generalized questionnaire will be filled in to evaluate the use of utilized resources when treating metastatic pancreatic cancer within routine clinical practice. | up to approximately 3 years |
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