Clinical trial • Oncology
DEXAMETHASONE for Solid tumors
Clinical trial of DEXAMETHASONE for Solid tumors.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Solid tumors
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 10-11-2023
- First CTIS Authorization Date
- 19-02-2024
Trial design
Standard of care premedication regimen with dexamethasone versus an experimental premedication regimen without dexamethasone (no specific dexamethasone dosing/schedule for the trial arms stated).-controlled trial across 7 sites in Netherlands.
- Comparator
- Standard of care premedication regimen with dexamethasone versus an experimental premedication regimen without dexamethasone (no specific dexamethasone dosing/schedule for the trial arms stated).
- Target Sample Size
- 500
Eligibility
Recruits 500 Vulnerable populations not selected. Participants must be ≥18 years and able and willing to give written informed consent. No assent or parental consent arrangements are described..
- Pregnancy Exclusion
- Women with confirmed and ongoing pregnancy;
- Vulnerable Population
- Vulnerable populations not selected. Participants must be ≥18 years and able and willing to give written informed consent. No assent or parental consent arrangements are described.
Inclusion criteria
- {"criterion_text":"- Age ≥18 years"}
- {"criterion_text":"- Diagnosis of a solid tumor with planned treatment with paclitaxel-based chemotherapy for any indication and with any dose."}
- {"criterion_text":"- Mastery of Dutch language"}
- {"criterion_text":"- Able and willing to give written informed consent."}
Exclusion criteria
- {"criterion_text":"- Prior treatment with a paclitaxel-based regimen;"}
- {"criterion_text":"- An indication for paclitaxel in combination with moderately or highly emetogenic chemotherapy that mandates the use of dexamethasone as an anti-emetic medication (e.g., carboplatin AUC>4);"}
- {"criterion_text":"- Known hypersensitivity to paclitaxel, carboplatin, cetirizine, or excipients (e.g., benzyl alcohol);"}
- {"criterion_text":"- Concomitant use of any systemic corticosteroid for any indication other than paclitaxel premedication;"}
- {"criterion_text":"- Women with confirmed and ongoing pregnancy;"}
- {"criterion_text":"- Already participating in an exercise trial."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary outcome is the percentage of patients who experience a clinically relevant HSR (CTCAE grade ≥3) during paclitaxel infusion (Yes/No), determined prospectively by the oncology medical staff (e.g. oncologist).","definition_or_measurement_approach":"Clinically relevant HSR defined as CTCAE grade ≥3; determined prospectively by the oncology medical staff (e.g. oncologist) during paclitaxel infusion."}
Secondary endpoints
- {"endpoint_text":"- The incidence of the HSRs (all grades) as defined by (CTCAE v.5.0);","definition_or_measurement_approach":"HSRs defined and graded according to CTCAE version 5.0."}
- {"endpoint_text":"- The severity (grades) of all HSRs as defined by (CTCAE v.5.0);","definition_or_measurement_approach":"Severity graded according to CTCAE version 5.0."}
- {"endpoint_text":"- The percentage (%) of patients that can be rechallenged (according to standard of care procedures) after the occurrence of an HSR with or without dexamethasone;","definition_or_measurement_approach":"Determined as percentage of patients rechallenged per standard of care procedures after an HSR; rechallenge status recorded (with or without dexamethasone)."}
- {"endpoint_text":"- The number of paclitaxel administrations and cumulative dose (mg) until the first HSR occurrence.","definition_or_measurement_approach":"Count of paclitaxel administrations and cumulative mg dose until first recorded HSR."}
- {"endpoint_text":"- The incidence and severity of adverse events related to dexamethasone measured through the validated Dexamethasone Symptom Questionnaire (DSQ)21;","definition_or_measurement_approach":"Adverse events related to dexamethasone assessed using the validated Dexamethasone Symptom Questionnaire (DSQ)."}
- {"endpoint_text":"- The patient quality of life measured using the EuroQol-5 dimensions-5 levels (EQ-5D-5L) and European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30) scorings tools);","definition_or_measurement_approach":"Quality of life measured using EQ-5D-5L and EORTC QLQ-C30 instruments."}
- {"endpoint_text":"- The total cost of treatment of both premedication regimens from a healthcare and societal perspective.","definition_or_measurement_approach":"Health economic evaluation comparing total treatment costs of premedication regimens from healthcare and societal perspectives."}
Recruitment
- Planned Sample Size
- 500
- Recruitment Window Months
- 35
- Consent Approach
- Participants must be able and willing to give written informed consent. Study requires mastery of Dutch language. Participants are adults (≥18 years); consent provided by the participant. No assent or parental consent arrangements described; languages of consent documents not explicitly stated but Dutch language mastery is required.
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 500
Netherlands
- Earliest CTIS Part Ii Submission Date
- 30-01-2024
- Latest Decision Or Authorization Date
- 09-05-2025
- Processing Time Days
- 465
- Number Of Sites
- 7
- Number Of Participants
- 500
Sites
- Site Name
- Groene Hart Ziekenhuis
- Department Name
- Department of Internal Medicine
- Contact Person Name
- Wendy Van der Deure-Gielisse
- Contact Person Email
- wendy.van.der.deure@ghz.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Department of Hospital Pharmacy
- Contact Person Name
- Roelof van Leeuwen
- Contact Person Email
- r.w.f.vanleeuwen@erasmusmc.nl
- Site Name
- Spaarne Gasthuis Stichting
- Department Name
- Department of Oncology
- Contact Person Name
- Aart Beeker
- Contact Person Email
- ABeeker@spaarnegasthuis.nl
- Site Name
- Maxima Medisch Centrum
- Department Name
- Department of Medical Oncology
- Contact Person Name
- Wouter Dercksen
- Contact Person Email
- lokaleuitvoerbaarheid@mmc.nl
- Site Name
- Alrijne Zorggroep Stichting
- Department Name
- Department of Internal Medicine
- Contact Person Name
- Leontine Spierings
- Contact Person Email
- leaspierings@alrijne.nl
- Site Name
- Amphia Hospital
- Department Name
- Department of Hospital Pharmacy
- Contact Person Name
- Nikki De Rouw
- Contact Person Email
- nderouw@amphia.nl
- Site Name
- Groene Hart Ziekenhuis (duplicate entry not present) - (only 6 unique names shown in list but total sites reported as 7)
Sponsor
Primary sponsor
- Full Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- Dexamethasone 4 mg tablets
- Active Substance
- DEXAMETHASONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation PL 12762/0618, euMpNumber PRD7227714)
- Maximum Dose
- 8 mg
- Investigational Product Name
- Dexamethasone Phosphate 4 mg/ml Solution for Injection
- Active Substance
- DEXAMETHASONE SODIUM PHOSPHATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised (marketing authorisation PA 0822/201/001, euMpNumber PRD1172938)
- Maximum Dose
- 10 mg
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