Evaluation of the omission of dexamethasone in premedication regimens during paclitaxel treatment

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

25 Jun 2024 → ongoing

Decision date (initial)

2024-02-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

ZonMW

External identifiers

EU CT number

2023-507481-43-00

ClinicalTrials.gov

NCT06118710

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

The primary objective of this study is to evaluate the incidence of clinically relevant HSRs (grade ≥3 as per Common Terminology Criteria for Adverse Events; CTCAE version 5.0) during paclitaxel-based chemotherapy with a standard of care premedication regimen with dexamethasone compared to an experimental premedication regimen without dexamethasone.

Secondary objectives 5

1. To determine the incidence and severity of HSRs (any grade) during paclitaxel-based chemotherapy with a local standard of care premedication regimen with dexamethasone compared to an experimental premedication regimen without dexamethasone.
2. To determine the number of paclitaxel administrations and cumulative dose until the first HSR occurrence (any grade).
3. To determine the effect of dexamethasone omission on the patient’s quality of life.
4. To determine the incidence and severity of adverse events related to dexamethasone.
5. To determine the cost-effectiveness of the premedication regimens with and without dexamethasone from a healthcare and societal perspective.

Conditions and MedDRA coding

Solid tumors

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age ≥18 years
2. Diagnosis of a solid tumor with planned treatment with paclitaxel-based chemotherapy for any indication and with any dose.
3. Mastery of Dutch language
4. Able and willing to give written informed consent.

Exclusion criteria 6

1. Prior treatment with a paclitaxel-based regimen;
2. 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);
3. Known hypersensitivity to paclitaxel, carboplatin, cetirizine, or excipients (e.g., benzyl alcohol);
4. Concomitant use of any systemic corticosteroid for any indication other than paclitaxel premedication;
5. Women with confirmed and ongoing pregnancy;
6. Already participating in an exercise trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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).

Secondary endpoints 7

1. The incidence of the HSRs (all grades) as defined by (CTCAE v.5.0);
2. The severity (grades) of all HSRs as defined by (CTCAE v.5.0);
3. The percentage (%) of patients that can be rechallenged (according to standard of care procedures) after the occurrence of an HSR with or without dexamethasone;
4. The number of paclitaxel administrations and cumulative dose (mg) until the first HSR occurrence.
5. The incidence and severity of adverse events related to dexamethasone measured through the validated Dexamethasone Symptom Questionnaire (DSQ)21;
6. 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);
7. The total cost of treatment of both premedication regimens from a healthcare and societal perspective.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Sponsor organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Address

Dr. Molewaterplein 40

City

Rotterdam

Postcode

3015 GD

Country

Netherlands

Scientific contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Department of Hospital Pharmacy

Public contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Stijn Koolen

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications