Overview
Sponsor-declared trial summary
Locally advanced head and neck squamous cell carcinoma
To investigate if the use of weekly low dose cisplatin increases compliance to the planned chemotherapy scheme in LA-HNSCC patients with low SMM to a level of compliance to three-weekly high dose cisplatin of patients without low SMM.
Key facts
- Sponsor
- Universitair Medisch Centrum Utrecht
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Jan 2022 → ongoing
- Decision date (initial)
- 2024-11-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- ZonMw
External identifiers
- EU CT number
- 2024-514919-10-00
- EudraCT number
- 2021-002634-16
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To investigate if the use of weekly low dose cisplatin increases compliance to the planned chemotherapy scheme in LA-HNSCC patients with low SMM to a level of compliance to three-weekly high dose cisplatin of patients without low SMM.
Conditions and MedDRA coding
Locally advanced head and neck squamous cell carcinoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - considered, eligible and planned for primary cisplatin CRT by treating physician; - eighteen years of age or older; - sufficient understanding of Dutch and medical consequences to give informed consent.
Exclusion criteria 1
- - mentally disabled or patients with significantly altered mental status that would prohibit understanding and giving informed consent; - a history of bilateral lymph node dissection in the neck and no available (PET-)CT scan of the third lumbar vertebra; - an absolute contraindication for cisplatin as defined by the treating physician, including relevant pre-existing kidney insufficiency, clinically apparent vascular disease (for example claudicatio intermittens), clinically relevant perceptive deafness, serious neuropathy and poor performance score;
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary outcome parameter is compliance (non CDLT) rate to the proposed cisplatin scheme. Compliance to chemotherapy is defined as the absence of CDLT. CDLT is defined as any toxicity resulting in a cisplatin dose-reduction of ≥50%, a postponement of treatment of ≥4 days or a definite termination of cisplatin after the first or second cycle of therapy.
Secondary endpoints 1
- Secondary outcome parameters are adverse events/toxicity, cumulative cisplatin dose, time to recurrence, 2-year overall survival, costs, quality of life and patient's preference. The main oncological outcome parameters are time to recurrence and survival. Clinically relevant treatment related toxicity parameters, including specific toxicity that results in significant (grade 3 or 4) toxicity, treatment de-escalation or termination, will be recorded by the treating medical oncologist.Toxicity wi
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Cisplatin Accord Healthcare 1 mg/ml concentraat voor oplossing voor infusie
PRD415242 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 40 mg/m2 milligram(s)/square meter
- Max total dose
- 280 mg/m2 milligram(s)/square meter
- Max treatment duration
- 7 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- BE375952
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Utrecht
- Sponsor organisation
- Universitair Medisch Centrum Utrecht
- Address
- Heidelberglaan 100
- City
- Utrecht
- Postcode
- 3584 CX
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- Remco de Bree
Public contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- Remco de Bree
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 160 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2022-01-24 | 2022-01-24 | 2025-06-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-514919-10-00 for publication | 8.0 |
| Recruitment arrangements (for publication) | K1_blank document | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults location AUMC for publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults location AVL for publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults location LUMC for publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults location NWZ for publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults location UMCU low SMM for publication | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults location UMCU low SMM not for publication | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults location UMCU normal SMM for publication | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults location UMCU normal SMM not for publication | 5.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Cisplatin | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-09 | Netherlands | Acceptable 2024-11-11
|
2024-11-11 |