Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
100
Countries
1
Sites
1
Human Papillomavirus oropharyngeal squamous cell carcinoma
Assesment of primary CRT de-escalation effectiveness in achieving two-year local disease control and late toxicity prevalence evaluated by CTC AE v.4 and PRO CTC v 4.
Key facts
- Sponsor
- Vychodoslovensky Onkologicky Ustav a.s.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 9 Jan 2020 → ongoing
- Decision date (initial)
- 2024-11-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-517832-23-00
- EudraCT number
- 2019-003058-10
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Diagnosis, Dose response, Safety
Assesment of primary CRT de-escalation effectiveness in achieving two-year local disease control and late toxicity prevalence evaluated by CTC AE v.4 and PRO CTC v 4.
Secondary objectives 10
- Assessment of relapse-free and overall survival
- Assessment of acute toxicity and compliance with treatment
- Analysis of results according to known prognostic factors including smoking
- Assesment of PRO in terms of quality of life before and after treatment using validated questionnaires
- Assesment of the impact of treatment on sexual life using a validated questionnaire
- Standardization of RT OPC planning in participating centers
- Dosimetric risk analysis of xerostomy and dysphagia
- Central assessment of p16 status and its correlation with a specific test aimed at identifying HPV oncogenes
- Molecular profile and genomic analysis of tumors in non-smokers and smokers
- Assessment of negative predictive value of PETCT after CRT
Conditions and MedDRA coding
Human Papillomavirus oropharyngeal squamous cell carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10081287 | HPV positive oropharyngeal squamous cell carcinoma | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 15
- Oropharyngeal squamous cell carcinoma
- Positivity of p16 by imunohistochemistry
- Clinical stage T1-T2, N1-N2c or T3, N2-N2c, UICC 8th edition without distant metastases
- The lifetime cumulative history of smoking cannot exceed 20 packages / years
- WHO status 0-1
- Age ≥ 18 years
- Both genders
- Hemoglobin ≥ 10 g/l
- Platelets ≥1 00x 10x9/l
- Neutrophils ≥ 1,5 x 10x9/l
- Adequate renal functions enable one-week therapy of cisplatina
- Bilirubin, AST or ALT 3x upper limit of norm
- Negative pregnancy test
- Signed informed consent
- Slovak language
Exclusion criteria 13
- Tumor in the oral cavity or in nasopharynx or in the hypopharynx or larynx if the p16 is also positive
- Tumor of unknown origin (p16 positivity too)
- Simultaneous tumors
- Patients with invasive malignancy (except non-melanoma skin cancer) and a history of tumor diagnosis less than 3 years
- Previous radiotherapy in the head and neck area to overlap the irradiated volume
- Unstable angina or congestive heart failure requiring hospitalization for the last 6 months
- Transmural myocardial infarction last 6 months
- Active infection requiring i.v. antibiotics at the time of registration
- Chronic obstructive bronchoplumonal disease with exacerbation or other respiratory disease requiring hospitalization or postponement of study treatment within 30 days of enrollment
- Hepatic insufficiency with clinical jaundice and impaired coagulation
- Active AIDS disease, but the protocol does not require HIV testing
- Pregnancy
- Previous allergic reaction to cisplatin
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Two-year locoregional control
Secondary endpoints 9
- Primary loco-regional control after initial intervention and CRT
- Overall survival
- Disease-specific survival
- Survival without disease
- Percentage of distant metastases
- Adverse effects
- Influencing QoL
- Reliability and validity of biomarker p16
- Difference in OPC-associated HPV molecular profile in non-smokers and smokers
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP134220 · ATC
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 35 mg/m2 milligram(s)/square meter
- Max total dose
- 210 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vychodoslovensky Onkologicky Ustav a.s.
- Sponsor organisation
- Vychodoslovensky Onkologicky Ustav a.s.
- Address
- Rastislavova 43, Juh Juh
- City
- Kosice
- Postcode
- 040 01
- Country
- Slovakia
Scientific contact point
- Organisation
- Vychodoslovensky Onkologicky Ustav a.s.
- Contact name
- Principal investigator
Public contact point
- Organisation
- Vychodoslovensky Onkologicky Ustav a.s.
- Contact name
- Principal investigator
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Univerzita Pavla Jozefa Safarika V Kosiciach ORG-100040399
|
Kosice - Stare Mesto, Slovakia | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Slovakia | Ongoing, recruitment ended | 100 | 1 |
| 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 |
|---|---|---|---|---|---|
| Slovakia | 2020-01-09 | 2020-01-09 | 2024-11-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protokol_Nadej 2024-517832-23-00 | 2 |
| Protocol (for publication) | D1_Protokol_Nadej 2024-517832-23-00_correct document | 2 |
| Recruitment arrangements (for publication) | NaDeJ_Blank document_Transition | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_cisplatin Accord | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis SK 2024-517832-23-00 | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-11 | Slovakia | Acceptable 2024-10-31
|
2024-11-04 |