NaDeJ (National Deescalation Study One)
Key facts
- Where
- Košice, SzlovákiaSee the site
- Phase
- 2. fázis
Where in Szlovákia
- Vychodoslovensky Onkologicky Ustav a.s.Košice, SzlovákiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vychodoslovensky Onkologicky Ustav a.s.
- Trial code
- EU 2024-517832-23-00
- Record updated
- 2024. november 4.
- Original description
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.Read full original descriptionShow less
Prospective, multicentre phase II study of de-escalation of primary chemoradiotherapy of squamous cell carcinoma of oropharynx (OPC) associated with human papilloma virus (HPV)
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.
Inclusion: Oropharyngeal squamous cell carcinoma; 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; 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.
Exclusion: Previous allergic reaction to cisplatin; Previous radiotherapy in the head and neck area to overlap the irradiated volume; Hepatic insufficiency with clinical jaundice and impaired coagulation; Active AIDS disease, but the protocol does not require HIV testing; Patients with invasive malignancy (except non-melanoma skin cancer) and a history of tumor diagnosis less than 3 years; 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; Tumor in the oral cavity or in nasopharynx or in the hypopharynx or larynx if the p16 is also positive; Pregnancy; Tumor of unknown origin (p16 positivity too); Simultaneous tumors.