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2024-517832-23-00Active, not recruitingPhase 2

NaDeJ (National Deescalation Study One)

Prospective, multicentre phase II study of de-escalation of primary chemoradiotherapy of squamous cell carcinoma of oropharynx (OPC) associated with human papilloma virus (HPV)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Nov 2024

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Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
100 (estimated)
First submitted
11 Oct 2024
Start date
9 Jan 2020
Lead sponsor
Vychodoslovensky Onkologicky Ustav a.s.
EU CT number
2024-517832-23-00
EudraCT number
2019-003058-10

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 100
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous allergic reaction to cisplatin
  • Previous radiotherapy in the head and neck area to overlap the irradiated volume

Other illness

  • 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

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Vychodoslovensky Onkologicky Ustav a.s.KošiceSlovakiaActive, not recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.