BridgeMD
NaDeJ (National Deescalation Study One)
EU CTIS ID: 2024-517832-23-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Tumor in the oral cavity or in nasopharynx or in the hypopharynx or larynx if the p16 is also positive
- 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
- Tumor of unknown origin (p16 positivity too)
See the full eligibility criteria
- 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
- Tumor in the oral cavity or in nasopharynx or in the hypopharynx or larynx if the p16 is also positive
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.