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New treatment option for Oropharynx Cancer
Official title Lymphocyte-Sparing And Radio-Immunotherapy in Head and Neck Carcinoma
ClinicalTrials.gov ID: NCT06706401
What this study is testing
What is Vesanoid?
Vesanoid is an investigational medicine, being studied as a potential treatment for oropharynx cancer.
Also referred to as ATRA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of this study is to investigate the effect of ATRA (Vesanoid) and the effect of tailored radiotherapy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- I1. Male or female patients aged ≥ 18 years old at time of inform consent signature. I2. Patients with primary head and neck tumour up to, but not...
- the oropharynx p16-, larynx or hypopharynx : T1/N2a-N2b, T2/N0-N2b, T3/N0-N2b (UICC 8th Ed.), or
- the oropharynx p16+ : T1/N1 (multiple nodes), T2-T3/N0-N1 (UICC 8th Ed.). I3. Patients with lymph node staging assessed by an FDG-PET/CT with no...
- Neutrophils count \> 1.5 × 109 /L
- Platelets count \> 75 × 109 /L
You likely can't join if
- E1. Patient with primary tumor crossing the midline or patients with bilateral primary tumors. E2. Patients with T1-N0 (p16-), T1-N1 (p16-), T1-N0...
- Severe infection within 4 weeks prior to randomisation, including, but not limited to, hospitalization for complications of infection, bacteremia, or...
- Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening),
- Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA at screening,
- HIV infection,
- Active tuberculosis. E11.Patient with any psychological, cognitive, familial, sociological or geographical condition potentially hampering compliance...
See the full eligibility criteria
- I1. Male or female patients aged ≥ 18 years old at time of inform consent signature. I2. Patients with primary head and neck tumour up to, but not crossing the midline, previously untreated with histologically-confirmed...
- the oropharynx p16-, larynx or hypopharynx : T1/N2a-N2b, T2/N0-N2b, T3/N0-N2b (UICC 8th Ed.), or
- the oropharynx p16+ : T1/N1 (multiple nodes), T2-T3/N0-N1 (UICC 8th Ed.). I3. Patients with lymph node staging assessed by an FDG-PET/CT with no contralateral nodal uptake. I4. Patients amenable to treatment with RT or...
- Neutrophils count \> 1.5 × 109 /L
- Platelets count \> 75 × 109 /L
- WBC≥ 3.0 × 109 /L Hepatic function :
- Total Bilirubin \< 1.5 × ULN (except for Gilbert's syndrome which will allow bilirubin ≤ 3 ULN).
- Alanine aminotransferase (ALT) ≤ 2.5 × ULN.
- Aspartate aminotransferase (AST) ≤ 2.5 × ULN.
- Albumin \>3.0g/dL Renal function :
- Serum creatinine \< 1.5 ×ULN. I7. QTcF ≤450ms for men and 470ms for women, from 3 electrocardiograms on screening ECG, within 7 days prior randomisation. I8. Women patients of child-bearing potential are eligible...
- E1. Patient with primary tumor crossing the midline or patients with bilateral primary tumors. E2. Patients with T1-N0 (p16-), T1-N1 (p16-), T1-N0 (p16+), T4 (p16- and p16+), bilateral lymph nodes or nodal disease more...
- Severe infection within 4 weeks prior to randomisation, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia,
- Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening),
- Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA at screening,
- HIV infection,
- Active tuberculosis. E11.Patient with any psychological, cognitive, familial, sociological or geographical condition potentially hampering compliance with the study protocol, completion of patient reported measures and...
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France, France
- Vandœuvre-lès-Nancy, France, France
- Villejuif, France, France
- Angers, France
- Lille, France
- Nice, France
- Paris, France
- Reims, France
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France, France; Vandœuvre-lès-Nancy, France, France; Villejuif, France, France; Angers, France; Lille, France; Nice, France and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.