Authorised Therapeutic confirmatory (Phase III) Human papillomavirus (HPV)-positive oropharyngeal cancer

Post-operative adjuvant treatment for HPV-positive tumours

Q: 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.

Q: 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.

Q: 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.

Q: Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Q: Where is this trial taking place?

Study sites include United Kingdom; United States; Australia. Enter your location above to see the nearest site and check your eligibility.

EU CTIS ID: 2024-516673-68-00

What this study is testing

1. To demonstrate if swallowing function can be improved and toxicities reduced following transoral surgery for HPV-positive oropharyngeal cancer, by reducing the intensity of adjuvant treatment protocols. 2. To demonstrate the non-inferiority of reducing the intensity of adjuvant treatment protocols in terms of overall survival

Therapeutic confirmatory (Phase III)

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

Histologically confirmed or suspected squamous cell carcinoma of the oropharynx.
Group B : Fit to undergo radiotherapy.
Group B : HPV positive by both P16 and either High Risk HPV In-Situ Hybridization (ISH) or validated Polymerase Chain Reaction (PCR) technique
Group C : Fit for, and able to potentially benefit from chemoRT, as decided by an MDT.
Group C : Willing to be treated with chemotherapy
Group C : HPV positive by both P16 and either High Risk HPV In-Situ Hybridization (ISH) or validated Polymerase Chain Reaction (PCR) technique

You likely can't join if

Known HPV negative squamous cell carcinomas of the head and neck: A negative result for p16 Immunohistochemistry automatically excludes a patient from the trial. If initial p16 testing is positive but High-Risk HPV (HR HPV) In-Situ Hybridization (ISH) / Polymerase Chain Reaction (PCR) does not demonstrate the presence of HR HPV DNA, the patient will also be excluded. Patients who are p16 positive may complete swallowing assessments, excluding videofluoroscopy, and surgery whilst HR HPV DNA status is being determined (with recourse to central concordance testing, if appropriate, for UK centres). HPV positivity, as determined by p16 and the demonstration of HR HPV DNA is essential before patients undergo videofluoroscopy or randomisation.
Persons deprived of their liberty or under protective custody or guardianship (applicable for France only)
Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons (applicable for France only).
Group B : pN2c or pN3 as per UICC/AJCC TNM 7th edition.
Group C : Myelosuppression
Group C : Pre-existing renal impairment (GFR < 50ml/min).

See the full eligibility criteria

Who can join

Histologically confirmed or suspected squamous cell carcinoma of the oropharynx.
Group B : Fit to undergo radiotherapy.
Group B : HPV positive by both P16 and either High Risk HPV In-Situ Hybridization (ISH) or validated Polymerase Chain Reaction (PCR) technique
Group C : Fit for, and able to potentially benefit from chemoRT, as decided by an MDT.
Group C : Willing to be treated with chemotherapy
Group C : HPV positive by both P16 and either High Risk HPV In-Situ Hybridization (ISH) or validated Polymerase Chain Reaction (PCR) technique
Group C : Bone marrow reserve adequate for chemotherapy (i.e. absolute neutrophil count (ANC) ≥ 1.5 x 109/l and platelet count ≥ 100 x 109/l).
Group C : Adequate GFR for Cisplatin chemotherapy, defined as GFR ≥ 50 ml/min.
UICC/AJCC TNM 7th edition stage T1-T3*, N0-N2b (or UICC TNM 8th edition stage T1-T3, N0-N1) disease.
Multidisciplinary team (MDT) decision to treat with primary transoral resection and neck dissection.
Patients considered fit for surgery and adjuvant radiotherapy
Aged 18 or over.
Written informed consent provided (not applicable for France).
Patients must be affiliated to a Social Security System (applicable for France only)
Patient must have signed informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent (applicable for France only).
Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures (applicable for France only).

What rules you out

Known HPV negative squamous cell carcinomas of the head and neck: A negative result for p16 Immunohistochemistry automatically excludes a patient from the trial. If initial p16 testing is positive but High-Risk HPV (HR HPV) In-Situ Hybridization (ISH) / Polymerase Chain Reaction (PCR) does not demonstrate the presence of HR HPV DNA, the patient will also be excluded. Patients who are p16 positive may complete swallowing assessments, excluding videofluoroscopy, and surgery whilst HR HPV DNA status is being determined (with recourse to central concordance testing, if appropriate, for UK centres). HPV positivity, as determined by p16 and the demonstration of HR HPV DNA is essential before patients undergo videofluoroscopy or randomisation.
Persons deprived of their liberty or under protective custody or guardianship (applicable for France only)
Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons (applicable for France only).
Group B : pN2c or pN3 as per UICC/AJCC TNM 7th edition.
Group C : Myelosuppression
Group C : Pre-existing renal impairment (GFR < 50ml/min).
Group C : History of significant cardiac conditions, arteriopathy, or other medical conditions that preclude the use of Cisplatin and IV hydration.
Group C : Clinically significant hearing impairment sufficient to affect daily living (as reported by the patient) and/or pre-existing tinnitus.
Group C : Pre-existing peripheral neuropathy which precludes the use of Cisplatin.
Group C : Hypersensitivity to the active substance or other platinum compounds or to any of the excipients listed in the SPC.
Group C : Dehydrated condition (pre- and post-hydration is required to prevent serious renal dysfunction).
T4 and/or T1-T3 tumours where transoral surgery is considered not feasible.
Group C : pN2c or pN3 as per UICC/AJCC TNM 7th edition.
UICC/AJCC TNM 7th edition N2c-N3 nodal disease (or UICC/AJCC TNM 8th edition N2-N3 nodal disease).
Patients for whom transoral surgery and neck dissection is not considered the primary treatment modality.
Current smokers with clinically staged N2b disease (including smokers up to 6 months before diagnosis), even if HPV-positive. Vaping is permitted and should be considered as non-smoking status.
Any pre-existing medical condition likely to impair swallowing function and/ or a history of pre-existing swallowing dysfunction prior to index oropharyngeal cancer.
Patients with distant metastatic disease as determined by routine pre-operative staging radiological investigations e.g., CT thorax and upper abdomen or PET-CT.
Patients with a history of malignancy in the last 5 years, except basal cell carcinoma of the skin or carcinoma in-situ of the cervix.
Women who are pregnant or breastfeeding and fertile women who will not be using contraception during the trial.

The study team makes the final eligibility decision.

Where it's taking place

United Kingdom
United States
Australia

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.

Where is this trial taking place?

Study sites include United Kingdom; United States; Australia. Enter your location above to see the nearest site and check your eligibility.

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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.