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Study on Reducing Treatment Intensity for Patients with HPV-Positive Oropharyngeal Cancer Using Cisplatin and Carboplatin

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Human papillomavirus (HPV)-positive oropharyngeal cancer, a type of throat cancer linked to the HPV virus. The study aims to explore the effects of reducing the intensity of additional treatments after surgery, specifically looking at how this might improve swallowing function and reduce side effects. The treatments being studied include two chemotherapy drugs, Cisplatin and Carboplatin, which are given through an intravenous infusion, meaning they are administered directly into the bloodstream through a vein.

The purpose of the study is to determine if a less intense treatment approach can maintain the same level of effectiveness in terms of overall survival while improving the quality of life for patients. Participants in the study will undergo surgery to remove the cancer, followed by a reduced intensity of additional treatments. The study will monitor the participants' swallowing abilities and overall health over time to assess the impact of the treatment changes.

Throughout the study, researchers will collect information on the participants' survival rates and any side effects experienced. The goal is to find a balance between effective cancer treatment and minimizing the negative impact on patients' daily lives, particularly focusing on their ability to swallow and overall well-being. This research could lead to improved treatment protocols for individuals with HPV-positive oropharyngeal cancer in the future.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical condition, and readiness for treatment.

    Informed consent is required, ensuring understanding of the study's procedures and requirements.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current health status and suitability for the treatment plan.

    This includes a review of medical history and any necessary laboratory tests.

  3. Step 3

    Surgery

    Transoral surgery is performed to remove the tumor from the oropharynx.

    Neck dissection may also be conducted as part of the surgical procedure.

  4. Step 4

    Adjuvant treatment planning

    Following surgery, a treatment plan is developed to reduce the intensity of additional therapies while maintaining effectiveness.

    The plan aims to improve swallowing function and reduce side effects.

  5. Step 5

    Chemotherapy administration

    Chemotherapy may be administered intravenously using medications such as cisplatin or carboplatin.

    The specific dosage and frequency are determined based on individual health status and treatment goals.

  6. Step 6

    Radiotherapy

    Radiotherapy is provided to target any remaining cancer cells and prevent recurrence.

    The intensity and duration are adjusted to minimize side effects while ensuring treatment effectiveness.

  7. Step 7

    Follow-up assessments

    Regular follow-up assessments are conducted to monitor overall health, swallowing function, and any side effects.

    These assessments include both qualitative and quantitative evaluations of swallowing ability.

  8. Step 8

    Quality of life evaluation

    Quality of life is assessed using specific questionnaires to understand the impact of treatment on daily living.

    This includes evaluating both physical and emotional well-being.

  9. Step 9

    Study completion

    The study is expected to conclude by October 2028, with ongoing monitoring and data collection until that time.

    Final assessments will determine the overall success of the treatment plan in improving survival and quality of life.

Who can join the trial?

14 criteria

  • Must have a confirmed or suspected type of cancer called squamous cell carcinoma in the oropharynx, which is part of the throat.
  • Must be able to undergo radiotherapy, a treatment using radiation to kill cancer cells.
  • Must have a positive test for HPV (Human Papillomavirus) using specific tests called P16 and either High Risk HPV In-Situ Hybridization (ISH) or Polymerase Chain Reaction (PCR).
  • Must be fit for and able to potentially benefit from a combination of chemotherapy and radiotherapy, as decided by a group of healthcare professionals called a multidisciplinary team (MDT).
  • Must be willing to receive chemotherapy, a treatment using drugs to kill cancer cells.
  • Must have enough healthy bone marrow, which is the spongy tissue inside bones, to handle chemotherapy. This is measured by certain blood counts.
  • Must have a good enough GFR (Glomerular Filtration Rate), which measures kidney function, to receive a specific chemotherapy drug called Cisplatin.
  • Must have cancer at a specific stage, according to a system called UICC/AJCC TNM, which describes the size and spread of cancer.
  • Must have a decision from the MDT to treat with surgery that involves removing the tumor through the mouth and possibly removing lymph nodes in the neck.
  • Must be considered fit for surgery and additional radiotherapy after surgery.
  • Must be 18 years old or older.
  • Must provide written informed consent, which means agreeing to participate in the study after understanding all the details. In France, if unable to give written consent, a trusted person can confirm consent in writing.
  • In France, must be part of a Social Security System.
  • In France, must be willing and able to follow the study plan, including attending scheduled visits and undergoing tests and procedures.

Who cannot join the trial?

4 criteria

  • Patients who do not have HPV-positive oropharyngeal cancer cannot participate. This type of cancer is found in the throat and is linked to the human papillomavirus (HPV).
  • Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, but the exact ages are not specified here.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of participants, but the exact group is not detailed here.
  • Patients who are considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent, but the exact group is not specified here.
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Investigated drugs

  • Cisplatin

    is a chemotherapy medication used to treat various types of cancer, including oropharyngeal cancer. In this trial, it is used as part of the adjuvant treatment to help eliminate any remaining cancer cells after surgery.

  • Radiation Therapy

    is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. In this trial, it is used as an adjuvant treatment to target any remaining cancer cells following surgery for HPV-positive oropharyngeal cancer.

What is already known about the treatment

PATHOS Trial Medication – This medication is administered as part of a clinical trial focusing on patients with HPV-positive oropharyngeal cancer. The trial aims to evaluate the effects of reduced intensity adjuvant treatment following transoral surgery. The main therapeutic goal is to improve swallowing function and reduce treatment-related toxicities while maintaining overall survival rates. The medication's mechanism of action and pharmacological classification are not specified, as the trial primarily investigates the treatment protocol's intensity rather than a specific drug. The trial is currently in Phase III, indicating it is in the later stages of clinical testing.

Investigated diseases

Human papillomavirus (HPV)-positive oropharyngeal cancer – This is a type of cancer that occurs in the oropharynx, which is the middle part of the throat, including the back of the tongue, tonsils, and walls of the throat. It is associated with infection by the human papillomavirus (HPV), a common virus that can cause changes in the cells of the oropharynx. The disease often begins with symptoms such as a persistent sore throat, difficulty swallowing, or a lump in the neck. As it progresses, it may lead to more severe swallowing difficulties and changes in voice. The cancer can spread to nearby tissues and lymph nodes, affecting the function of the throat and surrounding areas. Early detection and monitoring are crucial for managing the progression of this disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516673-68-00Protocol codeSPON1610-17Estimated enrolment1 431 patientsSponsorCardiff University

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