Phase 2 Head and Neck Cancer Trial, Recruiting NCT05541016 Sponsor: Mayo Clinic Condition: Head and Neck Cancer
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Phase 2 Head and Neck Cancer Trial, Recruiting

NCT05541016
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older
  • People who have been diagnosed with, or are suspected to have, a type of cancer called squamous cell carcinoma that started in the back of the throat (oropharynx)
  • People whose treatment plan involves either surgery to remove the tumour through the mouth plus removal of lymph nodes in the neck, or a combination of radiation therapy and the chemotherapy drug cisplatin — and who are medically suitable for cisplatin even if another drug is used due to supply issues
  • People who have had standard scans (chest CT or PET/CT) within the past 16 weeks showing no spread of cancer to distant parts of the body
  • People who are generally well and able to carry out normal daily activities with little or no limitation (confirm with trial site for exact fitness level required)
  • Women who could become pregnant must have a negative pregnancy test within 7 days before joining
  • People who are able to fill in questionnaires on their own or with help
  • People who are willing to return to the enrolling hospital for follow-up appointments during the study
  • People who are willing to provide blood samples for research, including samples sent for a specific test called NavDx

Who may not be able to join:

  • Women who are pregnant or currently breastfeeding
  • People of childbearing potential who are not willing to use adequate contraception during the study
  • People with serious ongoing illnesses or other severe health conditions that, in the doctor's judgement, would make participation unsafe or affect the reliability of the study results
  • People with a weakened immune system, or people known to be HIV positive
  • People with uncontrolled health problems such as an active infection, heart failure, unstable chest pain, irregular heartbeat, or mental health or social circumstances that would make it difficult to follow the study requirements
  • People currently taking part in another clinical trial for a treatment targeting their cancer
  • People who have had another cancer within the past 5 years — with exceptions for certain skin cancers, early-stage cervical cancer, prostate cancer, or localised uterine cancer, provided they are not currently receiving treatment for that cancer (confirm with trial site)
  • People who have previously had radiation therapy to the area of the body affected by this cancer
  • People who have received chemotherapy within the last 5 years
  • People for whom radiation therapy is not considered safe by their treating medical team
  • People with a known allergy to the drug docetaxel
  • People taking medications that could interfere with the study treatment, such as certain drugs that affect how the body processes chemotherapy (confirm with trial site)
  • People with significant pre-existing hearing loss or nerve damage that would, in the doctor's opinion, make cisplatin chemotherapy unsafe
  • People whose tumour has been classified as cT4 (a more advanced stage of local tumour growth — confirm with trial site)
  • People found after surgery to have no intermediate or high risk features and low-risk disease will be removed from the study and managed under standard care
  • People whose cancer tests negative for both HPV and p16 will be removed from the study
  • All surgery and chemotherapy must be carried out at the hospital enrolling the patient into the trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: David M, Routman, M.D., Mayo Clinic in Rochester

Phone: 855-776-0015

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
21 February 2023
Est. completion
1 August 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Progression-free survival (PFS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov