Phase 2 Head and Neck Cancer Trial, Recruiting NCT05800574 Sponsor: Fox Chase Cancer Center Condition: Head and Neck Cancer
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Phase 2 Head and Neck Cancer Trial, Recruiting

NCT05800574
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 who have been diagnosed with squamous cell carcinoma (a type of cancer) of the oropharynx (the middle part of the throat, including the back of the mouth and base of tongue), confirmed by a tissue test
  • People whose treatment plan requires radiation to both sides of the neck, based on current medical guidelines, and who meet specific lymph node staging criteria (confirm with trial site for details on staging categories)
  • People whose tumour comes close to, but does not cross, the midline (centre line) of the throat, as confirmed by scans or a specialist doctor
  • People who have had a CT scan with contrast dye and/or an MRI with contrast dye within the past 56 days, showing no cancer spread to lymph nodes on both sides of the neck
  • People who have had a PET/CT scan within the past 28 days, showing no cancer spread to lymph nodes on both sides of the neck
  • People whose tumour tissue has tested positive for a protein called p16, with moderate to strong staining in at least 70% of the cells tested
  • People who are able to provide their smoking history before joining the trial
  • People whose cancer can be measured using standard imaging measurement guidelines (called RECIST 1.1)
  • People with a general health and activity level rated at 0 or 1 on a standard scale (meaning fully active or able to carry out light activity), assessed within the past 56 days
  • People aged 18 or older
  • People with adequate blood cell counts, kidney function, and liver function, confirmed by blood tests within the past 14 days

Who may not be able to join:

  • People whose tumour crosses the midline of the throat, regardless of its size or stage
  • People who have cancer spread to lymph nodes on both sides of the neck (called bilateral neck adenopathy)
  • People whose primary tumour site was completely surgically removed during a diagnostic procedure before imaging or physical examination by the registering doctor
  • People whose cancer has tested negative for the p16 protein
  • People with clear clinical or scan evidence that the cancer has spread to distant parts of the body, or to lymph nodes below the collarbone
  • People who have previously received systemic treatment (such as chemotherapy or immunotherapy) for this cancer
  • People who have previously had head or neck surgery involving the neck area, including surgical removal of a lymph node for biopsy
  • People who have previously had radiation therapy to the head or neck in a way that would overlap with the areas to be treated in this trial
  • People with a known allergic reaction to a substance called Technetium-99m-tilmanocept, which is used in a type of imaging scan in this trial
  • People with other serious uncontrolled health conditions, including other active cancers, active infections, unstable heart conditions, certain heart rhythm problems, or mental health or personal circumstances that may make it difficult to follow the trial requirements
  • People who are pregnant or breastfeeding

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 20 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: Thomas Galloway, MD, Fox Chase Cancer Center

Phone: 2678388380

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
Fox Chase Cancer Center
Registry
ClinicalTrials.gov
Start date
14 March 2023
Est. completion
23 September 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of patients that develop cancer on the contra-lateral side of the neck within 12 months of completion of radiation treatment

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: 20 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