Phase 2 Head and Neck Cancer Trial, Recruiting NCT06477692 Sponsor: University of Texas Southwestern Medical Center Condition: Head and Neck Cancer
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Phase 2 Head and Neck Cancer Trial, Recruiting

NCT06477692
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:

  • You have been diagnosed with a confirmed squamous cell carcinoma (a type of cancer) located in the oropharynx (back of the throat/tonsils/base of tongue), larynx (voice box), or hypopharynx (lower throat) — the cancer must have a known starting location.
  • Your cancer can be seen or measured through a physical exam or imaging scans at the main tumor site and/or in nearby lymph nodes.
  • You may have had a small diagnostic lymph node removal (up to 2 nodes) or a limited surgical procedure to remove a small tonsil or base of tongue cancer.
  • Your cancer is classified as Stage I through IVB (except Stage I or II glottic/voice box cancer, which is not eligible).
  • You are 18 years of age or older.
  • You are well enough to carry out most daily activities, with only mild limitations at most (confirm with trial site for exact fitness level required).
  • You are willing and able to use reliable birth control (or abstain from sex) during treatment and for 90 days after — this applies to all men and to women who could become pregnant; if you become pregnant during the study, you must inform your doctor right away.
  • Women who have not had a hysterectomy, removal of both ovaries, or natural menopause lasting at least 12 consecutive months are considered able to become pregnant and must follow the birth control requirement above.
  • You are able to have a CT scan of the neck and/or an MRI of the neck, plus a PET-CT scan.
  • You are able to understand the study and are willing to sign a consent form agreeing to take part.

Who may not be able to join:

  • Your cancer has spread to distant parts of the body (metastasis).
  • You are unable to have a CT scan with contrast dye or a planning CT scan with contrast dye.
  • You are unable to have a PET-CT scan.
  • Your cancer is Stage I or II glottic (voice box) cancer.
  • Your entire tumor and all affected lymph nodes have already been completely surgically removed.
  • You have another active cancer (other than certain low-risk prostate cancers or well-differentiated thyroid cancer) occurring at the same time outside the throat areas covered by this trial.
  • You have had a previous cancer (other than certain skin cancers) within the last 3 years.
  • You have previously had chemotherapy treatment for this specific cancer (prior chemotherapy for a different, past cancer may be acceptable).
  • You have previously had radiation therapy in the same area of the body in a way that would overlap with radiation used in this trial.
  • You are currently taking part in another clinical trial using an experimental treatment.
  • You have had a serious allergic reaction to medications similar to those used in this trial (confirm with trial site).
  • You have a serious uncontrolled illness such as an active infection, heart failure, unstable chest pain, irregular heartbeat, or a mental health or personal situation that the study doctors feel would make it difficult to safely take part.
  • You have a history of severe immune system problems, including HIV, or have had an organ transplant or stem cell transplant.

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 21 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 Sher, MD, University of Texas Southwestern Medical Center

Phone: 214-645-8525

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
Registry
ClinicalTrials.gov
Start date
14 November 2024
Est. completion
1 July 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

The probability at two years: SEVR in INRT versus ENI patients

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: 21 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