Advanced radiation treatment for head and neck cancer palliation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of stereotactic body radiation therapy (SBRT) in providing palliative care for patients with head and neck squamous cell carcinoma who are not eligible for curative treatment. The study compares local progression-free survival, pain response, symptom burden, toxicity, local control, and overall survival between SBRT and traditional radiation methods. Participants will receive either SBRT or standard palliative radiation, with their outcomes monitored over time to assess the benefits of the advanced technique.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 or older
* Willing to provide informed consent
* Histologically confirmed squamous cell carcinoma
* Primary tumor site in the head and neck (includes oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, salivary gland, and cutaneous subsites as well as tumors of unknown primary site)
* Ineligible for curative intent treatment after multidisciplinary evaluation (including evaluation by radiation oncologist and surgeon followed by presentation at multidisciplinary tumor board prior to randomization)
* Prior therapy including radiation, surgery, or systemic therapy is permitted unless further radiation is deemed inappropriate by the enrolling physician
* Metastatic disease is permitted

Exclusion Criteria:

* Contraindications to radiotherapy
* Pregnant or lactating women

5.0 PRE-TREATMENT EVALUATION

* History and physical examination including laryngopharyngoscopy by a radiation oncologist and/or head and neck surgeon within 8 weeks prior to randomization.

  o Clinical examination will include a detailed description of disease target including measurement where feasible to facilitate response assessment
* Documentation of smoking history
* Staging imaging within 12 weeks prior to randomization:

  * Contrast-enhanced CT of the neck and chest or
  * MRI of the neck with CT of the chest or
  * Whole body PET/CT
* Histological confirmation of squamous cell carcinoma
* Pregnancy test for women of child-bearing age, within 2 weeks prior to randomization
* Assessment of all baseline symptoms, using CTCAE version 5.0 within 2 weeks prior to randomization.
* Assessment of baseline pain score (NRS) and analgesic use (non-opioid and opioid)
* Completion of QOL scoring within 2 weeks of randomization
* Informed consents must be obtained prior to any study specific activities

Where it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Jay Reddy, MD,PHD — M.D. Anderson Cancer Center
• Study coordinator: Jay Reddy, MD,PHD
• Email: jreddy@mdanderson.org
• Phone: (832) 750-2924

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Online Sharing for Head & Neck Cancer Support

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• Telisotuzumab Adizutecan with Pembrolizumab as first-line treatment for recurrent or metastatic head and neck cancer

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• Mild heat therapy added to standard treatment for locally advanced head and neck cancer

  This early-stage trial tests whether mild hyperthermia can be safely added to standard radiotherapy with or without chemotherapy for locally advanced head and neck cancer.

  Recruiting Phase 1 Erasmus Medical Center · Rotterdam, South Holland · NCT07690618

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.