Head and Neck Squamous Cell Carcinoma study: Traditional Palliation
Official title 3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial
ClinicalTrials.gov ID: NCT05674396
What this study is testing
- What it's testing
- The study wants to see if stereotactic body radiation therapy can safely give a strong dose of radiation in fewer sessions than usual.
- Who it's for
- Adults with head and neck squamous cell carcinoma who can receive radiation therapy.
- What's involved
- Participants will receive SBRT treatment, which involves a few targeted radiation sessions and related medical visits.
- Time commitment
- The trial lasts a few weeks, with several scheduled visits for treatment and follow‑up.
- Phase 2: a mid-size study of how well it works
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Ineligible for curative intent treatment after multidisciplinary evaluation (including evaluation by radiation oncologist and surgeon followed by...
You likely can't join if
- 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...
- Documentation of smoking history
- Contrast-enhanced CT of the neck and chest or
- MRI of the neck with CT of the chest or
See the full eligibility 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
- 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.
- Documentation of smoking history
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.