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Compares treatment options for Advanced Head and Neck Cancer
Official title Palliative Steroeotactic Body Radiotherapy vs Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer
ClinicalTrials.gov ID: NCT06641791
What this study is testing
- What it's testing
- This study is being done to answer the following question: Does stereotactic body radiation therapy (SBRT) provide better cancer control compared to standard radiation therapy (RT) for those with advanced head and neck cancer?
- Phase 3: a large, late-stage study
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
- Histologically confirmed mucosal squamous cell carcinoma (SCC) of the head and neck arising from at least one of the following sites...
- Stages TX or T0-T4/N0-N3
- Must be considered unfit for curative intent RT as determined by the treating oncologist(s)
- Geriatric 8 score \<14
- Patient must be ≥18 years of age
You likely can't join if
- Patients with nasopharyngeal carcinoma.
- Prior systemic therapy (including immunotherapy).
- Prior radiotherapy to the head and neck excluding superficial radiotherapy for head and neck skin cancer that does not overlap with current protocol...
- Prior head and neck cancer excluding skin cancer.
- Patients with tumour locations/at risk of SBRT toxicity, including glottic/subglottic larynx, T4 hypopharynx, post-cricoid, cervical esophagus...
- \> 2 nodal levels (Level 1a/b not counted); retropharyngeal lymph nodes (where the closest edge is \< 2cm from the closest edge of CTV (primary or...
See the full eligibility criteria
- Histologically confirmed mucosal squamous cell carcinoma (SCC) of the head and neck arising from at least one of the following sites: oro/hypopharynx, oral cavity, supraglottic larynx, maxillary sinus, nasal cavity, or...
- Stages TX or T0-T4/N0-N3
- Must be considered unfit for curative intent RT as determined by the treating oncologist(s)
- Geriatric 8 score \<14
- Patient must be ≥18 years of age
- Staging CT or MRI of the head and neck within 8 weeks prior to randomization
- Chest CT or x-ray. PET CT is permitted if CT is of diagnostic quality.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
- Participants of childbearing potential must have agreed to use a highly effective contraceptive method during protocol therapy.
- Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational treatment are eligible for this trial.
- Patients with nasopharyngeal carcinoma.
- Prior systemic therapy (including immunotherapy).
- Prior radiotherapy to the head and neck excluding superficial radiotherapy for head and neck skin cancer that does not overlap with current protocol treatment.
- Prior head and neck cancer excluding skin cancer.
- Patients with tumour locations/at risk of SBRT toxicity, including glottic/subglottic larynx, T4 hypopharynx, post-cricoid, cervical esophagus, circumferential pharyngeal involvement, extension/proximity to brain/optic...
- \> 2 nodal levels (Level 1a/b not counted); retropharyngeal lymph nodes (where the closest edge is \< 2cm from the closest edge of CTV (primary or nodal) will not be considered as a different level). Note: a single...
- Gross tumour poorly visualized on CT/MRI.
- Definitive radiological or clinically evident distant metastases.
- Scleroderma/CREST syndrome.
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- Winnipeg, Manitoba, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
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 - 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?
Study sites include Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.