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New treatment option for Head and Neck Cancer
Official title Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer
ClinicalTrials.gov ID: NCT04178174
What this study is testing
- What it's testing
- This is a randomized clinical trial comparing the outcomes of short-course chemoradiation consisting in stereotactic boost to the gross tumor and de-esclalated chemoradiation to the elective neck in human papilloma associated oropharynx cancer vs. the current standard 7-week course chemoradiation.
- Phase 3: a large, late-stage study
- 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 years
- Ability to provide written informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx.
- Positive for HPV by p16 immunohistochemistry (IHC) or HPV in-situ hybridization (ISH)
You likely can't join if
- Clinical N3 classification, as per AJCC 8th edition
- Clinically overt extranodal extension (ENE). As per AJCC 8th edition, clinically overt ENE is defined as invasion of the skin, infiltration of...
- Previous irradiation of the head and neck region
- Previous surgery of the HNC region (except for incisional or excisional biopsies)
- Pregnancy or breastfeeding
- Connective tissue disease
See the full eligibility criteria
- Age ≥18 years
- Ability to provide written informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx.
- Positive for HPV by p16 immunohistochemistry (IHC) or HPV in-situ hybridization (ISH)
- Clinical stage T1-3, N1 M0 (Stage I-II) as per AJCC 8th edition.
- Primary tumor \< 30 cc
- Planned for curative chemoradiation
- For females of child-bearing age, a negative pregnancy test
- Clinical N3 classification, as per AJCC 8th edition
- Clinically overt extranodal extension (ENE). As per AJCC 8th edition, clinically overt ENE is defined as invasion of the skin, infiltration of musculature/fixation to adjacent structures on clinical examination, cranial...
- Previous irradiation of the head and neck region
- Previous surgery of the HNC region (except for incisional or excisional biopsies)
- Pregnancy or breastfeeding
- Connective tissue disease
- Any medical condition that could, in the opinion of the investigator, prevent follow-up after radiotherapy.
- Non-Cisplatin concurrent chemotherapy
- Prior induction chemotherapy
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
- Montreal, 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 London, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.