NCT04178174 Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer
| NCT ID | NCT04178174 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2020-02-23 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 360 participants in total. It began in 2020-02-23 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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 Exclusion Criteria: * 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 nerve, brachial plexus, sympathetic trunk or phrenic nerve invasion with dysfunction). * 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
Contact & Investigator
Houda Bahig, MD PhD
STUDY CHAIR
Centre hospitalier de l'Université de Montréal (CHUM)
Frequently Asked Questions
Who can join the NCT04178174 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04178174 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 360 participants.
Is NCT04178174 currently recruiting?
Yes, NCT04178174 is actively recruiting participants. Contact the research team at diane.dt.chum@ssss.gouv.qc.ca for enrollment information.
Where is the NCT04178174 trial being conducted?
This trial is being conducted at London, Canada, Montreal, Canada.
Who is sponsoring the NCT04178174 clinical trial?
NCT04178174 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The principal investigator is Houda Bahig, MD PhD at Centre hospitalier de l'Université de Montréal (CHUM). The trial plans to enroll 360 participants.
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