Title |
Stereotactic Boost and SHOrt-course Radiation Therapy for HPV-associated OroPharynx Cancer Trial: A Randomized Multicentric Phase II Trial |
Protocole ID |
SHORT-OPC |
ClinicalTrials.gov ID |
NCT04178174 |
Cancer Type(s) |
Head and Neck |
Phase |
Phase II |
Stage |
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Study Type |
Clinical |
Drug |
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Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
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City |
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Principal Investigator |
Dr. Houda Bahig
|
Coordinator |
Mom Phat
514-890-8000 poste 11171
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Status |
Recruiting |
Activation Date |
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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
|
Exclusion Criteria |
- Previous irradiation of the head and neck (HNC) 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
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