Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer
NCT ID: NCT04178174
Last Updated: 2025-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
360 participants
INTERVENTIONAL
2020-02-23
2029-12-31
Brief Summary
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Detailed Description
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Stereotactic ablative radiotherapy (SABR) allows for ultra-precise delivery of ablative radiation dose over a small number of fractions, by combining sharp dose gradients with use of optimal image guidance. The increased conformity and reduced margins used in SABR can substantially reduce the dose to surrounding organs at risk and could therefore reduce toxicity. In addition, previous work has shown that an elective dose of 40 Gy in 2 Gy per fraction, in conjunction with chemotherapy, is sufficient for microscopic sterilisation of cancer cells and can translate into a reduction of toxicities.
The goal of this trial is to compare the efficacy and safety of short-course chemoradiation consisting in stereotactic boost to the gross tumor of 14 Gy in 2 fractions followed by de-esclalated chemoradiation (40 Gy in 20 fractions and concurrent 2 cycles of Cisplatin 100mg/m2) in human papilloma associated oropharynx cancer vs. the current standard 7-week course chemoradiation (70 Gy in 33 fractions with 2-3 cycles of Cisplatin 100mg/m2).
This is an open label randomized phase III non inferiority trial. Patients will be randomized using a 1:1 ratio between the standard and the experimental arm and will be stratified by tumor stage and use of concurrent chemotherapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SABR boost and de-escalated chemoradiation
SABR boost of 14 Gy in 2 fractions to the GTV, immediately followed by de-escalated chemoradiation. De-escalated chemoradiation will consist in 40 Gy in 20 fractions with concurrent high dose Cisplatin (3-weekly, 100 mg/m2) for 2 cycles, aiming for a cumulative dose of 200 mg/m2.
SABR boost and de-escalated chemoradiation
Stereotactic body radiotherapy boost to the gross tumor volume to a dose of 14 Gy in 2 fractions, followed by cisplatin-based chemoradiation to a dose of 40 Gy in 20 fractions
Standard chemoradiation
The standard arm will consist of conventionally radiation to a dose of 70 Gy in 33 fractions concurrently with high dose Cisplatin (3-weekly, 100 mg/m2) for 2-3 cycles, aiming for a cumulative dose of ≥ 200 mg/m2.
Standard chemoradiation
Standard Cisplatin-based chemoradiation to a dose of 70 Gy in 33 fractions
Interventions
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SABR boost and de-escalated chemoradiation
Stereotactic body radiotherapy boost to the gross tumor volume to a dose of 14 Gy in 2 fractions, followed by cisplatin-based chemoradiation to a dose of 40 Gy in 20 fractions
Standard chemoradiation
Standard Cisplatin-based chemoradiation to a dose of 70 Gy in 33 fractions
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Jewish General Hospital
OTHER
Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Responsible Party
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Houda Bahig
Radiation Oncologist
Principal Investigators
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Houda Bahig, MD PhD
Role: STUDY_CHAIR
Centre hospitalier de l'Université de Montréal (CHUM)
Phuc-Felix Nguyen-Tan, MD
Role: STUDY_CHAIR
Centre hospitalier de l'Université de Montréal (CHUM)
David Palma, MD PhD
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Jack Phan, MD PhD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Khalil Sultanem, MD
Role: PRINCIPAL_INVESTIGATOR
Montreal Jewish General Hospital
Locations
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London Health Sciences Center
London, Ontario, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHORT-OPC
Identifier Type: -
Identifier Source: org_study_id
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