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| Name | Class |
|---|---|
| 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 |
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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.
Concurrent platinum-based chemoradiation remains the standard of care in locally advanced head and neck cancer. The current standard radiation regimen consists in a 7-week course of conventionally fractionated radiotherapy to the gross tumor volume (GTV), along with bilateral prophylactic neck irradiation to an elective dose of ~ 50 Gy in 2 Gy per fraction. In addition to being cumbersome, the current protracted daily radiation course is associated with high rates of acute and late toxicities and significant deterioration of patients' quality of life. In the light of the remarkably improved prognosis of the distinct subgroup of HPV-OPC, there is growing interest for treatment de-intensification strategies in contemporaneous OPC cohorts.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SABR boost and de-escalated chemoradiation | Experimental | 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. |
|
| Standard chemoradiation | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SABR boost and de-escalated chemoradiation | Radiation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Patient alive with no local, regional or distant recurrence at 2 years after the end of chemoradiation | 2 years after the end of chemoradiation |
| Measure | Description | Time Frame |
|---|---|---|
| Subacute toxicity | Rate of grade ≥ 3 subacute toxicity | Between 2 and 6 months after the end of chemoradiation |
| Acute toxicity | Rate of grade ≥ 3 acute toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diane Trudel | Contact | 514-890-8254 | diane.dt.chum@ssss.gouv.qc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Houda Bahig, MD PhD | Centre hospitalier de l'Université de Montréal (CHUM) | Study Chair |
| Phuc-Felix Nguyen-Tan, MD | Centre hospitalier de l'Université de Montréal (CHUM) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Center | Recruiting | London | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42032732 | Derived | Giguere P, Bahig H, Westra S, Roberge D, Bourque JM, Masucci GL, Nkurunziza ES, Freire V, Belliveau C, Duplan D, Vigneault E, Wong P, Lang P, Menard C. Platform for the Evaluation of innovations in Radiation oncology through registry-based conduct of multi-centric pragmatic randomized trials: PERa implementation. Trials. 2026 Apr 24;27(1):437. doi: 10.1186/s13063-026-09709-0. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
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| Standard chemoradiation | Radiation | Standard Cisplatin-based chemoradiation to a dose of 70 Gy in 33 fractions |
|
| Less than 2 months after the end of chemoradiation |
| Late toxicity | Rate of grade ≥ 3 late toxicity | Between 6 months and 5-years after the end of chemoradiation |
| OS | Overall survival | At 2- and 5-years after the end of chemoradiation |
| locoregional control | Patient alive with locoregional control | At 2- and 5-years after the end of chemoradiation |
| Head and neck symptom burden | Patient-reported head and neck symptom burden as measured by the MD Anderson Symptom Inventory Head and Neck Cancer Module. The core and head and neck cancer specific symptoms are rated on a 0-10 scale to indicate the presence and severity of the symptoms. Lower scores represent better functioning and quality of life. | At baseline, and 1-, 3-, 6-, 12- months post-treatment, and yearly from years 2-5 after the end of chemoradiation |
| Dysphagia | Patient-reported dysphagia as measured by the MD Anderson Dysphagia Index. Overall score ranges from 0 to 100, with higher score representing better functioning and quality of life. | At baseline, and 1-, 3-, 6-, 12- months post-treatment, and yearly from years 2-5 after the end of chemoradiation |
| Time from treatment start to return to work | Time from first day of treatment start to first day of return to work. | Measured in days and reported at 2-years post-treatment |
| David Palma, MD PhD |
| London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Principal Investigator |
| Jack Phan, MD PhD | M.D. Anderson Cancer Center | Principal Investigator |
| Khalil Sultanem, MD | Montreal Jewish General Hospital | Principal Investigator |
| Centre Hospitalier de l'Université de Montréal | Recruiting | Montreal | Quebec | H2X 1R6 | Canada |
|
| D010608 |
| Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |