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The purpose of this study is to find out whether radiotherapy to some of the lymph node areas can be safely omitted to decrease side effects without increasing the risk of the tumour coming back.
The standard or usual treatment for this disease includes radiotherapy or radiotherapy combined with chemotherapy or antibody therapy.
These treatments are highly effective at curing most patients with HPV-related cancer of the oropharynx, but short and long-term side effects from treatment can be significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Other | This is a non-randomized, single-arm study evaluating elective volume-adjusted de-escalation radiotherapy. Patients receive one of two treatment options, based on treating physician discretion. Both options are considered part of a unified treatment strategy and analyzed as a single arm.
Radiotherapy: 70 Gy to the high-risk volume and 56 Gy to the elective volume, delivered in 35 fractions over 7 weeks (5 fractions/week) Cisplatin: Either 100 mg/m² on days 1, 22, and 43 or 40 mg/m² weekly for 7 weeks
Radiotherapy: 70 Gy to the high-risk volume and 56 Gy to the elective volume, delivered in 35 fractions over 6 weeks (6 fractions/week) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation | Radiation | 35 fractions, 5/wk, 7 wks 70Gy/56Gy, or 35 fractions, 6/wk, 6 wks, 70Gy/56Gy, or 35 fractions, 5/wk, 7 wks OR 6/wk, 6 wks 70Gy/56Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival | Event free survival (EFS) is defined as the time from the date of registration to the date of first record of any of the following events:
| 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | For patients who have died, overall survival is calculated in months from the day of registration to date of death. Otherwise, overall survival is censored at the last day the patient is known alive (LKA). The outcome is reported as the proportion of patients who remain alive at 2 years. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Bratman | Princess Margaret Cancer Centre, Toronto, ON | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BCCA - Centre for the North | Prince George | British Columbia | V2M 7E9 | Canada | ||
| BCCA - Vancouver Cancer Centre |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Arm | Elective volume adjusted de-escalation radiotherapy. Option #1 - Radiotherapy 35 fractions, 5/wk, 7 wks 70Gy/56Gy Cisplatin 100mg/m2 on day 1, 22 and 43 or 40mg mg/m2/wk for 7 wks Option #2 - Radiation only-35 fraction, 6/wk, 6wks 70Gy/56Gy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 14, 2020 | Jun 16, 2025 |
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|
| Cisplatin | Drug | 100 mg/m2 on day 1, 22, and 43 or 40 mg/m2 /wk for 7 wks |
|
|
| Local-regional Control |
Local-regional control is defined as the time from the date of registration to the date of any of the following, whichever comes first:
|
| 2 years |
| Out-of-field Regional Control | Time to out-of-field regional failure is defined as the time from the date of registration to the date of the first record of appearance of regional progression/recurrence outside the treatment field , or to the date of neck dissection at any time after registration with tumour present/unknown performed for clinical or radiological disease progression outside the target volumes whichever comes first. The outcome is reported as the proportion of patients who remain out-of-field regional control free at 2 years. | 2 years |
| Distant Metastasis Free Survival | Distant metastasis free survival is defined as the time from the date of registration to the date of first record of appearance of distant metastasis or death for any cause. Local-regional failure or second cancers diagnosed before the distant metastases are not considered events of interest for this endpoint. Subjects alive and free of distant metastasis are censored at the date of the most recent follow-up examination. The outcome is reported as the proportion of patients who remain distant metastasis event-free at 2 years. | 2 years |
| Vancouver |
| British Columbia |
| V5Z 4E6 |
| Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Dr. H. Bliss Murphy Cancer Centre | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton | Ontario | L8V 5C2 | Canada |
| Kingston Health Sciences Centre | Kingston | Ontario | K7L 2V7 | Canada |
| Ottawa Hospital Research Institute | Ottawa | Ontario | K1H 8L6 | Canada |
| Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| University Health Network | Toronto | Ontario | M5G 2M9 | Canada |
| The Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| The Research Institute of the McGill University | Montreal | Quebec | H4A 3J1 | Canada |
| Hotel-Dieu de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| CIUSSS de l'Estrie - Centre hospitalier | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Allan Blair Cancer Centre | Regina | Saskatchewan | S4T 7T1 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Arm | Elective volume adjusted de-escalation radiotherapy. Option #1 - Radiotherapy 35 fractions, 5/wk, 7 wks 70Gy/56Gy Cisplatin 100mg/m2 on day 1, 22 and 43 or 40mg mg/m2/wk for 7 wks Option #2 - Radiation only-35 fraction, 6/wk, 6wks 70Gy/56Gy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| ECOG Performance Status | The ECOG Performance Status is a scale used to assess a patient's level of functioning. ECOG 0 indicates the patient fully active, able to carry on all pre-disease performance without restriction; ECOG 1 means the patient is restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work. | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Event-free Survival | Event free survival (EFS) is defined as the time from the date of registration to the date of first record of any of the following events:
| Posted | Number | 95% Confidence Interval | Percentage of patients event-free at 2y | 2 years |
|
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | For patients who have died, overall survival is calculated in months from the day of registration to date of death. Otherwise, overall survival is censored at the last day the patient is known alive (LKA). The outcome is reported as the proportion of patients who remain alive at 2 years. | Posted | Number | 95% Confidence Interval | Percentage of patients alive at 2 years | 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Local-regional Control | Local-regional control is defined as the time from the date of registration to the date of any of the following, whichever comes first:
| Posted | Number | 95% Confidence Interval | Percentage of patients LRC free at 2y | 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Out-of-field Regional Control | Time to out-of-field regional failure is defined as the time from the date of registration to the date of the first record of appearance of regional progression/recurrence outside the treatment field , or to the date of neck dissection at any time after registration with tumour present/unknown performed for clinical or radiological disease progression outside the target volumes whichever comes first. The outcome is reported as the proportion of patients who remain out-of-field regional control free at 2 years. | Posted | Number | 95% Confidence Interval | Percentages of patients ORC free at 2y | 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Distant Metastasis Free Survival | Distant metastasis free survival is defined as the time from the date of registration to the date of first record of appearance of distant metastasis or death for any cause. Local-regional failure or second cancers diagnosed before the distant metastases are not considered events of interest for this endpoint. Subjects alive and free of distant metastasis are censored at the date of the most recent follow-up examination. The outcome is reported as the proportion of patients who remain distant metastasis event-free at 2 years. | Posted | Number | 95% Confidence Interval | Percentages of patients DMF at 2y | 2 years |
|
|
Adverse events are assessed weekly during protocol therapy, then at 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 months post-radiotherapy, then every 6 months until 60 months post-radiotherapy or until recurrence/progression, and as clinically indicated thereafter.
Adverse events were collected and reported for all patients as a single group, without distinction between the two radiotherapy delivery options.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Arm | Elective volume adjusted de-escalation radiotherapy. Option #1 - Radiotherapy 35 fractions, 5/wk, 7 wks 70Gy/56Gy Cisplatin 100mg/m2 on day 1, 22 and 43 or 40mg mg/m2/wk for 7 wks Option #2 - Radiation only-35 fraction, 6/wk, 6wks 70Gy/56Gy | 6 | 100 | 8 | 100 | 100 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | CTCAE v 5.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE v 5.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE v 5.0 | Systematic Assessment |
| |
| Other gastrointestinal disorders | Gastrointestinal disorders | CTCAE v 5.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE v 5.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE v 5.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE v 5.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE v 5.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE v 5.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | CTCAE v 5.0 | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE v 5.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE v 5.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE v 5.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE v 5.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE v 5.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | CTCAE v 5.0 | Systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | CTCAE v 5.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE v 5.0 | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | CTCAE v 5.0 | Systematic Assessment |
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| Salivary duct inflammation | Gastrointestinal disorders | CTCAE v 5.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE v 5.0 | Systematic Assessment |
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| Other gastrointestinal disorders | Gastrointestinal disorders | CTCAE v 5.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE v 5.0 | Systematic Assessment |
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| Neck edema | General disorders | CTCAE v 5.0 | Systematic Assessment |
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| Pain | General disorders | CTCAE v 5.0 | Systematic Assessment |
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| Thrush | Infections and infestations | CTCAE v 5.0 | Systematic Assessment |
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| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE v 5.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE v 5.0 | Systematic Assessment |
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| Weight loss | Investigations | CTCAE v 5.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE v 5.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE v 5.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE v 5.0 | Systematic Assessment |
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| Superficial soft tissue fibrosis | Musculoskeletal and connective tissue disorders | CTCAE v 5.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE v 5.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | CTCAE v 5.0 | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE v 5.0 | Systematic Assessment |
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| Paresthesia | Nervous system disorders | CTCAE v 5.0 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | CTCAE v 5.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE v 5.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE v 5.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v 5.0 | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE v 5.0 | Systematic Assessment |
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| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE v 5.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE v 5.0 | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE v 5.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wendy Ranjana Parulekar | Canadian Cancer Trials Group | 613 533 6430 | wparulekar@ctg.queensu.ca |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 16, 2024 | Jun 16, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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