Advanced Head and Neck Cancer
Conditions
Brief summary
This study is being done to answer the following question: Does stereotactic body radiation therapy (SBRT) provide better cancer control compared to standard radiation therapy (RT) for those with advanced head and neck cancer?
Detailed description
Stereotactic body radiation therapy, or SBRT, is a cancer treatment that more precisely delivers radiation to the tumour area with less radiation going to unaffected areas around the tumour. It uses fewer treatments of higher doses compared to standard radiation therapy. This study is being done to find out if this approach is better than the usual approach for advanced head and neck cancer. The usual approach is defined as care most people get for advanced head and neck cancer.
Interventions
RADIATIONStandard Radiotherapy (SRT)
2400 cGy in 3 fractions - day 0/7/21, OR, 2500 cGy in 5 fractions over 1 week
RADIATIONStereotactic Body Radiotherapy (SBRT)
4500 cGy in 5 fractions (twice a week to primary and nodal GTV, OR, 4000 cGy in 5 fractions twice a week if organs at risk.
Sponsors
Canadian Cancer Trials Group
Canadian Institutes of Health Research (CIHR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed mucosal squamous cell carcinoma (SCC) of the head and neck arising from at least one of the following sites: oro/hypopharynx, oral cavity, supraglottic larynx, maxillary sinus, nasal cavity, or unknown primary * Stages TX or T0-T4/N0-N3 * Must be considered unfit for curative intent RT as determined by the treating oncologist(s) * Geriatric 8 score \<14 * Patient must be ≥18 years of age * Staging CT or MRI of the head and neck within 8 weeks prior to randomization * Chest CT or x-ray. PET CT is permitted if CT is of diagnostic quality. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3 * Participants of childbearing potential must have agreed to use a highly effective contraceptive method during protocol therapy. * Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational treatment are eligible for this trial.
Exclusion criteria
* Patients with nasopharyngeal carcinoma. * Prior systemic therapy (including immunotherapy). * Prior radiotherapy to the head and neck excluding superficial radiotherapy for head and neck skin cancer that does not overlap with current protocol treatment. * Prior head and neck cancer excluding skin cancer. * Patients with tumour locations/at risk of SBRT toxicity, including glottic/subglottic larynx, T4 hypopharynx, post-cricoid, cervical esophagus, circumferential pharyngeal involvement, extension/proximity to brain/optic structures, any single tumour mass \>8 cm (in one dimension). * \> 2 nodal levels (Level 1a/b not counted); retropharyngeal lymph nodes (where the closest edge is \< 2cm from the closest edge of CTV (primary or nodal) will not be considered as a different level). Note: a single lymph node mass that spans 2 levels will be considered as 1 level. * Gross tumour poorly visualized on CT/MRI. * Definitive radiological or clinically evident distant metastases. * Scleroderma/CREST syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival estimated according to Kaplan-Meier's methodology | 6 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | 6 years | — |
| Local Regional Failure Free Survival | 6 years | defined as the time from the date of randomization to the date of any of the following, whichever comes first: * The first record of appearance (radiological or clinical) of local or regional disease progression/recurrence. * Surgery of primary tumour at any time performed for clinical or radiological (RECIST 1.1) disease persistence/progression/recurrence with tumour present/unknown on final pathology. * Neck dissection \> 20 weeks from the end of radiation therapy performed for clinical or radiological (RECIST 1.1) disease persistence/progression/recurrence with tumour present/unknown on final pathology. |
| Response Rate evaluated by RECIST | 6 years | — |
| Number and Severity of Adverse Events | 6 years | — |
| Patient Reported Outcomes utilizing PRO-CTCAE | 6 years | We will qualitatively compare PRO-CTCAE item scores between arms at 8 weeks from the start of RT, and examine PRO-CTCAE item scores at 12 months post-RT in the SBRT arm, as an indicator or persisting (consequential or "late") RT toxicity with SBRT to the head and neck region. |
| Patient Reported Outcomes utilizing FACT-HN | 6 years | proportion of patients between arms who have a meaningful worsening (12 points or greater) of QOL |
| Healthcare Resource Utilization utilizing EQ-5D-5L | 6 years | All enrolled participants who have received at least one fraction of protocol therapy are evaluable for health economics. Those who have completed the Health Utilities Index (EQ-5D-5L), will be evaluable for cost-utility analyses. |
Countries
Canada
Contacts
CONTACTWendy Parulekar
STUDY_CHAIRIan Poon
Odette Cancer Centre, Sunnybrook Health Sciences, UHN, Toronto, ON Canada
Outcome results
None listed