Personalized elective neck irradiation guided by sentinel lymph node biopsy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx with a clinically negative neck: (chemo)radiotherapy to the PRIMary tumor Only. The PRIMO study.
- Conditions
- head and neck cancerlaryngeal canceroropharyngeal cancerpharyngeal cancersquamous cell carcinoma10027655
- Registration Number
- NL-OMON56453
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 242
- Adult patients with newly diagnosed cT1-4N0M0 squamous cell carcinoma of the
oropharynx, larynx or hypopharynx.
- Histopathological diagnosis of squamous cell carcinoma in the primary tumor.
- Adequate staging of the neck including CT or MRI, and PET/CT demonstrating
cN0.
- Recommendation for curative intent external beam (chemo)radiotherapy made by
a multidisciplinary head and neck oncology team
- Bilateral elective neck irradiation is indicated according to Dutch consensus
guidelines (LPHHRT)
- Procedures for sentinel lymph node biopsy are deemed feasible by the head and
neck surgeon.
- Recurrent disease or previous anticancer treatment to the head and neck area
except for endoscopic glottic laser micro surgery.
- Well lateralized oropharyngeal cancers and early stage laryngeal cancers
requiring no or unilateral elective neck irradiation according to Dutch
consensus guidelines (LPHHRT).
- Patients receiving concomitant non-platinum-based systemic agents (e.g.
cetuximab).
- Patients that qualify for proton therapy and want to be treated accordingly.
- Compromised airway or tracheostomy.
- Any active invasive malignancy within the last 3 years except for early stage
basal/squamous cell carcinoma of the skin and incidental finding of stage
T1N0M0 prostate cancer.
- Any somatic, psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol or follow-up schedule.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary safety endpoint is the number of patients with recurrence in<br /><br>regional lymph nodes (in the absence of synchronous recurrence of the primary<br /><br>tumor or second primary tumor) within 2 years after treatment. The primary<br /><br>efficacy endpoint is patient reported xerostomia-related quality of life<br /><br>measured by the xerostomia symptom scale of the EORTC QLQ-H&N35 at 6 months<br /><br>after treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Acute and late radiation toxicity, quality of life after treatment with focus<br /><br>on xerostomia and dysphagia, local and regional control rates, disease specific<br /><br>and overall survival, and cost-effectiveness. </p><br>