CLEAR (Cervical Lymphatic Exclusion in Adjuvant Radiation)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Català d'Oncologia
About this trial
The goal of this clinical trial is to learn if selectively omitting postoperative cervical irradiation is a safe and feasible treatment strategy for patients with resected, locally advanced squamous cell carcinoma of the head and neck (HNSCC) who underwent systematic neck dissection and have no high-risk nodal factors. The main questions it aims to answer are:
* Is the regional recurrence rate with selective omission of postoperative cervical irradiation non-inferior to the recurrence rate reported with standard complete nodal irradiation (6-8%)? * Does selective omission of postoperative cervical irradiation reduce toxicity? * Does selective omission of postoperative cervical irradiation improve immunological preservation and quality of life?
Researchers will compare outcomes in participants treated with this selective irradiation strategy to previously published data and to a retrospective institutional cohort treated with standard complete nodal irradiation, to see if it maintains regional control while reducing toxicity and preserving immune function and quality of life.
Participants will:
* Receive postoperative radiotherapy according to the new protocol, omitting irradiation of low-risk nodal levels * Receive concomitant chemotherapy if clinically indicated, per standard practice * Visit for checkups, blood sample collection, to complete quality-of-life questionnaires and attend follow-up visits over 48 months
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 18 years of age
ECOG Performance Status (PS) ≤ 2
Histologically confirmed diagnosis of locally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
Resection of the primary tumor and unilateral and/or bilateral neck dissection performed according to standard guidelines, with detailed histological reporting by nodal level
Disqualifiers
Absence of informed consent
Prior irradiation to the head and neck region
Prior surgery in the head and neck region
Contralateral neck dissection not performed when clinically indicated
Trial design
Design model
Single group
Treatments tested in this trial
IMRT OR VMAT Radiotherapy excluding cervical radiation
Radiation30 or 33 sessions of radiotherapy 2 Gy sessions until 60 or 66 Gy will be administered to the primary tumor bed. Concomitant cisplatin chemotherapy may be administered per standard clinical practice in patients with high-risk primary tumor features (positive or close \[\<5 mm\] margins), when not clinically contraindicated.
Treatment groups
101 Participants
are divided into 1 treatment groupGroup A: Selective postoperative radiotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Regional recurrence rate in non-irradiated cervical levels
Rate to be compared to the recurrence rate reported with standard complete nodal irradiation (6-8%)
Time frame
At 24 monthsSecondary outcomes
1
Local and Regional Progression-Free Survival
Will be estimated using the Kaplan-Meier method, assessed in both the intention-to-treat and per-protocol populations, with the per-protocol population as the basis for the final analysis.
Time frame
1 and 2 years2
Distant Metastasis-Free Survival
Distant metastasis-free survival will be estimated using the Kaplan-Meier method, assessed in both the intention-to-treat and per-protocol populations, with the per-protocol population as the basis for the final analysis.
Time frame
1 and 2 years3
Overall Survival
will be estimated using the Kaplan-Meier method, assessed in both the intention-to-treat and per-protocol populations, with the per-protocol population as the basis for the final analysis
Time frame
1 and 2 years4
Incidence of Acute and Chronic Toxicity
Will be assessed using CTCAE v5.0. Cumulative incidence will be analyzed by grade and affected organ/system along with prevalence, in the safety population.
Time frame
3, 6, 12 and 24 monthsSponsors and contacts
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Source ClinicalTrials.gov