MedTrace Logo

CLEAR (Cervical Lymphatic Exclusion in Adjuvant Radiation)

NCT07755449 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2026-08-10

No results posted yet for this study

Summary

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

Conditions

  • Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

RADIATION

IMRT OR VMAT Radiotherapy excluding cervical radiation

30 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.

Sponsors & Collaborators

  • Institut Català d'Oncologia

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-13
Primary Completion
2027-07-13
Completion
2030-09-01

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07755449 on ClinicalTrials.gov