Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT07058805
Brief Summary:
COMPORT is a multicenter phase II clinical trial evaluating a personalized approach to postoperative radiotherapy in patients with head and neck squamous cell carcinoma (HNSCC). The study investigates whether a risk-adapted, compartmentalized radiotherapy strategy can safely reduce the treatment volume, and thus the side effects, without increasing the risk of tumor recurrence. Eligible patients are those with surgically treated cancers of the oral cavity, oropharynx, larynx, or hypopharynx who have a standard indication for postoperative radiotherapy. The primary outcome is the rate of recurrence in anatomical compartments that would normally be irradiated but are intentionally omitted in this study. COMPORT aims to generate high-level evidence to support a more personalized and less toxic standard of care in postoperative head and neck cancer management.
Detailed Description:
Background and Rationale:
Head and neck squamous cell carcinoma (HNSCC) is commonly treated with surgery followed by radiotherapy, but conventional large-volume irradiation leads to considerable toxicity. Previous studies, including retrospective work by the COMPORT team (Riggenbach et al. 2024), have shown that a compartmentalized, de-intensified radiotherapy approach may reduce morbidity without compromising oncologic outcomes.
Study Objective:
To evaluate the safety of omitting radiotherapy in selected anatomical compartments that would normally be treated based on standard guidelines (Evans et al. 2018/2025), using a pathology-driven stratification algorithm.
Design:
Bayesian, multicenter, single-arm phase II trial with 50 patients. The primary endpoint is the rate of recurrence in omitted (non-irradiated) compartments within 30 months. Secondary endpoints include loco-regional control, progression-free survival, overall survival, CTCAE-based toxicity scoring (TAME), and patient-reported quality of life (EORTC C30 + HN43).
Analysis Strategy:
The primary analysis will estimate the posterior probability that the recurrence rate in omitted (non-irradiated) compartments remains below a predefined threshold of 18%. If this probability exceeds 90%, the de-escalation strategy will be deemed successful. This would support the rationale for a future phase III randomized trial using a more conservative non-inferiority margin. A predefined interim safety analysis will be conducted once 20 patients have completed at least 6 months of follow-up.
Duration:
Accrual over 24 months, each patient followed for 30 months. Total study period: \~5.5 years.
Study:
NCT07058805
Study Brief:
Protocol Section:
NCT07058805