NCI Trial Investigates Chemotherapy and Immunotherapy for Recurrent Head and Neck Cancer
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A National Cancer Institute-funded phase 2 clinical trial (NCT07195734) is now actively enrolling patients to determine if pre-surgical treatment can improve survival rates for individuals facing a recurrence of head and neck squamous cell carcinoma following prior radiation therapy. The study, representing a critical step forward in addressing a challenging cancer, compares the effectiveness of surgery alone against a combination of neoadjuvant chemotherapy with or without immunotherapy.
Up to 40% of patients with head and neck cancer experience a recurrence,often facing a grim prognosis.Currently, surgery remains the standard of care, but it can be profoundly debilitating and doesn’t always guarantee long-term survival. “Surgical intervention for recurrence, while potentially curative, is frequently enough profoundly debilitating and is still associated with suboptimal survival,” a senior official stated. “This trial seeks to determine if systemic therapy administered prior to surgery can extend disease-free and overall survival for these patients.”
Trial Design and Treatment Arms
Eligible patients who are candidates for salvage surgery will be randomly assigned to one of three treatment arms. Arm 1 involves neoadjuvant chemotherapy utilizing carboplatin and paclitaxel, administered intravenously every 21 days for two cycles, provided the patient doesn’t experience disease progression or unacceptable toxicity. Arm 2 combines the same chemotherapy regimen with the anti-PD-L1 immunotherapy cemiplimab (Libtayo), also administered intravenously for two cycles. Arm 3 consists of surgery alone.
The inclusion of cemiplimab is based on the high levels of PD-L1 expression frequently observed in head and neck cancers,suggesting a potential responsiveness to immune checkpoint inhibition. Patients in arm 3 who exhibit high-risk pathological features will receive adjuvant radiation therapy within eight weeks of surgery, delivered daily for six weeks, five treatments per week.
Monitoring and Objectives
Following completion of their assigned treatment,patients will undergo follow-up assessments at 12 weeks,or at the conclusion of any post-operative radiation. Subsequent monitoring will occur every three months for two years, every six months for years three and four, and annually thereafter.
The primary objective of the trial is to evaluate event-free survival (EFS) in patients receiving chemotherapy or chemo-immunotherapy before salvage surgery, compared to those undergoing surgery as the initial treatment. Secondary objectives include assessing disease-free survival (DFS), overall survival (OS), and the occurrence of distant metastasis. Exploratory outcomes will also analyse EFS, DFS, and OS.
Ensuring Radiotherapy Precision
The study emphasizes the importance of standardized treatment delivery across participating institutions. “Our contribution has focused on ensuring the technical precision and consistency of radiotherapy parameters across participating sites, which is vital for a multi-institutional study of this nature,” explained a lead medical physicist. This meticulous approach aims to minimize variability and ensure the reliability of the trial’s findings.
This clinical trial represents a significant effort to improve outcomes for patients with recurrent head and neck squamous cell carcinoma, offering the po
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