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HFHS-1801-A Pilot Study of Immunotherapy as Consolidation Therapy for Patients With Recurrent Head and Neck Cancer

Head and Neck Neoplasms Clinical Trial

Official title:
HFHS-1801-A Pilot Study of Immunotherapy as Consolidation Therapy for Patients With Recurrent Head and Neck Cancer High Risk Pathologic Features Following Surgical Salvage and Are Not Eligible for Post-operative Radiation Therapy

Clinical Trial Summary

The study is a pilot study to explore the feasibility and efficacy of immunotherapy following salvage surgery for recurrent head and neck cancer.

Clinical Trial Description

Approximately 30-40% of patients treated with a curative intent for locally advanced squamous cell carcinoma of the head and neck cancer will experience an isolated loco-regional recurrence or a second primary tumor in the previously radiated tissues1-5. Patients with recurrent head and neck cancer frequently recur locally and are still amenable for curative interventions. The current recommendations for treatment of these recurrent and second primary tumors includes surgical resection whenever possible as this has been shown to have a significantly better outcome as compared to patients treated non-surgically with radiation therapy with or without concurrent chemotherapy. Immunotherapy is expected to be more effective with smaller amounts of disease and application of therapy when disease burden is minimal is expected to yield improved outcomes. Many trials underway at the present time explore the use of immunotherapy in earlier stages of head and neck cancer than the ones already studied. However, patients undergoing salvage therapy are understudied and no major cooperative group or industry trial is addressing this group of patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04188951
Study type Interventional
Source Henry Ford Health System
Contact John Gaggin, BSN
Phone 313-916-3731
Email JGAGGIN1@hfhs.org
Status Recruiting
Phase Early Phase 1
Start date October 4, 2019
Completion date December 30, 2023
View Details
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