Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer
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|ClinicalTrials.gov Identifier: NCT03521570|
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : March 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Head and Neck Squamous Cell Carcinoma||Radiation: IMRT Biological: Nivolumab||Phase 2|
I. To assess the 1-year progression-free survival (PFS) for patients with recurrent or second primary head and neck squamous cancer treated with intensity-modulated radiation therapy (IMRT) re-irradiation with concurrent and adjuvant nivolumab.
I. Evaluate the 1-year (yr) overall survival (OS) of patients treated with re-irradiation and nivolumab.
II. Evaluate patient quality of life (QOL).
III. Evaluate patterns of failure including local, regional and distant failure rates at 1 yr.
IV. Identify and estimate the incidence rate of acute and late toxicities associated with combined re-irradiation and concurrent and adjuvant nivolumab.
I. To identify potential biomarkers related to clinical benefit to concurrent and adjuvant nivolumab and re-irradiation in patients with recurrent or second primary (RSP) head and neck squamous cell carcinoma (HNSCC).
Patients receive nivolumab intravenously (IV) over 30 minutes on weeks -2, 0, 2, 4, and 6 and undergo IMRT once daily beginning on week 0 for up to 6-6.5 weeks. Beginning week 10, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 2 years from the beginning of radiation therapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of IMRT Re-Irradiation With Concurrent/Adjuvant Nivolumab in Patients With Locoregionally Recurrent or Second Primary Squamous Cell Cancer of the Head and Neck|
|Actual Study Start Date :||June 28, 2018|
|Estimated Primary Completion Date :||January 19, 2022|
|Estimated Study Completion Date :||January 19, 2022|
Experimental: Treatment (nivolumab, IMRT)
Patients receive nivolumab IV over 30 minutes on weeks -2, 0, 2, 4, and 6 and undergo IMRT once daily beginning on week 0 for up to 6-6.5 weeks. Beginning week 10, patients receive nivolumab IV over 30 minutes every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
Undergo intensity-modulated radiation therapy
- 1 year progression-free survival (PFS) [ Time Frame: 1 year from study start ]95% confidence interval will be estimated by Kaplan-Meier method for all participants.
- 1 year overall survival (OS) [ Time Frame: 1 year from study start ]Will be assessed using Kaplan-Meier method.
- Pattern of failure [ Time Frame: 1 year from study start ]To evaluate patterns of failure as local, regional, or distant.
- Incidence of acute adverse events [ Time Frame: Up to 1 year from study start ]Acute toxicities will be identified and their incidence rate estimated.
- Incidence of late adverse events [ Time Frame: 2 years from study start ]Late toxicities will be identified and their incidence rate estimated.
- Quality of life (QOL) [ Time Frame: Up to 2 years from study start ]The Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) Quality of Life (QOL) assessments will be performed at baseline, end of IMRT, and weeks 18, 30, 52, and 104. Paper or electronic questionnaires may be completed by the patient.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521570
|Contact: Nabil F. Saba, MDfirstname.lastname@example.org|
|United States, Georgia|
|Emory University Hospital Midtown||Recruiting|
|Atlanta, Georgia, United States, 30308|
|Contact: Allyson Anderson 404-686-0239 email@example.com|
|Contact: Shraddha Dubal 404-686-3258 firstname.lastname@example.org|
|Principal Investigator: Nabil F. Saba, MD|
|Emory University Hospital/Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Erin Davis 404-778-1805 email@example.com|
|Contact: Tanie Soji 404-778-4582 firstname.lastname@example.org|
|Principal Investigator: Nabil F. Saba, MD|
|United States, Ohio|
|Cleveland Clinic Foundation||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Shlomo A. Koyfman, MD KOYFMAS@ccf.org|
|Contact: Allison Horner 216-445-6354 email@example.com|
|Principal Investigator: Shlomo A. Koyfman, MD|
|United States, Wisconsin|
|Froedtert and the Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Stuart J. Wong, MD 866-680-0505 firstname.lastname@example.org|
|Principal Investigator: Stuart J. Wong, MD|
|Principal Investigator:||Nabil F. Saba, MD||Emory University|