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SBRT + Immunomodulating Systemic Therapy for Inoperable, Recurrent H&N

NCT03402737 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-02-18

No results posted yet for this study

Summary

To derive the maximum tolerated dose of hypofractionated stereotactic body radiotherapy (SBRT) using dose painting by numbers with immunomodulating systemic therapy in patients that are reirradiated for recurrent squamous cell carcinoma of the head and neck.

Conditions

  • Head and Neck Neoplasm

Interventions

RADIATION

Stereotactic body radiotherapy

The range of dose-painting will be escalated in following levels: * 2x 6-8Gy (day 1-4) * 3x 6-8Gy (day 1-4-7) * 3x 6-10Gy (day 1-4-7) * 3x 6-12Gy (day 1-4-7) Patients will take cyclophosphamide orally 50 mg tablets, 1 tablet a day from the first day of irradiation for 8 consecutive weeks. Nivolumab will be considered as standard therapy in patients with cisplatin refractory locoregional disease recurrence. Nivolumab will be administered as per current standard of care. In case patients that are treated with nivolumab will be included in the trial, they will not be treated with cyclophosphamide.

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Fréderic Duprez, MD, PhD · Gent University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2020-12-03
Completion
2020-12-03

Countries

  • Belgium

Study Locations

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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 NCT03402737 on ClinicalTrials.gov