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Stereotactic Body Radiation Therapy for Head and Neck Squamous Cell Carcinoma

Phase 2
Waitlist Available
Led By Jack Phan
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with biopsy proven locoregional recurrent squamous cell carcinoma of the head and neck, or second primary HNSCC
Not eligible (unresectable) or poor candidate or patient refusal of surgery for HNSCC recurrence
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from nbtxr3 injection to the radiographic and/or histological confirmation of local (within 2 cm of the high-dose reirradiation treatment volume [ptv]) disease recurrence, local progression, or death from any cause, assessed up to 5 years
Awards & highlights

Study Summary

This trial is testing a new way to treat head and neck squamous cell cancer that has come back by giving a drug that is activated by radiation therapy together with immunotherapy.

Eligible Conditions
  • Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from nbtxr3 injection to the radiographic and/or histological confirmation of local (within 2 cm of the high-dose reirradiation treatment volume [ptv]) disease recurrence, local progression, or death from any cause, assessed up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from nbtxr3 injection to the radiographic and/or histological confirmation of local (within 2 cm of the high-dose reirradiation treatment volume [ptv]) disease recurrence, local progression, or death from any cause, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Early clinical benefit activated by SBRT reirradiation
Incidence of acute adverse events activated by dose reduction IMRT or IMPT reirradiation
Incidence of late adverse events activated by SBRT reirradiation
+2 more
Secondary outcome measures
Distant PFS
Incidence of acute adverse events activated by SBRT reirradiation
Local PFS
+4 more
Other outcome measures
Biomarkers of response
Evaluation of the clinical-grading of lymphedema/fibrosis
Patient reports outcomes

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort II (NBTXR3, IMRT/IMPT, pembrolizumab)Experimental Treatment6 Interventions
Patients receive NBTXR3 IT on day 1. Patients then undergo IMRT/IMPT QD on days 15-50. Beginning the first day of radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Cohort I (NBTXR3, SBRT, pembrolizumab)Experimental Treatment5 Interventions
Patients receive NBTXR3 IT on day 1. Patients then undergo SBRT QOD on days 15-29. Beginning the first day of radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,352 Total Patients Enrolled
Jack PhanPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
100 Total Patients Enrolled
Jack Phan, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives are the researchers striving to reach with this investigation?

"This clinical trial's primary endpoint is to measure the rate of late onset side-effects associated with dose reduction IMRT and IMPT reirradiation after 6 months post radiation therapy. Other secondary objectives include evaluating acute adverse events, overall response per RECIST v1.1 standards, regional PFS estimated by Kaplan-Meier estimates, as well as median times & 95% confidence intervals calculated from these metrics."

Answered by AI

In what applications is Hafnium Oxide-containing Nanoparticles NBTXR3 typically employed?

"NBTXR3, a nanoparticle containing hafnium oxide, can be employed to treat malignant neoplasms, inoperable melanoma, and microsatellite instability high."

Answered by AI

Can you provide an assessment of the potential harms associated with Hafnium Oxide-containing Nanoparticles NBTXR3?

"Relying on the evidence available in a Phase 2 trial, our team at Power settled on an estimated safety rate of 2 for Hafnium Oxide-containing Nanoparticles NBTXR3. Though there is data that supports its security, efficacy has yet to be proven."

Answered by AI

What is the current size of the cohort enrolled in this trial?

"Unfortunately, at the present moment this research is not seeking participants. It was first launched on March 9th 2021 and last updated on May 23rd 2022. Those searching other trials may find 3462 studies recruiting patients with oral squamous cell carcinoma and another 961 for Hafnium Oxide-containing Nanoparticles NBTXR3 actively enrolling volunteers."

Answered by AI

Is this study inviting new participants to join?

"As of now, this particular study is not enrolling any additional patients. It was first advertised on March 9th 2021 and the listing was most recently modified on May 23rd 2022. For those looking for alternate trials that might be suitable, there are 3462 clinical studies recruiting participants with oral squamous cell carcinoma and an additional 961 medical investigations actively searching for volunteers to partake in Hafnium Oxide-containing Nanoparticles NBTXR3 trial."

Answered by AI

Have any other experiments been conducted to evaluate the efficacy of Hafnium Oxide-containing Nanoparticles NBTXR3?

"At present, there are 961 active clinical trials examining the effects of Hafnium Oxide-containing Nanoparticles NBTXR3 with 122 in Phase 3. Houston, Texas is among many locations running these tests - 35727 to be exact."

Answered by AI
~0 spots leftby Mar 2025