NCT05674396

Brief Summary

To learn if it is effective to use advanced radiation treatment techniques (stereotactic radiation or "SBRT") to safely deliver a strong dose of radiation to your tumor in a shorter period of time than would typically be feasible with traditional methods.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
17mo left

Started Jun 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jun 2023Sep 2027

First Submitted

Initial submission to the registry

December 21, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

June 30, 2023

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

4.3 years

First QC Date

December 21, 2022

Last Update Submit

February 17, 2026

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires

    M. D. Anderson Symptom Inventory - Head \& Neck (MDASI-HN) score range from 0/10 (0-symptom has not been present)0 to 10 (10-the symptom was as bad as you can imagine it could be)

    through study completion; an average of 1 year.

Study Arms (2)

Traditional Palliation

EXPERIMENTAL

Participant will be randomized to standard radiation

Radiation: Traditional Palliation

Stereotactic body radiotherapy (SBRT)

EXPERIMENTAL

Participants will be randomized to receive (SBRT) Stereotactic body radiotherapy.

Radiation: Stereotactic body radiotherapy

Interventions

Stereotactic body radiotherapyRADIATION

Participants will receive radiation as per the schedule discussed with the study doctor.

Stereotactic body radiotherapy (SBRT)
Traditional PalliationRADIATION

Participants will receive radiation as per the schedule discussed with the study doctor.

Traditional Palliation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Willing to provide informed consent
  • Histologically confirmed squamous cell carcinoma
  • Primary tumor site in the head and neck (includes oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, salivary gland, and cutaneous subsites as well as tumors of unknown primary site)
  • Ineligible for curative intent treatment after multidisciplinary evaluation (including evaluation by radiation oncologist and surgeon followed by presentation at multidisciplinary tumor board prior to randomization)
  • Prior therapy including radiation, surgery, or systemic therapy is permitted unless further radiation is deemed inappropriate by the enrolling physician
  • Metastatic disease is permitted

You may not qualify if:

  • Contraindications to radiotherapy
  • Pregnant or lactating women
  • PRE-TREATMENT EVALUATION
  • History and physical examination including laryngopharyngoscopy by a radiation oncologist and/or head and neck surgeon within 8 weeks prior to randomization.
  • o Clinical examination will include a detailed description of disease target including measurement where feasible to facilitate response assessment
  • Documentation of smoking history
  • Staging imaging within 12 weeks prior to randomization:
  • Contrast-enhanced CT of the neck and chest or
  • MRI of the neck with CT of the chest or
  • Whole body PET/CT
  • Histological confirmation of squamous cell carcinoma
  • Pregnancy test for women of child-bearing age, within 2 weeks prior to randomization
  • Assessment of all baseline symptoms, using CTCAE version 5.0 within 2 weeks prior to randomization.
  • Assessment of baseline pain score (NRS) and analgesic use (non-opioid and opioid)
  • Completion of QOL scoring within 2 weeks of randomization
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jay Reddy, MD,PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jay Reddy, MD,PHD

CONTACT

(832) 750-2924jreddy@mdanderson.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 6, 2023

Study Start

June 30, 2023

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations

US(1)