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3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05674396
Collaborator
(none)
108
Enrollment
1
Location
2
Arms
51
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Stereotactic body radiotherapy
  • Radiation: Traditional Palliation
 Phase 2

Detailed Description

Objectives:

  • To compare local progression-free survival following palliation with SBRT versus traditional fractionations in patients with HN SCC deemed ineligible for curative-intent treatment.

  • To compare pain response, symptom burden, toxicity, local control, progression-free survival, and overall survival between the treatment modalities.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial
Anticipated Study Start Date :
Jun 30, 2023
Anticipated Primary Completion Date :
Sep 30, 2025
Anticipated Study Completion Date :
Sep 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Traditional Palliation

Participant will be randomized to standard radiation

Radiation: Traditional Palliation
Participants will receive radiation as per the schedule discussed with the study doctor.
Experimental: Stereotactic body radiotherapy (SBRT)

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

Radiation: Stereotactic body radiotherapy
Participants will receive radiation as per the schedule discussed with the study doctor.

Outcome Measures

Primary Outcome Measures

  1. M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires [through study completion; an average of 1 year.]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Contraindications to radiotherapy

  • Pregnant or lactating women

5.0 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

  • Informed consents must be obtained prior to any study specific activities

Contacts and Locations

Locations

Site City State Country Postal Code
1 M D Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Jay Reddy, MD,PHD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT05674396
Other Study ID Numbers:
  • 2022-0648
  • NCI-2022-10828
First Posted:
Jan 6, 2023
Last Update Posted:
Jan 6, 2023
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck

Study Results

No Results Posted as of Jan 6, 2023