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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

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Stereotactic body radiotherapy
Traditional Palliation
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Traditional Palliation

Stereotactic body radiotherapy (SBRT)

Arm Description

Participant will be randomized to standard radiation

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
December 21, 2022
Last Updated
July 6, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05674396
Brief Title
3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial
Official Title
3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2023 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional Palliation
Arm Type
Experimental
Arm Description
Participant will be randomized to standard radiation
Arm Title
Stereotactic body radiotherapy (SBRT)
Arm Type
Experimental
Arm Description
Participants will be randomized to receive (SBRT) Stereotactic body radiotherapy.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic body radiotherapy
Intervention Description
Participants will receive radiation as per the schedule discussed with the study doctor.
Intervention Type
Radiation
Intervention Name(s)
Traditional Palliation
Intervention Description
Participants will receive radiation as per the schedule discussed with the study doctor.
Primary Outcome Measure Information:
Title
M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires
Description
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)
Time Frame
through study completion; an average of 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jay Reddy, MD,PHD
Phone
(832) 750-2924
Email
jreddy@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Reddy, MD,PHD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jay Reddy, MD, PHD
Phone
832-750-2924
Email
jreddy@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Jay Reddy, MD, PHD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

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

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