To hear about similar clinical trials, please enter your email below
Trial Title:
3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial
NCT ID:
NCT05674396
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Stereotactic body radiotherapy
Description:
Participants will receive radiation as per the schedule discussed with the study doctor.
Arm group label:
Stereotactic body radiotherapy (SBRT)
Intervention type:
Radiation
Intervention name:
Traditional Palliation
Description:
Participants will receive radiation as per the schedule discussed with the study doctor.
Arm group label:
Traditional Palliation
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jay Reddy, MD, PHD
Phone:
832-750-2924
Email:
jreddy@mdanderson.org
Investigator:
Last name:
Jay Reddy, MD, PHD
Email:
Principal Investigator
Start date:
June 30, 2023
Completion date:
September 30, 2027
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05674396
http://www.mdanderson.org
