Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-25 @ 4:57 PM
Study NCT ID:
NCT06080503
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2023-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Randomized Study of Hypofractionated Versus Conventional Radiotherapy
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
G-FORCE: Phase II Randomized Study of Glottic Larynx Hypofractionated Radiotherapy Versus ConvEntional Radiotherapy
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
G-FORCE
Brief Summary:
To compare the acute tolerance of highly conformal hypofractionated versus conventional radiotherapy.
Detailed Description:
Screening/Baseline Procedures Assessments performed exclusively to determine eligibility for this study will be done only after obtaining informed consent. Assessments performed for clinical indications (not exclusively to determine study eligibility) may be used for baseline values even if the studies were done before informed consent was obtained.
All screening procedures must be performed within 30 days prior to registration into the study unless otherwise stated. The screening procedures include:
Informed Consent Medical history--Complete medical and surgical history Demographics--Age, gender, race, ethnicity Review subject eligibility criteria Review previous and concomitant medications Physical exam including vital signs, height and weight Vital signs (temperature, pulse, respirations, blood pressure), height, weight Performance status--Performance status evaluated prior to study entry. If there is any variability in the physicians' notes, the higher number will be used for research purposes.
Positron emission tomography-computerized tomography or computerized tomography of neck (any time prior to registration) Laryngoscopy Pregnancy test (for females of child-bearing potential) Quality of life Questionnaires and Symptom Questionnaires --EORTC QLQ-C30, H\&N 35, VHI, and EQ-5D. These forms will be referred to collectively as QoL Questionnaires. Can be given on paper, over the phone, or in EPIC as needed.
Procedures During Treatment Day 1-First fraction of radiotherapy per standard, departmental stereotactic protocol
Follow-up Procedures--After initial follow-up at 2 weeks (+/- 7 days) after completion of radiation therapy, subjects will be followed at 3 months and 12 months. These protocol mandated procedures will occur at each follow-up:
Interim history Physical exam, vital signs, ECOG Performance Status Laryngoscopy (optional at 1-2 weeks) to assess tumor response and toxicity Quality of life and voice quality assessment. Can be given on paper, over the phone, or in EPIC as needed.
All screening procedures must be performed within 30 days prior to registration into the study unless otherwise stated. The screening procedures include:
Informed Consent Medical history--Complete medical and surgical history Demographics--Age, gender, race, ethnicity Review subject eligibility criteria Review previous and concomitant medications Physical exam including vital signs, height and weight Vital signs (temperature, pulse, respirations, blood pressure), height, weight Performance status--Performance status evaluated prior to study entry. If there is any variability in the physicians' notes, the higher number will be used for research purposes.
Positron emission tomography-computerized tomography or computerized tomography of neck (any time prior to registration) Laryngoscopy Pregnancy test (for females of child-bearing potential) Quality of life Questionnaires and Symptom Questionnaires --EORTC QLQ-C30, H\&N 35, VHI, and EQ-5D. These forms will be referred to collectively as QoL Questionnaires. Can be given on paper, over the phone, or in EPIC as needed.
Procedures During Treatment Day 1-First fraction of radiotherapy per standard, departmental stereotactic protocol
Follow-up Procedures--After initial follow-up at 2 weeks (+/- 7 days) after completion of radiation therapy, subjects will be followed at 3 months and 12 months. These protocol mandated procedures will occur at each follow-up:
Interim history Physical exam, vital signs, ECOG Performance Status Laryngoscopy (optional at 1-2 weeks) to assess tumor response and toxicity Quality of life and voice quality assessment. Can be given on paper, over the phone, or in EPIC as needed.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: