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Radiation Therapy

Radiation therapy for Head and Neck Cancers

N/A
Waitlist Available
Led By Sotirios Stathakis, PhD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years.
Ability to provide informed written consent in either English or Spanish.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to last treatment (up to 33 treatments or about 7 weeks)
Awards & highlights

Study Summary

This trial will help researchers develop a more precise and quicker radiation treatment plan that will decrease the time from when a patient is scanned to when they start treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to last treatment (up to 33 treatments or about 7 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to last treatment (up to 33 treatments or about 7 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum radiation dose to Organs at Risk (OAR)
Mean radiation dose to Organs at Risk (OAR)
Secondary outcome measures
Time required to plan radiation therapy dose

Side effects data

From 2013 Phase 3 trial • 397 Patients • NCT00004054
78%
Menopausal symptoms
60%
Urinary frequency
52%
Impotence
47%
Late RT Toxicity: Bladder: NOS
39%
Diarrhea NOS
27%
Late RT Toxicity: Bowel: NOS
26%
Fatigue
26%
Late RT Toxicity: Other GU: NOS
21%
Proctitis NOS
21%
Dysuria
14%
Libido decreased
14%
Dermatitis radiation NOS
12%
Late RT Toxicity: Other GI: NOS
12%
Late RT Toxicity: Other: NOS
12%
Hemoglobin decreased
12%
Alanine aminotransferase increased
9%
Gynaecomastia
8%
Urinary retention
7%
Pain-other
7%
Aspartate aminotransferase increased
6%
Rectal bleeding
6%
Constipation
6%
Leukopenia NOS
4%
Edema NOS
4%
Hematuria present
4%
Renal/GU-Other
3%
Arthralgia
3%
Blood creatinine increased
3%
Dyspnea NOS
3%
Dermatitis exfoliative NOS
2%
Nausea
2%
Hyperglycemia NOS
2%
Depression NEC
2%
Lymphopenia
2%
Myalgia
2%
Peripheral sensory neuropathy
1%
Stomatitis
1%
Blood albumin decreased
1%
Platelet count decreased
1%
Weight decreased
1%
Anorexia
1%
Hypocalcemia
1%
Hyponatremia
1%
Hematologic-Other
1%
Neutropenia
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hormones and RT
Hormones and RT Plus Chemotherapy

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Research ArmExperimental Treatment2 Interventions
After consent and study enrollment the subject will be scheduled for CT simulation for radiation treatment planning. At the time of CT simulation, they will be immobilized by means of a thermoplastic mask. For patients in the research arm, a theoretical plan will be created after physician's segmentation and will be used as a guide for the final plan. The patient will return for validation of the radiation plan. Validation involves collecting on-table X-rays or cone beam CTs when the patient is in position for treatment, which is the standard of care. Most often, the date of validation will happen within 5 business days of the CT simulation.
Group II: Control ArmPlacebo Group1 Intervention
After consent and study enrollment the subject will be scheduled for CT simulation for radiation treatment planning. At the time of CT simulation, they will be immobilized by means of a thermoplastic mask. For patients in the control arm, the radiation treatment planning will proceed as normal. Treatment planning is performed on Pinnacle. The patient will return for validation of the radiation plan. Validation involves collecting on-table X-rays or cone beam CTs when the patient is in position for treatment, which is the standard of care. Most often, the date of validation will happen within 5 business days of the CT simulation.

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
450 Previous Clinical Trials
87,240 Total Patients Enrolled
Sotirios Stathakis, PhDPrincipal InvestigatorUT Health San Antonio

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is this clinical trial accommodating?

"Affirmative. Clinicaltrials.gov displays evidence that this research is still seeking participants, which was initially shared on December 16th 2021 and updated the following week. The trial requires 90 volunteers from a single medical centre to partake in the study."

Answered by AI

Is there still scope for individuals to join this clinical investigation?

"Correct. According to clinicaltrials.gov, this medical study is enrolling patients and was first posted on December 16th 2021. The last update occurred on the 20th of December with a goal of recruiting 90 participants from 1 centre."

Answered by AI
~6 spots leftby Mar 2025