Radiation therapy for Head Neoplasms

Phase-Based Estimates
1
Effectiveness
1
Safety
Mays Cancer Center, San Antonio, TX
Head Neoplasms
Radiation therapy - Other
Eligibility
18+
All Sexes
Eligible conditions
Head Neoplasms

Study Summary

This study is evaluating whether a new computer program can help improve radiation treatment for patients with cancer.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Radiation therapy will improve 2 primary outcomes and 1 secondary outcome in patients with Head Neoplasms. Measurement will happen over the course of CT Simulation to first treatment (about 1 week).

Week 7
Maximum radiation dose to Organs at Risk (OAR)
Mean radiation dose to Organs at Risk (OAR)
Week 1
Time required to plan radiation therapy dose

Trial Safety

Trial Design

2 Treatment Groups

Control Arm
Research Arm
Placebo group

This trial requires 90 total participants across 2 different treatment groups

This trial involves 2 different treatments. Radiation Therapy is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Research ArmAfter 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.
Control Arm
Other
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to last treatment (up to 33 treatments or about 7 weeks)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to last treatment (up to 33 treatments or about 7 weeks) for reporting.

Closest Location

Mays Cancer Center - San Antonio, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient planned to undergo radiation therapy to treat their head and neck cancer. show original
Age ≥ 18 years.
Ability to provide consent in either English or Spanish. show original

Patient Q&A Section

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

Can head neoplasms be cured?

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The current therapies are more efficient than the pre-existing therapies. However, it is too late to say anything about the possibility of cure of the advanced neurogenic metastatic tumor with these available therapies.

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What is head neoplasms?

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Brain tumours are very diverse, and occur mainly in the adult age group. They most commonly occur in children and adolescents with frequency proportional to age. The most frequent type is gliomas (glioblastoma multiforme). Tumours of the pituitary gland are relatively uncommon and occur mainly in adults. The incidence of pituitary tumours increases with age; more and more elderly people are diagnosed with tumours, and the age group of the 30- to 70-year-old age bracket is an important one from a medical point of view. The most common pituitary tumours are adenomas; a minority of adenomas are malignant.

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What are common treatments for head neoplasms?

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The most popular treatment for head neoplasms, surgery, can be used to manage localized cases. The most popular option, which was used to treat more than 80% of cases, was surgery. However, head neoplasms are often metastatic. Because a surgery is not possible in most cases, it can be used less often to manage metastatic [brain tumor](https://www.withpower.com/clinical-tri[als](https://www.withpower.com/clinical-trials/als)/brain-tumor)s, brain neoplasms with intracranial extension, and other extracranial tumors that extend to the brain. This treatment approach is known as resection or debulking, though more complex therapies such as cranial irradiation may also be offered. Radiation can produce many side effects requiring careful management. Even metastatic cases can sometimes be managed with surgery.

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How many people get head neoplasms a year in the United States?

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It is estimated that about 45,000 malignant neoplasms of the central nervous system are diagnosed and about 23,000 people die of such diseases in the United States each year.talmoplasms.

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What causes head neoplasms?

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Head and neck cancer results from the interplay of genetics and lifestyle risks. Tobacco is the main substance responsible for most cases of head and neck cancer.

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What are the signs of head neoplasms?

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The signs and symptoms of head neoplasms arise principally from the growth of the abnormal brain tissue and may be nonspecific signs such as the presence of headache as well as signs that suggest specific pathology such as the presence of one or more focal neurological deficits on neurological examination. However, the presentation of neoplasms may be more specific such as the presence of a mass or focal neurological deterioration.

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How quickly does head neoplasms spread?

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The incidence and rate of CNS tumors in this cohort were much more than that found in other series, although the disease-specific survival was very good (<25%).

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Have there been any new discoveries for treating head neoplasms?

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New therapies that are being explored in clinical trials can have significant potential in treatment of many types of tumors and thus could bring about a new era for treatment options.

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Is radiation therapy typically used in combination with any other treatments?

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Many metastatic and/or unresectable head and neck cancers are commonly treated with radiotherapy plus chemotherapy. The use of radiation therapy in this setting varies according to the degree of response, the extent of disease, the age of the patient, the performance status of the patient, and the type of chemotherapy used. Although there is no optimal regimen, radiosurgery, stereotactic radiosurgery, and other minimally invasive techniques seem to achieve equivalent and higher local control rates than conventional external beam radiotherapy.

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Does head neoplasms run in families?

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In this large and well-defined population-based case-control study, no overall association was detected between neoplasm occurrence in patients with a family history of [head and neck cancer](https://www.withpower.com/clinical-trials/head-and-neck-cancer) and an increased risk of head-and-neck cancer. Head and neck cancer was associated with familial factors suggesting a role for environmental exposures and modifier genes.

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Does radiation therapy improve quality of life for those with head neoplasms?

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Data from a recent study indicate that overall quality of life is improved by treatment with EBRT in patients with surgically treatable head and neck malignancies, with acceptable side effects.

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What does radiation therapy usually treat?

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Radiation therapy commonly involves targets outside of the cranial cavity, as shown by the vast majority of cases. Given the current understanding of radiobiology, which indicates all radiation treatment can cause some damage to normal tissues, it seems the vast majority of cases would not cause significant cancer. However, even with the understanding of radiation-induced injury (described in the Radiobiology subsection), radiotherapy can still be a potentially dangerous treatment. A good analogy for radiation therapy is amputation, which requires sacrificing a full hand in order to remove the offending lesion; this is because amputated tissues do not divide and heal as well as intact tissue.

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