Patient Observation for Head Neoplasms
This study is evaluating whether radiation treatment to the neck only for tumors with unclear original locations after careful surgical evaluation will lead to historical rates of disease control while reducing side effects and toxicity from treatment.
See full descriptionAbout the trial for Head Neoplasms
Treatment Groups
This trial involves 2 different treatments. Patient Observation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.
Eligibility
This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Patient Observation will improve 1 primary outcome and 7 secondary outcomes in patients with Head Neoplasms. Measurement will happen over the course of Up to 1 month post radiation therapy (XRT).
Patient Q & A Section
How many people get head neoplasms a year in the United States?
Approximately 40,000 people are diagnosed with a glioma and 80,000 with a head and neck cancer per year in the U.S. Half of gliomas occur in women.
Can head neoplasms be cured?
The findings from epidemiological studies show that the overall incidence of cancer of the head is about the same in various countries. However, the average survival is much longer in countries where brain tumors are more common than in countries with less frequent cases. As life expectancy increases, the probability of survival of individuals with cancers of the mouth or head and neck will be decreased. However, head cancers are relatively rare compared to lung and breast cancers, and a cure is not guaranteed with the current treatment for head tumors (see cure notes).
What are the signs of head neoplasms?
Head cancers may have a variety of clinical features, some of which can mimic others. Most patients with head cancer demonstrate clinical signs. The clinical signs of metastatic disease include nausea, vomiting, anorexia, and abdominal pain. The clinical presentation of malignant tumors of the brain and spinal cord can vary depending on tumor site. Clinical signs can also be caused by other conditions. The clinical presentation and response to therapy are similar between benign and malignant lesions. These lesions occur in many parts of the body. To simplify diagnosis, a biopsy may be useful. Diagnostic findings on a biopsy sample for malignant tumors include anaplasia and necrosis.
What causes head neoplasms?
Infection, smoking, immunological dysregulation, and radiation may all be associated with a higher risk of developing head neoplasms. We found no evidence that dietary factors, nutritional status, or metabolic disorders play a significant role in the development of head neoplasms. The risk of developing head and neck cancer is not higher in those with type 1 or type 2 diabetes.
What is head neoplasms?
Head tumors represent a wide spectrum of disease with overlapping presentations and can occur in the same child. Most head tumors are benign lesions. Because of their high cure rate when they are monitored carefully, head tumors are not a reason for refusing to allow a child to return to normal activities. In some children, head trauma may be associated with increased risk of gliomas.
What are common treatments for head neoplasms?
A variety of treatments are used for head neoplasms which are widely considered as challenging in their clinical management. The extent and types of therapies can be evaluated through the use of this meta-analysis system.
What is patient observation?
One of the greatest difficulties in neuro-oncology management is identifying patient observation as an acceptable treatment option when available in the context of quality improvement initiatives. The patient's desire for optimal treatment outcomes is the main determinant of patient satisfaction with treatment. These data suggest that patient-directed care could be a useful tool in expanding patient access to effective care through quality improvement methods. Patient's preference for observation as a treatment option may facilitate quality improvement initiatives by allowing for the development of a multidisciplinary team approach to care planning. As a whole, these data imply that expanding patient access to patient care services could improve outcomes of care and improve patient satisfaction.
Is patient observation safe for people?
Patients did not want to be observed following standard treatment because of fear of loss of self-determination, and some felt that doctors were not trained to be their "guardians," and thus could not fulfill this role adequately. However, patients generally preferred to be observed after treatment because they felt that doctors gave them good treatment. When asked to consider the patient's interests, and how it could "negatively" impact treatment outcomes, patients said that they preferred to be observed for treatment reasons, and not solely for the possibility of negative treatment outcomes.
What is the survival rate for head neoplasms?
Survival for [brain tumor](https://www.withpower.com/clinical-trials/brain-tumor)s has improved over past decades, mostly owing to increased survival among children who have been treated with intensive combined modality therapy. In addition, survival among adults with brain tumors has improved after the introduction of radiotherapy for cranial tumors, which have previously been treated with surgery.
How quickly does head neoplasms spread?
In our population of children and adolescents, the vast majority showed no signs of intracranial disease at presentation. In the very early stages of childhood, children showed no sign of disease dissemination even after irradiation to the brain.
Have there been other clinical trials involving patient observation?
Until this report, the only published trials with regard to patient observation lasted three weeks and the results were very positive. However, in order to assure that these studies were not flawed, it is important to have appropriate clinical data and rigorous research designs. To date, little such data exist for patient observation. Findings from a recent study reported in this report demonstrate the importance of such data.
What does patient observation usually treat?
No consensus exists between experts regarding the best management strategy for paediatric and young adult brain tumours. There is little evidence on the effect of patient observation on survival or progression to more invasive and/or metastatic tumour types. What is known is that patient observation is safe for children and young adults with low-grade brain tumours. Although the quality of study evidence on the benefits and risks of the different management strategies is varied, there is some consensus that it may not be appropriate to use observational management as a 'first line' approach for children with most types of brain tumour.