CLINICAL TRIAL

Patient Observation for Head Neoplasms

Grade III
High Risk
Metastatic
Recruiting · 18+ · All Sexes · Rochester, MN

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.

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About the trial for Head Neoplasms

Eligible Conditions
Head and Neck Neoplasms · Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 · Head and Neck Carcinoma of Unknown Primary · Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 · Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 · Carcinoma · Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 · Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 · Oropharyngeal 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Questionnaire Administration
OTHER
Medical Chart Review
OTHER
Patient Observation
OTHER
Quality-of-Life Assessment
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients must meet criteria for IMPT treatment for oropharyngeal cancer. show original
If IMPT is declined by patient's insurance, they can be treated with standard of care IMRT using the same applicable standard of care procedures outlined in the procedures manual. show original
Meet criteria for adjuvant chemotherapy (if applicable)
You have squamous cell carcinoma of the cervix as defined by histological examination of the cervix. show original
You have lymph node size greater than 3 cm. show original
>= 2 positive lymph nodes
Presence of extracapsular extension. show original
> 1 nodal level involved
Absence of distant metastases on standard diagnostic workup, prior to registration (chest computed tomography [CT], chest x-ray [CXR], or positron emission tomography [PET]/CT)
Able to undergo pre-operative Q-clear series PET/CT head/neck for diagnostic workup of occult primary and nodal disease
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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).

Incidence of acute grade 3 or higher functional mucosal adverse events
UP TO 1 MONTH POST RADIATION THERAPY (XRT)
Will characterize the acute grade 3 or higher functional mucosal adverse events (up to 1 month post-XRT) associated with mucosal sparing.
UP TO 1 MONTH POST RADIATION THERAPY (XRT)
Incidence of acute adverse events
UP TO 1 MONTH POST-XRT
The maximum grade for each type of acute adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns, especially focusing on grade 3+ adverse events, regardless of attribution to the study treatment.
UP TO 1 MONTH POST-XRT
Incidence of late adverse events
UP TO 2 YEARS POST-XRT
The maximum grade for each type of adverse event will be recorded for each patient for up to 2 years post-treatment, and frequency tables will be reviewed to determine patterns, especially focusing on grade 3+ non-hematologic adverse events, regardless of attribution to the study treatment. Hematologic adverse events will not be followed closely long-term given that adjuvant treatment is only given for 1 month.
UP TO 2 YEARS POST-XRT
Distant metastasis rates
UP TO 2 YEARS
UP TO 2 YEARS
Primary local recurrence
AT 2 YEARS
Will be estimated by counting up the number of patients with an occult primary tumor within the pharyngeal axis or nodal recurrence in untreated neck and dividing by the total number of eligible patients.
AT 2 YEARS
Recurrence-free survival (RFS)
FROM REGISTRATION TO THE FIRST OF EITHER DISEASE RECURRENCE, DELAYED LYMPH NODE METASTASIS IN AN UNTREATED NECK (CONTRALATERAL), DEVELOPMENT OF DISTANT METASTATIC DISEASE, OR DEATH, ASSESSED UP TO 5 YEARS
The distribution of RFS will be estimated using the method of Kaplan-Meier.
FROM REGISTRATION TO THE FIRST OF EITHER DISEASE RECURRENCE, DELAYED LYMPH NODE METASTASIS IN AN UNTREATED NECK (CONTRALATERAL), DEVELOPMENT OF DISTANT METASTATIC DISEASE, OR DEATH, ASSESSED UP TO 5 YEARS
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Patient Q & A Section

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

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.

Anonymous Patient Answer

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).

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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