CLINICAL TRIAL

Intensity-Modulated Radiation Therapy for Head Neoplasms

Metastatic
Stage III
Recruiting · 18+ · All Sexes · Rochester, MN

Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients With Stage III-IVB Oropharyngeal Cancer

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About the trial for Head Neoplasms

Eligible Conditions
Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7 · Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7 · Squamous Cell Carcinoma of Head and Neck · Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 · Head and Neck Neoplasms · Carcinoma · Carcinoma, Squamous Cell · Oropharyngeal Neoplasms

Treatment Groups

This trial involves 2 different treatments. Intensity-Modulated Radiation Therapy is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Experimental Group 1
Intensity-Modulated Radiation Therapy
RADIATION
+
Photon Beam Radiation Therapy
RADIATION
+
Quality-of-Life Assessment
OTHER
+
Laboratory Biomarker Analysis
OTHER
Experimental Group 2
Intensity-Modulated Radiation Therapy
RADIATION
+
Quality-of-Life Assessment
OTHER
+
Laboratory Biomarker Analysis
OTHER
+
Proton Beam Radiation Therapy
RADIATION

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-Modulated Radiation Therapy
2009
Completed Phase 3
~1210
Proton Beam Radiation Therapy
2013
Completed Phase 2
~60

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Histologically documented squamous cell carcinoma of the oropharynx (American Joint Committee on Cancer [AJCC] version [v]7 stage III-IV A,B)
Tumor tissue (primary or cervical metastasis) available for human papilloma virus (HPV) and/or p16 (in situ hybridization [ISH], immunohistochemistry [IHC] or genotyping testing); if you do not have enough leftover tumor tissue available, you will have a tumor biopsy for tumor marker testing
Eastern Cooperative Oncology Group (ECOG) performance status = 0, 1, or 2
Negative pregnancy test for women of child bearing potential
Concurrent chemotherapy
Bilateral neck radiation
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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 Intensity-Modulated Radiation Therapy will improve 6 primary outcomes and 2 secondary outcomes in patients with Head Neoplasms. Measurement will happen over the course of 90 days to 2 years post radiation therapy.

Rates and Severity of Late Grade 3-5 Toxicity Between Intensity-Modulated X-Ray Therapy (IMRT) and Intensity-Modulated Proton Beam Therapy (IMPT)
90 DAYS TO 2 YEARS POST RADIATION THERAPY
Cumulative incidence of late onset grade 3+ toxicity anytime during the 2 years following completion of radiation therapy where late onset toxicity occurs 90 days or more following completion of radiation therapy and is graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
90 DAYS TO 2 YEARS POST RADIATION THERAPY
Cumulative incidence of acute grade 3+ toxicity (Phase II)
UP TO 2 YEARS
Will be graded according to the NCI CTCAE version 4.0. The methods described by Gooley will be used to estimate the cumulative incidence of late onset grade 3+ toxicity by 2 years for each treatment arm with death as a competing risk. The methods of Fine and Gray will be used to model the cumulative incidence of late onset grade 3+ toxicity by 2 years as a function of treatment arm and other potential prognostic factors (e.g., HPV/p16 status, use of induction chemotherapy) considering death as a competing risk. Hazard ratios for the prognostic factors from this model with 95% confidence intervals will be estimated.
UP TO 2 YEARS
Cumulative incidence of late onset grade 3+ toxicity anytime (Phase II)
UP TO 2 YEARS
Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The methods described by Gooley will be used to estimate the cumulative incidence of late onset grade 3+ toxicity by 2 years for each treatment arm with death as a competing risk. The methods of Fine and Gray will be used to model the cumulative incidence of late onset grade 3+ toxicity by 2 years as a function of treatment arm and other potential prognostic factors (e.g., human papillomavirus (HPV)/p16 status, use of induction chemotherapy) considering death as a competing risk. Hazard ratios for the prognostic factors from this model with 95% confidence intervals will be estimated.
UP TO 2 YEARS
Progression-free survival (Phase III)
UP TO 3 YEARS
Will be summarized at critical time points using the method of Kaplan-Meier. Kaplan-Meier plots will be used to visualize the time-to-event information by treatment arm, and the trial will be monitored based on results from log-rank tests used to compare treatment arms. Furthermore, Cox proportional hazards regression will be used to assess the time-to-event outcomes while adjusting for covariates of interest.
UP TO 3 YEARS
Progression-Free Survival (PFS) Between Concurrent Chemo-Radiation Strategies with IMRT and IMPT Following the Treatment of Oropharyngeal Tumors
3 YEARS
3 YEARS
Overall survival (OS) (Phase II)
UP TO 5 YEARS
Stratified by treatment arm and estimated using the product limit estimator of Kaplan and Meier. Cox proportional hazards regression will be used to model OS as a function of potential prognostic factors. Hazard ratios for the prognostic factors from this model will be estimated with 95% confidence intervals.
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.

What causes head neoplasms?

The most frequent etiology of head neoplasms is noncancerous. Brain tumors are found more frequently among older adults than younger children, and the elderly group has the highest risk of cancer. Other age groups have a lower probability of cancer.

Anonymous Patient Answer

What is head neoplasms?

The prevalence of CNS-HNs appears to be between 4.3 and 8.1 per million per year in different geographical regions of the world, and with increasing age the prevalence increases. Most of the data for North America was collected in Toronto where neurosurgical oncology residency programs are established and where there was a higher incidence of patients with head or CNS tumors. We believe there is a regional variation not because of demographic but because patients of different risk factors are managed differently. Neurosurgical oncology training programs need a better understanding of the epidemiology of CNS-HNs and greater participation of primary care in the diagnosis and management of these neoplasms.

Anonymous Patient Answer

Can head neoplasms be cured?

For recurrent or metastatic head neoplasms, the treatment protocol is basically the same as that for newly diagnosed tumors. Postoperative local irradiation or chemotherapy with temozolomide can significantly reduce the tumor growth. Intratumoral chemotherapy can also be employed to stop tumor growth in cases of the residual tumors or in case of recurred or metastatic tumors with a relatively better response to chemotherapy. Radiation therapy in the combination with chemotherapy should be considered for advanced or recurrent squamous cell carcinoma or mucoepidermoid carcinoma in an attempt to improve the local control rate and the probability of local remission.

Anonymous Patient Answer

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

Most head neoplasms are related to tobacco use, with a small number of head neoplasms being associated with alcohol. These data provide a basis to evaluate the risk of cancer of the head in smokers with alcohol consumption. A randomized clinical trial is therefore warranted to assess the optimal approach to prevention of head neoplasms in the U.S. population.

Anonymous Patient Answer

What are common treatments for head neoplasms?

The most common treatment for head neoplasms is surgical resection of the tumor. Other treatments include embolization of tumors, radiation therapy (for prophylactic or adjuvant treatment of brain tumors, such cancer being the most common type of cancer), chemotherapy and anti-angiogenic drugs. Chemotherapy is often more effective than radiation treatment, as radiation doesn't penetrate to the tumors within the brain.

Anonymous Patient Answer

What are the signs of head neoplasms?

Symptoms of head neoplasms can be divided into those due to mass effect and compression by brain tissue and those caused by systemic effects. Signs and symptoms of brain cancer including headache, dizziness, visual disturbances, seizures and weakness can all be secondary to various causes. The diagnosis of brain cancer can be complicated by other neurological conditions. A history of seizures, head trauma or recent head surgery are highly suggestive, and other neurological conditions should be considered. The examination may identify symptoms attributable to compression of the cranial nerves.

Anonymous Patient Answer

How serious can head neoplasms be?

Head and neck cancer presents with higher mortality rates than other cancers, and the five-year survival decreases gradually every year. The survival rate also differs based on the nature and location of the tumor and its stage. The location, size, and type of the head and neck cancer are key factors in determining survival. Injuries, mostly from bicycle accidents, threaten the survival of many patients from these tumors, and consequently are a frequent cause of death among them.

Anonymous Patient Answer

Has intensity-modulated radiation therapy proven to be more effective than a placebo?

This meta-analysis indicates that IMRT provides a survival benefit regardless of the degree of risk associated with treatment. As the treatment intensities were comparable and no significant dose variations were found in this meta-analysis, an increase in PBI may be due to the IMRT effect on overall survival (i.e. more patients survive with IMRT than with placebo). The analysis included a wide variance in treatment intensity, making the results not generalizable, but the heterogeneity implies that the PBI effect might be more pronounced for a higher BED.

Anonymous Patient Answer

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

IMRT achieves high local control rates in selected patients. IMRT is frequently used in conjunction with other modes of radiation therapy, including TPA, chemotherapy, surgery, and endovascular treatments when indicated.

Anonymous Patient Answer

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

The authors concluded a statistically significant improvement in QOL was evident and a greater number of respondents felt they could enjoy life and engage in everyday activities when compared with conventional radiation therapy using IMRT.

Anonymous Patient Answer

Is intensity-modulated radiation therapy safe for people?

In the authors' experience, IMSRT is a safe technique for managing head and neck cancer and may prove beneficial in appropriately selected patients, providing the necessary dose of radiation is delivered.

Anonymous Patient Answer

How quickly does head neoplasms spread?

While head neoplasms are not life-threatening, these tumors can recur even when they are removed early. In order to prevent recurrence, it is important to seek treatment early and aggressively. The best way to get rid of the tumor is with surgery or head radiation. This has been in use since before the 20th century. Today, medical devices such as neurofibromatosis gene therapy can help target a mutated tumor that will otherwise keep growing. The future will have more advanced medical technology to help treat head neoplasms. When head neoplasms do form, seek the help of a physician right away.

Anonymous Patient Answer
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