Adjuvant Radiation Therapy for Cancer of Oropharnyx

Phase-Based Estimates
2
Effectiveness
3
Safety
Mayo Clinic in Arizona, Scottsdale, AZ
Cancer of Oropharnyx+1 More
Adjuvant Radiation Therapy - Radiation
Eligibility
18+
All Sexes
Eligible conditions
Cancer of Oropharnyx

Study Summary

This study is evaluating whether a less intense radiation treatment following surgery might be as effective as the traditional treatment.

See full description

Eligible Conditions

  • Cancer of Oropharnyx
  • Oropharyngeal Neoplasms
  • Oropharynx Cancers

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Adjuvant Radiation Therapy will improve 1 primary outcome and 5 secondary outcomes in patients with Cancer of Oropharnyx. Measurement will happen over the course of 1 year.

1 year
Quality of Life
2 years
Adverse Events Rate
Disease-free survival
Distant failure associated with DART vs standard treatment
Local/regional control
Overall Survival

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Standard of Care Treatment
De-escalated Adjuvant Radiation Therapy

This trial requires 227 total participants across 2 different treatment groups

This trial involves 2 different treatments. Adjuvant Radiation Therapy 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 3 and have had some early promising results.

De-escalated Adjuvant Radiation TherapyDocetaxel 15 mg/m2 days 1, 8 + Radiation Therapy (RT) 30 Gy/1.5 Gy fractions twice daily (b.i.d.) days 1-12 only (intermediate risk) or 36 Gy/1.8 Gy b.i.d. fractions (high risk)
Standard of Care TreatmentRT 60 Gy/2 Gy fractions daily (qday) days 1-40. For high risk, add weekly Cisplatin 40 mg/m2 (Around days 1, 8, 15, 22, 29, 36)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adjuvant Radiation Therapy
2014
Completed Phase 2
~60
Docetaxel
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Closest Location

Mayo Clinic in Arizona - Scottsdale, AZ

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
The patient's tumor is positive for the human papillomavirus (HPV), as shown by immunohistochemical staining for p16. show original
Gross total surgical resection of the primary tumor and unilateral neck dissection within 7 weeks of registration. show original
The lymph node is larger than 3 cm. show original
People who are 18 years or older. show original
An individual with an ECOG PS of 0 or 1 is considered to have a good performance status show original
The patient's chest CT, chest x-ray, and PET/CT all showed no evidence of distant metastases 10 weeks prior to registration. show original
The patient has at least 2 positive lymph nodes. show original
Perineural invasion
Lymphovascular space invasion
The disease is most likely to be T3 or T4. 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.

What are the signs of cancer of oropharnyx?

Add answer

The signs and symptoms of metastatic cancer of the parotid gland are generally similar to those for primary tumor. They include: pain, lymph nodes enlargement, facial swelling, facial paralysis and drooling. It differs from the primary disease: a mass or masses with facial swelling, facial paralysis or both. The treatment is aimed at the symptoms with the use of appropriate analgesics and antimetastatics. The only method is a complete excision of the tumor with the use of facial nerve in the first stage. For the purpose of the diagnosis of extra-parotid lymphadenopathy the ultrasonography is recommended.

Unverified Answer

Can cancer of oropharnyx be cured?

Add answer

Although it is quite possible that cancer of oropharynx can be cured in individual cases, for the population in the whole, cure may not be possible.

Unverified Answer

How many people get cancer of oropharnyx a year in the United States?

Add answer

Each year, around 382,000 Americans are diagnosed with oropharyngeal cancer. This means that there are 1.7 people with cancer of oropharnyx who develop cancer of oropharnyx every day.\n

Unverified Answer

What causes cancer of oropharnyx?

Add answer

There is no evidence for cancer of the oropharnyx having any link to any specific cancer or other risk factors. We could not identify a reason for this but hypothesize it to be because most cancers of the oropharnyx arise from other organs where there is no apparent link to cancer of the oropharnyx. Alternatively, even though cancer of the oropharnyx and oropharyngeal cancer arise from tissue where one of the most common causes of cancer (base lesion) is common, cancer of the oropharnyx may have a different pathogenesis. The rarity of these diseases can also help to explain their scarcity in the literature.

Unverified Answer

What are common treatments for cancer of oropharnyx?

Add answer

There exist limitations to this review which were in part the result of the wide variety of therapies used in clinical practice. The number of well-designed and performed trials of different therapies for the treatment of cancer of oropharyngeal carcinoma is extremely limited. Additional efforts are needed to identify and design more trials so that an overview of therapeutic treatments can be established.

Unverified Answer

What is cancer of oropharnyx?

Add answer

Cancer of oropharynx is an extremely rare tumor that occurs in men. It spreads through the lymphatic system and tends to metastasize to distant organs and cause death due to complications of metastatic disease. Surgery remains the primary treatment option for patients with localized or limited disease and for those with advanced cancer that has infiltrated the lymphatic system.

Unverified Answer

What is adjuvant radiation therapy?

Add answer

In our experience, adjuvant radiotherapy did not cause significant improvements in DMFS or DRS at 10 years and did not affect OS. It was found only a small improvement in LR.

Unverified Answer

What are the chances of developing cancer of oropharnyx?

Add answer

Almost half of patients with cancer of oropharnyx die of cancer. About a fifth of patients have metastatic disease at the time of death, but there is no difference in survival. Findings from a recent study suggests that even in the absence of detectable metastasis, the disease is not a benign one, as even small metastatic burden does not give a good prognosis, as we have seen in metastatic disease.

Unverified Answer

What is the primary cause of cancer of oropharnyx?

Add answer

These data are consistent with the hypothesis that cancer of oropharnyx is not caused primarily by HPV, and highlight the significance of HPV in the development of benign tumors of the OE.

Unverified Answer

What is the latest research for cancer of oropharnyx?

Add answer

With the improvement in the understanding of the genetics, epigenetics and microenvironment, and increasing knowledge of the cellular and molecular mechanisms of tumor formation and progression, we were able to better select the appropriate therapeutic modalities that could contribute to improving patients' overall survival and quality of life.

Unverified Answer

Is adjuvant radiation therapy safe for people?

Add answer

These analyses do not demonstrate a clear benefit of radiation after the initial lumpectomy for patients at high risk of regional recurrence or survival following primary excision of oropharyngeal cancer. Additional high quality evidence is needed on this key question.

Unverified Answer

Who should consider clinical trials for cancer of oropharnyx?

Add answer

Most patients' and patients' parents have some concept of the seriousness of the diagnosis of oropharnyx and of clinical trials. The majority will consider clinical trials, but with a number of misconceptions and some apprehension. Many will not consider clinical studies without direct contact with the hospital for diagnosis and treatment. There is a lack of communication with the hospital's staff and staff, not adequately explained by the hospital's brochures. Many of the misconceptions and fears will need to be corrected for all patients by the hospital staff, explaining the benefits to be gained by the study, as well as to patients receiving the study treatment, not merely to patients in the control group.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Cancer of Oropharnyx by sharing your contact details with the study coordinator.