CLINICAL TRIAL

Adjuvant hypofractionation for Oral Squamous Cell Carcinoma

Recruiting · 65+ · All Sexes · New York, NY

Hypofractionated Radiotherapy in Elderly Patients With Head & Neck Squamous Cell Carcinoma

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About the trial for Oral Squamous Cell Carcinoma

Eligible Conditions
Carcinoma · Squamous Cell Carcinoma Head and Neck Cancer (HNSCC) · Carcinoma, Squamous Cell · Squamous Cell Carcinoma of Head and Neck

Treatment Groups

This trial involves 2 different treatments. Adjuvant Hypofractionation is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Definitive Hypofractionation
RADIATION
Experimental Group 2
Adjuvant hypofractionation
RADIATION

Eligibility

This trial is for patients born any sex aged 65 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:
No previous RT or chemotherapy for HNSCC is allowed at time of study entry.
All stages (according to National Comprehensive Cancer Network 8th edition for head and neck cancers), except stage IVC5
Life expectancy > 12 weeks.
Age ≥ 70 years.
Anyone eligible for definitive or adjuvant based RT therapy
Non-concurrent chemotherapy
Adjuvant therapy when histopathological factors (advanced T category, nodal disease, lymphovascular or perineural invasion, high-grade, or positive margins)
Anyone being treated with curative intent
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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 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 3 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 Adjuvant hypofractionation will improve 1 primary outcome and 4 secondary outcomes in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of 6 months.

Number of participants with Locoregional Control (LRC)
6 MONTHS
For the adjuvant cohort: LRC will be defined as absence of disease on imaging or no clinical evidence of disease. For the definitive cohort: LRC will be defined as regression in size or disappearance of primary tumor and/or lymph nodes on imaging or clinical examination.
FACT-H&N questionnaire
UP TO 1 YEAR
Foundation for the Accreditation of Cellular Therapy-Head and Neck (FACT-H&N) questionnaire, 38-item instrument. Full scale from 0 to 144, with higher score indicating better quality of life.
Overall Survival (OS) rate
1 YEAR
1 year overall survival of patients as defined by completion of treatment until death at 1 year.
Disease Free Survival (DFS) rate
1 YEAR
1 year disease free survival of patients as defined by completion of treatment until disease recurrence locally, regionally and/or distantly or until the time of death due to disease assessed via PET scan and physical exam.
University of Washington Quality of Life Questionnaire (UW-QOL)
UP TO 3 YEARS
University of Washington Quality of Life Questionnaire (UW-QOL) full scale from 0 to 100, with higher score indicating poorer health outcomes.

Who is running the study

Principal Investigator
R. L. B.
Prof. Richard L. Bakst, Associate Professor, Radiation Oncology
Icahn School of Medicine at Mount Sinai

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 oral squamous cell carcinoma a year in the United States?

The US population is at risk for OSCC with a rate of approximately 1.75 per 100,000. In this population, the use of tobacco and alcohol are the main risk factors for OSCC. These data should help establish the optimum screening and prevention strategies in the United States.

Anonymous Patient Answer

What is oral squamous cell carcinoma?

Oral cancers can occur on the cheeks, gums, tongue and floor of the mouth. Patients with early oral cancers, people who have or have had oral squamous cell carcinoma and patients with gingival cancer should be followed up frequently. In addition, oral squamous cell carcinomas are often difficult to detect and there are many unknown risk factors for early detection.\n

Anonymous Patient Answer

Can oral squamous cell carcinoma be cured?

A cure for oral cancer does not exist. The risk of long-term survival for a patient will depend primarily on the stage in which the cancer is diagnosed. The risk is also affected by factors such as the individual's psychological stability, oral and general health, and the treatment received. Good dental care can help reduce the incidence of oral cancer and therefore the risk to the patient and the patient's family.

Anonymous Patient Answer

What causes oral squamous cell carcinoma?

Results from a recent clinical trial suggests that the risk of OSCC associated with smoking may be related to alterations in both local stomatal density and stomatal conductance. The high prevalence of smoking and OSCC suggests that local stomatal factors may act as carcinogens. The use and duration of alcohol consumption is also associated with an increased risk of OSCC.

Anonymous Patient Answer

What are common treatments for oral squamous cell carcinoma?

Common treatments for OSCC include radiotherapy, chemotherapy, and surgery. Laryngeal/uvula cancer can typically be managed by surgery, while tongue/oropharyngeal cancer tends to be managed through radiation. If metastasis to the liver has occurred, surgery is often the preferred treatment, because it can provide pain relief and increase survival time for the patients and their families.

Anonymous Patient Answer

What are the signs of oral squamous cell carcinoma?

Lesions may present as oral ulceration and erythematous changes in the gums, or as a mass of the floor of the mouth or cheeks. The most common site of tumors is the tongue (30%). Lesions in the gums and floor of the mouth are more likely to be squamous cell carcinoma than benign lesions. It is not uncommon for oral cancers to be present before lesions become detectable. Screening the oral cavity is considered essential for early detection of oral cancers. Cancerous lesions on the hard palate may be a good candidate to implement early oral cancer screening.

Anonymous Patient Answer

Have there been any new discoveries for treating oral squamous cell carcinoma?

There are no conclusive studies that can be used to support the use of radiotherapy for treating oral cancer. Although chemotherapy has significant efficacy in treating oral squamous cell carcinoma, there are still some cases where relapse and cancer death occurred in the oral cavity.

Anonymous Patient Answer

What is the latest research for oral squamous cell carcinoma?

[Pit and fissure lesions] had an overall 5-year survival of 71%-82%.[Slightly raised lesions, erythroplasty, and T4 lesions had an overall 5-year survival of 69%-72%; while erythroplasty, T4 and poorly differentiated lesions had an overall 5-year survival of 56%-64%.[Small ulcers or inverted papilloma] had an overall 5-year survival of 79-82%; while inverted papilloma and well differentiated lesions had an overall 5-year survival of 69%-82%.

Anonymous Patient Answer

What does adjuvant hypofractionation usually treat?

Adjuvant hypofractionation in oropharyngeal and non‐oropharyngeal cancer patients with localized disease and a 3-grade tumor with good histologic margins should be offered before radiation therapy without delay as part of a multidisciplinary management approach to patients willing to receive radical radiation therapy after surgery. There is no clear evidence that hypofractionation can prolong survival.

Anonymous Patient Answer

Does adjuvant hypofractionation improve quality of life for those with oral squamous cell carcinoma?

The present study revealed that adjuvant radiation treatment with fractionated-dose was associated with a non-significant decrease in physical and mental functioning. The treatment-related deterioration of psychosocial parameters, such as body image, was noted. In a recent study, findings imply that quality of life is adversely influenced by adjuvant radiation treatment for OSCC.

Anonymous Patient Answer

What are the chances of developing oral squamous cell carcinoma?

The risk of developing OSCC was higher in males than females. This difference may be attributed to a lower smoking and drinking rates in females and also be associated with a lower diet intake. Larger and longer duration studies are required to fully understand the aetiology and risk factors associated with OSCC. A better dietary questionnaire should be developed to assess dietary habits.

Anonymous Patient Answer

What is the survival rate for oral squamous cell carcinoma?

Overall 5-year survival for patients with all stages is 65.7%. For T1, T2, T3N0, and T3N1 patients, it is 86.3%, 57.1%, 47.6%, and 43.9% respectively. In summary, the overall 5-year survival rate is similar to other cancers (65.7%), however, the 5-year survival is high for patients with all stages compared to OSCC and for patients with early-stage OSCC compared to those who have lymph node involvement.

Anonymous Patient Answer
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