What side effects are associated with this type of intervention?

Common treatments for Squamous Cell Carcinoma (SCC) of the head and neck, such as high-energy radiation therapy and chemoradiation, are associated with several side effects. These include acute side effects like mucositis, which can be severe and lead to the need for tube feeding in some patients. Long-term side effects may include ulceration, soft tissue necrosis, fibrosis, dysphagia, and osteonecrosis. De-intensified radiotherapy aims to reduce these toxicities while maintaining treatment efficacy. Studies have shown that reduced-dose radiotherapy can lead to fewer severe adverse events, such as lower rates of severe mucositis and improved overall quality of life, including better swallowing function and less pain.

What prior FDA approvals exist?

The FDA has approved several treatments for Squamous Cell Carcinoma (SCC) that involve high-energy radiation and related drugs. For HPV-associated oropharyngeal SCCs, treatments often include chemoradiation with drugs like cisplatin, which is used concurrently with radiation therapy. Additionally, PD-1 inhibitors such as nivolumab and pembrolizumab have been approved for metastatic or recurrent SCC of the head and neck, particularly for patients who have previously been treated with platinum-based chemotherapy. These treatments aim to enhance the effectiveness of radiation therapy by targeting cancer cells more precisely and reducing long-term toxicity.

What other types of research exist?

Promising novel alternatives to de-intensified radiotherapy for squamous cell carcinoma patients include: 1) Targeted therapies, such as those targeting specific genetic mutations or pathways involved in cancer growth. 2) Immunotherapies, including checkpoint inhibitors that enhance the body's immune response against cancer cells. 3) Advanced surgical techniques, such as transoral robotic surgery (TORS) and transoral laser microsurgery, which aim to minimize damage to surrounding tissues and improve recovery times. These alternatives are being explored to reduce toxicity and improve quality of life while maintaining treatment efficacy.

← Back to Search

Radiation

De-intensified Chemoradiotherapy for Oropharyngeal Cancer (PROTEcT Trial)

N/A

Recruiting

Led By Harvey Quon, MD

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses lower doses of radiation and standard chemotherapy to treat patients with a specific type of throat cancer, aiming to reduce side effects while effectively treating the cancer.

Who is the study for?

Adults with p16+ squamous cell carcinoma of the oropharynx, eligible for curative treatment, can join this trial. They must have certain tumor and nodal stages (T1-T3, N1-N2), good organ function, and an ECOG performance status of 0-2. Smokers and non-smokers are welcome. Those with metastatic disease, prior head and neck cancer/radiation, or who are pregnant cannot participate.

What is being tested?

The PROTEcT study is testing a de-intensified chemoradiotherapy approach for patients with p16+ oropharyngeal cancer. It's a single-arm prospective cohort study across multiple centers aiming to see if reducing radiation volume and dose is effective.

What are the potential side effects?

While specific side effects aren't listed here, de-intensified chemoradiotherapy may generally lead to reduced appetite, mouth sores, dry mouth/throat issues due to radiation; chemotherapy could cause nausea/vomiting, fatigue, hair loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Toxicity Criteria for Adverse Events

Xerostomia

Other study objectives

#1 Quality of life

#2 Quality of life

#3 Quality of life

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: De-intensified chemoradiotherapyExperimental Treatment1 Intervention

Radiotherapy to a dose of 60 Gy to the primary tumour and involved lymph nodes and 54 Gy to subclinical regions at risk in 30 fractions. Reduced volume of elective nodal radiation.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Squamous Cell Carcinoma (SCC) include radiation therapy, chemotherapy, and surgery. Radiation therapy uses high-energy radiation to damage the DNA of cancer cells, preventing them from replicating and leading to cell death. Chemotherapy employs drugs that target rapidly dividing cells, including cancer cells, to halt their growth and induce cell death. Surgery involves the physical removal of the tumor and surrounding affected tissue. Understanding these mechanisms is important for SCC patients as it helps them make informed decisions about their treatment options, especially when considering de-intensified therapies that aim to reduce side effects while maintaining treatment effectiveness.

Defining the role of high-dose radiation in oligometastatic & oligorecurrent cervical cancer.Treatment de-escalation for HPV+ oropharyngeal cancer: A systematic review and meta-analysis.Phase II study of a new multidisciplinary therapy using once every 3 week carboplatin plus dose-dense weekly paclitaxel before and after radical hysterectomy for locally advanced cervical cancer.