What side effects are associated with this type of intervention?

Common treatments for Squamous Cell Carcinoma (SCC) include radiation therapy, chemotherapy, and chemoradiation. Reduced radiation dose regimens aim to minimize side effects while maintaining treatment efficacy. Known side effects of standard radiation therapy include xerostomia (dry mouth), dysphagia (difficulty swallowing), and long-term toxicities such as fibrosis and lymphedema. Chemotherapy, particularly with agents like cisplatin, can cause nephrotoxicity, ototoxicity (hearing loss), and neurotoxicity. Reduced radiation dose regimens have shown to decrease the incidence of severe late toxicities, such as grade ≥3 adverse events, and improve quality of life outcomes, including better swallowing function and less need for gastrostomy tubes.

What prior FDA approvals exist?

FDA-approved treatments for Squamous Cell Carcinoma (SCC) include cetuximab, which has been shown to improve overall survival when combined with chemotherapy. Pembrolizumab and nivolumab, both PD-1 inhibitors, are also approved for patients previously treated with platinum-based chemotherapy. These immunotherapies have demonstrated significant clinical activity in recurrent or metastatic SCC. Additionally, trials have explored dose-reduced radiation therapy, such as the phase III trial comparing standard-dose and dose-reduced adjuvant radiation in HPV-associated oropharyngeal cancer, showing promising results in reducing long-term toxicity while maintaining efficacy.

What other types of research exist?

Promising novel alternatives to reduced radiation dose for Squamous Cell Carcinoma patients include: 1) Image-Guided Intensity-Modulated Radiation Therapy (IMRT) which allows for precise targeting of tumors while sparing healthy tissue, 2) The use of biomarkers to predict and monitor toxicity, enabling personalized treatment adjustments, 3) Combining radiation therapy with systemic therapies such as chemotherapy or immunotherapy to enhance efficacy and potentially allow for lower radiation doses, and 4) Emerging technologies like stereotactic radiosurgery (SRS) and proton therapy which offer targeted treatment with reduced side effects.

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Radiation Therapy

Shortened Adjuvant Radiotherapy for Throat Cancer

Phase 2

Recruiting

Led By Alexander Lin, MD

Research Sponsored by Abramson Cancer Center at Penn Medicine

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 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a lower dose of radiation therapy for throat cancer patients who have responded well to surgery. It aims to reduce side effects while still targeting any remaining cancer cells, and avoids unnecessary radiation in some areas.

Who is the study for?

This trial is for adults over 18 with a specific throat cancer (p16+ oropharyngeal squamous cell carcinoma) who've had surgery and some lymph node involvement but no distant spread of the disease. They must have good performance status, which means they can carry out daily activities without significant assistance.

What is being tested?

The study tests if it's safe to give less radiation after transoral robotic surgery (TORS) and neck dissection in patients with certain throat cancers. It also explores whether avoiding radiation to the area where the tumor was removed is effective.

What are the potential side effects?

Adjuvant radiotherapy may cause skin redness, sore mouth or throat, difficulty swallowing, dry mouth, taste changes, fatigue, and in rare cases more serious effects like damage to surrounding organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Locoregional control

Secondary study objectives

Dysphagia, as measured by patient-reported outcome

Metastasis-free survival

Overall survival

+2 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: Shortened Course Adjuvant RadiotherapyExperimental Treatment1 Intervention

The volume treated to the regional lymphatics will be according to the characteristics of the primary site and involved lymph nodes. The dose of radiotherapy delivered will be 30 Gy, over the course of 10 treatments (5 daily treatments/week). Treatment of the primary tumor bed will be omitted in appropriate patients, as per the initial TORS de-intensification protocol. In patients requiring treatment of the primary site, reduced dose (30 Gy) will be delivered.

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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 and chemoradiotherapy. Radiation therapy works by damaging the DNA of cancer cells, preventing them from replicating and causing cell death. Chemoradiotherapy combines chemotherapy with radiation, where chemotherapy enhances the cancer cells' sensitivity to radiation, improving treatment efficacy. Reducing radiation doses, as studied in some trials, aims to minimize side effects while maintaining the treatment's effectiveness, which is important for improving the quality of life for SCC patients.

Defining the role of high-dose radiation in oligometastatic & oligorecurrent cervical cancer.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.Optimisation of chemotherapy and radiotherapy for untreated Hodgkin lymphoma patients with respect to second malignant neoplasms, overall and progression-free survival: individual participant data analysis.