Shortened Adjuvant Radiotherapy for Throat Cancer

Recruiting at 3 trial locations

Overseen By Project Manager

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: T4 disease, Metastatic, 5+ lymph nodes, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

104 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Adjuvant Radiotherapy for throat cancer?

Research suggests that adjuvant radiotherapy (RT) can improve overall survival for patients with lymph node-positive head and neck squamous cell carcinoma, which is similar to throat cancer. This indicates that adjuvant RT might be effective in improving survival outcomes for throat cancer patients as well. ^{1 2 3 4 5}

Is shortened adjuvant radiotherapy for throat cancer safe for humans?

Radiotherapy for head and neck cancers, including throat cancer, can cause side effects like oral mucositis (painful inflammation in the mouth), xerostomia (dry mouth), and severe pain. Careful planning and management are important to reduce these side effects and maintain quality of life during treatment. ^{6 7 8 9 10}

How is the treatment 'Shortened Adjuvant Radiotherapy for Throat Cancer' different from other treatments for this condition?

This treatment is unique because it shortens the overall time of radiation therapy, which can reduce costs and the burden of treatment for patients. It uses a method called hypofractionation, where higher doses of radiation are given over a shorter period, which is different from the traditional longer schedules. ^{1 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

Alexander Lin, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 years old.

Detectable preoperative plasma ctHPVDNA (copy number of more than 200 copies/mL)

Undetectable postoperative plasma ctHPVDNA

Exclusion Criteria

My cancer has spread to distant parts of my body.

I have had radiation therapy to my head or neck.

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adjuvant radiotherapy following TORS and neck dissection, with a reduced dose of 30 Gy over 10 treatments

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

2 years

Treatment Details

Interventions

• Adjuvant Radiotherapy

Trial Overview 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.

Participant Groups

Group I: Shortened Course Adjuvant Radiotherapy Experimental Treatment 1 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.

Adjuvant Radiotherapy is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Radiotherapy for:

• Oropharyngeal squamous cell carcinoma (OPSCC)
• Head and neck cancers

Approved in United States as Radiation Therapy for:

• OPSCC
• Head and neck cancers
• Cervical cancer

Approved in Canada as Radiotherapy for:

• OPSCC
• Head and neck cancers

Approved in Japan as Radiotherapy for:

• OPSCC
• Head and neck cancers

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Findings from Research

Adjuvant radiotherapy (RT) significantly improves 5-year overall survival rates for patients with node-positive head and neck squamous cell carcinoma (HNSCC), with survival rates of 46.3% for surgery plus RT compared to 35.2% for surgery alone.

The benefits of adjuvant RT extend across all nodal stages (N1 to N3), with significant survival improvements noted for various primary tumor sites, indicating that RT is a crucial component of treatment for node-positive HNSCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant radiotherapy and survival for patients with node-positive head and neck cancer: an analysis by primary site and nodal stage. Kao, J., Lavaf, A., Teng, MS., et al.[2019]

In a study of 8795 patients with lymph node-positive head and neck cancer, adjuvant radiotherapy (RT) significantly improved 5-year overall survival rates (43.2% with RT vs 33.4% without RT) and cancer-specific survival (50.9% with RT vs 42.1% without RT).

Adjuvant RT was found to be a significant predictor of improved survival, with a hazards ratio of 0.78, indicating a 22% reduction in the risk of death, highlighting its efficacy in enhancing outcomes for patients with locally advanced squamous cell carcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant radiotherapy improves overall survival for patients with lymph node-positive head and neck squamous cell carcinoma. Lavaf, A., Genden, EM., Cesaretti, JA., et al.[2008]

In a study of 60 patients with oropharyngeal carcinoma, those treated with radical radiotherapy (RT) reported better quality of life outcomes, particularly in speech, compared to those who underwent primary surgery followed by RT, especially in advanced-stage tumors (T3-4).

For patients with advanced-stage disease, radical RT not only showed superior functional outcomes but also suggested that if oncological results are similar, nonsurgical treatment may be the preferred option due to better quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life in patients with oropharynx carcinomas: assessment after accelerated radiotherapy with or without chemotherapy versus radical surgery and postoperative radiotherapy. Allal, AS., Nicoucar, K., Mach, N., et al.[2015]

The timing of radiotherapy (RT) is crucial for patients with advanced head and neck neoplasia, as factors like total treatment time and the length of adjuvant RT can significantly impact clinical outcomes.

Ensuring that there are no interruptions during RT is important, as these timing factors can serve as prognostic indicators, similar to tumor characteristics, affecting the effectiveness of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timing factors as prognostic variables in patients with head and neck squamous cell carcinoma treated with adjuvant radiotherapy: a literature review. Franco, R., Marta, GN.[2020]

A fast-track nutritional intervention for head and neck cancer patients undergoing radiotherapy led to significantly better nutritional status, with a lower prevalence of malnutrition (31.9% in the early group vs 69.5% in the conventional group).

Patients in the early intervention group required less nutritional support and experienced fewer emergency visits and hospitalizations three months after treatment, indicating improved overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early versus conventional nutritional intervention in head and neck cancer patients before radiotherapy: benefits of a fast-track circuit. González-Rodríguez, M., Villar-Taibo, R., Fernández-Pombo, A., et al.[2021]

The study developed the Functional Assessment of Cancer Therapy-Head and Neck Radiotherapy (FACT-HN-RAD) measure, an 8-item tool that effectively captures the most common adverse effects (AEs) of radiation therapy in patients with head and neck squamous cell carcinoma, based on input from 19 patients and 9 radiation oncologists.

Common AEs identified include difficulty swallowing, oral pain, dry mouth, and weight loss, with the measure demonstrating strong face validity among patients, indicating it accurately reflects their experiences during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring Adverse Effects of Radiation Therapy in Patients With Head and Neck Cancer: The FACT-HN-RAD Patient-Reported Outcome Measure. Gharzai, LA., Mierzwa, ML., Peipert, JD., et al.[2023]

Laser phototherapy (LPT) significantly improved the quality of life for a 15-year-old girl undergoing radiotherapy for mucoepidermoid carcinoma, reducing pain and xerostomia after just a few sessions.

After 17 sessions of LPT, all oral mucositis lesions were eliminated, allowing the patient to regain normal oral function and enabling the use of a palatine plate for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in quality of life of an oncological patient by laser phototherapy. Campos, L., Simões, A., Sá, PH., et al.[2015]

Curative radiotherapy for head and neck cancer leads to significant side effects that can greatly affect patients' quality of life and potentially impact the success of their treatment.

Effective management of these adverse effects is crucial to improve patient outcomes and enhance their overall treatment experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing side effects of radiotherapy in head and neck cancer. Mendes, RL., Nutting, CM., Harrington, KJ.[2019]

In a study of 30 patients undergoing radiotherapy for head and neck carcinomas, self-reported pain scores significantly increased from 35 in the first week to 151 by the final week, indicating that pain management is crucial as treatment progresses.

The rise in pain scores, particularly noted in week 3, suggests that radiation-induced inflammation and chemotherapy side effects contribute to increased discomfort, highlighting the need for individualized pain relief strategies and regular treatment reviews to maintain patient comfort and compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective analysis of self-reporting pain scores and pain management during head and neck IMRT radiotherapy: A single institution experience. O'Connor, P., Bisson, J., Asplin, P., et al.[2022]

External beam radiation therapy is a common and effective treatment for head and neck cancers, which account for about 3% of all cancers in the U.S., with 62,000 new cases diagnosed each year.

Due to the complex anatomy of the head and neck region, careful planning of radiation therapy is crucial to minimize side effects on critical structures, and the review provides guidelines for managing these side effects and improving patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Radiation Toxicity in Head and Neck Cancers. Siddiqui, F., Movsas, B.[2018]

In a study of 167 patients with oral cavity and oropharyngeal cancers, those who received whole-neck irradiation (WNI) had a significantly lower rate of cancer recurrence at neck level IV (2%) compared to those who underwent lower-neck-sparing (LNS) irradiation (10%).

The 2-year disease-free survival rates were higher in the WNI group (75%) compared to the LNS group (63%), indicating that WNI may be more effective in preventing recurrence and improving survival in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective analysis of adjuvant radiotherapy in oral cavity or oropharyngeal cancer: Feasibility of omitting lower-neck irradiation. Ho, SY., Kao, WC., Hsiao, SY., et al.[2022]

In a phase 1 study involving 12 patients with resected head and neck squamous cell carcinoma, moderately hypofractionated radiation therapy (RT) was found to be well tolerated, with no dose-limiting toxicities reported.

The study determined that a dose of 44.4 Gy in 12 fractions was the maximum tolerated, but 46.5 Gy in 15 fractions was recommended for further testing due to better tolerability and equivalent effectiveness, indicating a promising approach to reduce treatment time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HYPORT: Phase 1 Study of 3-Week Hypofractionated Postoperative Radiation Therapy for Head and Neck Squamous Cell Carcinoma. Moon, DH., Avkshtol, V., Vo, D., et al.[2023]

In a study of 171 patients with head and neck squamous cell carcinoma treated with concurrent chemoradiotherapy, those with prolonged radiation treatment times (over 7 weeks) faced a significantly higher risk of local tumor failure (hazard ratio of 2.6) and increased mortality (hazard ratio of 1.9).

These findings suggest that prolonged radiation treatment times can negatively impact tumor control and survival in patients receiving concurrent chemotherapy, highlighting the importance of managing symptoms effectively to avoid treatment delays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased local failure risk with prolonged radiation treatment time in head and neck cancer treated with concurrent chemotherapy. Cannon, DM., Geye, HM., Hartig, GK., et al.[2021]

Out of 324 head and neck squamous cell carcinoma patients undergoing radical radiotherapy, 76 (about 23.5%) discontinued treatment without medical authorization, indicating a significant issue with treatment compliance.

Factors contributing to non-compliance included financial difficulties (24.1%), preference for traditional healers (22.2%), and logistical challenges, particularly among patients living more than 100 km from the treatment center, highlighting the need for targeted support for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Factors in Relation with the Non-Compliance to Curative Intent Radiotherapy among Patients of Head and Neck Carcinoma: A Study from the Kumaon Region of India. Pandey, KC., Revannasiddaiah, S., Pant, NK.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adjuvant radiotherapy and survival for patients with node-positive head and neck cancer: an analysis by primary site and nodal stage. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Adjuvant radiotherapy improves overall survival for patients with lymph node-positive head and neck squamous cell carcinoma. [2008]

3. United States pubmed.ncbi.nlm.nih.gov

Quality of life in patients with oropharynx carcinomas: assessment after accelerated radiotherapy with or without chemotherapy versus radical surgery and postoperative radiotherapy. [2015]

4. Brazil pubmed.ncbi.nlm.nih.gov

Timing factors as prognostic variables in patients with head and neck squamous cell carcinoma treated with adjuvant radiotherapy: a literature review. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Early versus conventional nutritional intervention in head and neck cancer patients before radiotherapy: benefits of a fast-track circuit. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Monitoring Adverse Effects of Radiation Therapy in Patients With Head and Neck Cancer: The FACT-HN-RAD Patient-Reported Outcome Measure. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Improvement in quality of life of an oncological patient by laser phototherapy. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Managing side effects of radiotherapy in head and neck cancer. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Retrospective analysis of self-reporting pain scores and pain management during head and neck IMRT radiotherapy: A single institution experience. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Management of Radiation Toxicity in Head and Neck Cancers. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Retrospective analysis of adjuvant radiotherapy in oral cavity or oropharyngeal cancer: Feasibility of omitting lower-neck irradiation. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

HYPORT: Phase 1 Study of 3-Week Hypofractionated Postoperative Radiation Therapy for Head and Neck Squamous Cell Carcinoma. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Increased local failure risk with prolonged radiation treatment time in head and neck cancer treated with concurrent chemotherapy. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Factors in Relation with the Non-Compliance to Curative Intent Radiotherapy among Patients of Head and Neck Carcinoma: A Study from the Kumaon Region of India. [2020]