Radiotherapy for Head and Neck Cancer

Recruiting at 2 trial locations

Overseen By Ryan Hughes, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Recurrent cancer, Prior radiotherapy, Metastatic disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: up to 165 days

75 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 Accelerated Radiotherapy for Head and Neck Cancer?

Research shows that accelerated radiotherapy, which shortens the overall treatment time, can increase the effectiveness of radiation in treating head and neck cancers. Studies have found it particularly beneficial for advanced stages of these cancers, as it helps overcome the rapid growth of cancer cells during treatment. ^{1 2 3 4 5}

Is radiotherapy for head and neck cancer safe for humans?

Research shows that accelerated radiotherapy, often combined with chemotherapy, is generally safe for treating head and neck cancer, though it can cause side effects like treatment toxicity and acute side effects. Studies have evaluated its safety in both general and elderly populations, indicating it is a feasible treatment option with manageable side effects. ^{3 6 7 8 9}

How is accelerated radiotherapy different from other treatments for head and neck cancer?

Accelerated radiotherapy is unique because it delivers high doses of radiation in a shorter overall treatment time compared to conventional radiotherapy, which may help control the rapid growth of tumor cells more effectively. This approach can lead to better tumor control and potentially improved survival rates for patients with advanced head and neck cancers. ^{2 3 4 10 11}

What is the purpose of this trial?

The goal of this clinical trial is to determine whether accelerated radiotherapy (involving 6 treatments per week) is better than standard radiotherapy (involving 5 treatments per week) at treating cancer of the head and neck when initiated more than 6 weeks after surgery.

Research Team

Ryan Hughes, M.D.

Principal Investigator

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Eligibility Criteria

This trial is for patients with certain head and neck cancers who've had surgery over 6 weeks ago. It's not specified who can't join, but typically those with poor health or other serious conditions might be excluded.

Inclusion Criteria

I had surgery to remove all visible head and neck cancer.

I am fully active or can carry out light work.

Ability to understand and sign an IRB-approved informed consent document directly, in English or Spanish, and complete study-related forms and activities

Exclusion Criteria

My head or neck cancer has returned after radiation or surgery followed by radiation.

My doctor says I can't have radiation therapy.

I have no active cancer other than in my head or neck.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either accelerated or conventional fractionation radiotherapy

up to 165 days

Daily treatments, Monday-Friday

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 5 years

Regular follow-up visits at 3, 6, 12, and 24 months post RT

Treatment Details

Interventions

• Accelerated Radiotherapy
• Conventional Radiotherapy

Trial Overview The study compares two types of radiotherapy: accelerated (6 treatments/week) versus conventional (5 treatments/week), to see which is more effective for head and neck cancer post-surgery.

Participant Groups

Group I: Accelerated fractionation (6 Fractions) Experimental Treatment 1 Intervention

6 fractions per week, daily treatment plus twice daily treatment for 1 day Monday-Friday; dosage at the discretion of the treating radiation oncologist per standard of care

Group II: Conventional fractionation (5 Fractions) Active Control 1 Intervention

5 fractions per week, daily treatment Monday-Friday; dosage at the discretion of the treating radiation oncologist per standard of care

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Findings from Research

In a study involving 74 patients with Stage III to IV head and neck cancers, a 5-week accelerated radiotherapy schedule showed a 5-year locoregional control rate of 56% and an overall survival rate of 32%, indicating its potential effectiveness.

While the treatment resulted in significant side effects, including severe mucositis in 77% of patients, the rate of late complications was relatively low at 10.5%, suggesting that this accelerated regimen is feasible and may be a viable option for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An original accelerated radiotherapy schedule in stage III to IV head and neck cancers. Results in a multicenter setting. Allal, AS., Monney, M., Rosset, A., et al.[2019]

The study found that tumors in the head and neck region do not show significant differences in their proliferative capacity based on their site of origin, suggesting that treatment strategies may not need to vary by tumor location.

Aneuploid tumors, which have an abnormal number of chromosomes, exhibited a higher proliferative capacity compared to diploid tumors, indicating they may benefit more from accelerated radiotherapy treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proliferative capacity in head and neck cancer. Struikmans, H., Kal, HB., Hordijk, GJ., et al.[2019]

Accelerated chemoradiotherapy with concurrent cisplatin or cetuximab in 43 patients with advanced head-and-neck squamous cell carcinoma resulted in a high complete response rate of 74.4% and good locoregional control rates of 82% at 1, 2, and 5 years.

While the treatment was effective, it did have some side effects, with 30.2% of patients experiencing grade 3 mucositis and 27.9% experiencing grade 2 xerostomia, but overall, the toxicities were considered tolerable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IMRT with simultaneous integrated boost and concurrent chemotherapy for locoregionally advanced squamous cell carcinoma of the head and neck. Montejo, ME., Shrieve, DC., Bentz, BG., et al.[2019]

In a study of 51 patients with locally advanced head and neck cancers, the combination of concomitant boost radiotherapy and chemotherapy showed a complete response rate of 51% and an overall response rate of 75.5%, indicating its efficacy in this patient population.

Despite the treatment's effectiveness, only 55% of patients completed it as planned, with the most common side effect being grade 3 mucositis in 49% of patients, highlighting the need for careful patient selection and management of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated radiotherapy in locally advanced head-neck carcinomas: are concomitant boost and chemotherapy feasible in the routine outpatient-based radiotherapy clinic? Akman, F., Sen, M., Erdag, T., et al.[2007]

The biphasic accelerated radiotherapy regimen for postoperative treatment of advanced head and neck cancers was feasible, with 93% of the 29 enrolled patients completing the treatment without interruptions.

While most patients experienced mucositis, the acute toxicity was considered acceptable, with no severe Grade 5 reactions, indicating that this treatment approach could be safely implemented in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative radiotherapy for head and neck squamous cell carcinomas: feasibility of a biphasic accelerated treatment schedule. Sanguineti, G., Corvo', R., Vitale, V., et al.[2019]

In a phase 3 trial involving 840 patients with locally advanced head and neck cancer, conventional chemoradiotherapy showed the best progression-free survival (PFS) rates compared to accelerated radiotherapy-chemotherapy and very accelerated radiotherapy, indicating its superior efficacy.

Very accelerated radiotherapy was associated with higher rates of severe acute mucosal toxicity, suggesting that while it may be faster, it can lead to more serious side effects compared to conventional treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concomitant chemoradiotherapy versus acceleration of radiotherapy with or without concomitant chemotherapy in locally advanced head and neck carcinoma (GORTEC 99-02): an open-label phase 3 randomised trial. Bourhis, J., Sire, C., Graff, P., et al.[2022]

Accelerated concomitant boost radiotherapy (RT) is feasible for elderly patients (aged 70 and above) with head and neck carcinoma, showing similar treatment completion rates and toxicities compared to younger patients.

Both elderly and younger patients experienced comparable oncologic outcomes, with similar rates of acute reactions and overall survival, suggesting that age alone should not deter the use of aggressive RT in fit older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and early results of accelerated radiotherapy for head and neck carcinoma in the elderly. Allal, AS., Maire, D., Becker, M., et al.[2022]

In a study of 30 patients with locally advanced head and neck cancer, a treatment regimen of accelerated radiation therapy combined with chemotherapy resulted in a high incidence of acute mucositis, increasing from 33.3% in the first week to 93.3% by the end of the fifth week, but showed a decrease to 70% in the sixth week.

The treatment approach demonstrated a significant reduction in complications during the final weeks of therapy, suggesting that the combination of accelerated radiation and chemotherapy with celecoxib may improve tolerance and manage side effects effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concomitant boost chemoradiotherapy in locally advanced head and neck cancer: treatment tolerance and acute side effects. Majdaeen, M., Kazemian, A., Babaei, M., et al.[2015]

The HARDWINS treatment for advanced head and neck cancer, involving radiation dose escalation up to 64Gy, was delivered safely without any grade 4 acute toxicity, although significant grade 3 toxicity was observed, particularly affecting the pharynx and esophagus.

With a 5-year overall survival rate of 65% and a relapse-free rate of 63%, HARDWINS shows promising outcomes as an alternative to chemoradiation, despite a notable incidence of feeding tube dependence in patients receiving the highest radiation dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A dose escalation study of hyperfractionated accelerated radiation delivered with integrated neck surgery (HARDWINS) for the management of advanced head and neck cancer. Waldron, J., Warde, P., Irish, J., et al.[2018]

Hyperfractionated radiation therapy has been shown to improve tumor control in head and neck squamous cell carcinomas, as demonstrated in the EORTC 22791 trial.

Accelerated radiation therapy allows for higher total doses to be delivered in a shorter time, which may be crucial for overcoming rapid tumor cell repopulation during treatment, as supported by recent randomized trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Status of accelerated fractionation radiotherapy in head and neck squamous cell carcinomas. Bourhis, J., Wibault, P., Lusinchi, A., et al.[2019]

A very accelerated radiotherapy regimen (62 Gy in three weeks) was administered to 46 patients with advanced head and neck cancers, resulting in a 2-year survival rate of 49.4% and a loco-regional control rate of 67%, which are better outcomes compared to conventional radiotherapy.

While nearly all patients experienced severe mucositis (grade 3 or 4), the side effects were manageable, and follow-up suggests that late reactions may not differ significantly from those seen with standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Accelerated radiotherapy: initial results in a series of locally very advanced carcinomas of the upper respiratory and digestive tracts]. Dupuis, O., Bourhis, J., Attal, P., et al.[2007]

References

1. Germany pubmed.ncbi.nlm.nih.gov

An original accelerated radiotherapy schedule in stage III to IV head and neck cancers. Results in a multicenter setting. [2019]

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

Proliferative capacity in head and neck cancer. [2019]

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

IMRT with simultaneous integrated boost and concurrent chemotherapy for locoregionally advanced squamous cell carcinoma of the head and neck. [2019]

4. Cyprus pubmed.ncbi.nlm.nih.gov

Accelerated radiotherapy in locally advanced head-neck carcinomas: are concomitant boost and chemotherapy feasible in the routine outpatient-based radiotherapy clinic? [2007]

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

Postoperative radiotherapy for head and neck squamous cell carcinomas: feasibility of a biphasic accelerated treatment schedule. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Concomitant chemoradiotherapy versus acceleration of radiotherapy with or without concomitant chemotherapy in locally advanced head and neck carcinoma (GORTEC 99-02): an open-label phase 3 randomised trial. [2022]

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

Feasibility and early results of accelerated radiotherapy for head and neck carcinoma in the elderly. [2022]

8. India pubmed.ncbi.nlm.nih.gov

Concomitant boost chemoradiotherapy in locally advanced head and neck cancer: treatment tolerance and acute side effects. [2015]

9. Ireland pubmed.ncbi.nlm.nih.gov

A dose escalation study of hyperfractionated accelerated radiation delivered with integrated neck surgery (HARDWINS) for the management of advanced head and neck cancer. [2018]

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

Status of accelerated fractionation radiotherapy in head and neck squamous cell carcinomas. [2019]

11. France pubmed.ncbi.nlm.nih.gov

[Accelerated radiotherapy: initial results in a series of locally very advanced carcinomas of the upper respiratory and digestive tracts]. [2007]