Radiotherapy for Head and Neck Cancer

(HN-Bio 02 Trial)

Recruiting at 1 trial location

Overseen By Andrew McPartlin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Systemic disease, Previous tumor, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 7 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how radiation therapy affects certain biological markers in people with newly diagnosed head and neck cancer. The researchers compare two radiation delivery methods: one with a single integrated boost and another with a two-phase treatment. They aim to improve understanding of how these treatments influence the cancer and its environment. This trial suits individuals with head and neck squamous cell carcinoma, particularly if the primary or nodal disease exceeds 3 cm and they are planned for curative treatment. Participants should be able to undergo MRI scans and remain comfortable lying on their back for an hour. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could shape future treatment strategies.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that both types of radiotherapy used in this trial are generally safe. Research indicates that single integrated boost radiotherapy is well-tolerated, even when combined with other treatments. Although some patients may experience long-term side effects, it remains a viable option for those unable to undergo more intense treatments.

The two-phase radiotherapy approach has also proven effective and safe. One study showed it provided good cancer control in the treated area for most patients. While side effects can occur, they are often manageable.

Both treatments are standard practices, commonly used and trusted in treating head and neck cancer. Overall, evidence suggests these radiotherapy treatments are safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these radiotherapy techniques for head and neck cancer because they offer flexibility and precision in targeting tumors. The Integrated Boost Radiotherapy approach delivers a high dose of radiation to the tumor while simultaneously treating surrounding areas, potentially enhancing effectiveness and minimizing damage to healthy tissue. The Two Phase Radiotherapy method introduces a delayed treatment to the nodal regions, which might help in better managing cancer spread with fewer side effects. Both methods aim to refine current radiotherapy practices, potentially leading to improved patient outcomes.

What evidence suggests that this trial's radiotherapy treatments could be effective for head and neck cancer?

Research has shown that external beam radiotherapy effectively treats head and neck squamous cell carcinoma (HNSCC). In this trial, participants will receive one of two treatment methods: a single integrated boost or a two-phase approach. Studies indicate that the single integrated boost method can achieve response rates of 70–90%. This method precisely targets cancer cells while protecting healthy tissues. Meanwhile, the two-phase treatment demonstrated excellent local control in 97% of patients. Both methods hold significant potential to improve survival and manage the tumor, making them reliable options for treating HNSCC. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with newly diagnosed head and neck squamous cell carcinoma (HNSCC) who are about to receive curative radiation therapy. Specific eligibility criteria details were not provided, so it's best to contact the study organizers for more information.

Inclusion Criteria

I can lie on my back comfortably for an hour.

My cancer is a type of squamous cell carcinoma located in the head or neck.

I am willing to have multiple MRI scans.

Exclusion Criteria

My blood does not clot properly and it cannot be corrected.

Pregnancy

History of gadolinium contrast allergy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a baseline fMRI scan and biopsy of the primary tumor and/or lymph node

1 week

1 visit (in-person)

Treatment

Participants receive radiotherapy with either integrated boost or two-phase treatment, including fMRI scans and biopsies in weeks 2 and 4

7 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Standard of care external beam radiotherapy (single integrated boost)
• Standard of care external beam radiotherapy (two-phase treatment)

Trial Overview The study explores how standard external beam radiotherapy affects biomarker development in HNSCC patients. It compares two methods: a single integrated boost versus a two-phase treatment approach.

How Is the Trial Designed?

Group I: Arm 1: Integrated Boost Radiotherapy Active Control 1 Intervention

External beam radiotherapy 70Gy in 35 fractions to head and neck tumour and 56 Gy in 35 fraction to elective nodal regions. This will be given as single integrated boost or two-phase treatment at clinician discretion.

Group II: Arm 2: Two Phase Radiotherapy Active Control 1 Intervention

Standard of care external beam radiotherapy 70 Gy in 35 fractions to head and neck with delayed 40 Gy in 20 fractions to elective nodal regions. This will be given as reversed two-phase treatment.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Concurrent chemo-radiotherapy is the standard treatment for patients with locally advanced head and neck cancers, providing effective care for both surgically operated and non-surgically operable patients.

Weekly carboplatin can be safely and effectively used instead of the standard every-three-weeks cisplatin regimen during concurrent chemo-radiotherapy, resulting in fewer side effects while maintaining similar efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of concurrent chemo-radiotherapy in patients with head and neck cancers: a review. Al-Sarraf, MD.[2012]

Proton therapy (PT) for oropharyngeal carcinoma appears to improve quality of life (QOL) and patient-reported outcomes (PROs) compared to traditional photon-based therapy, particularly in areas like xerostomia (dry mouth) and appetite, based on a review of seven studies.

While PT shows benefits in reducing certain side effects, some issues like sexual symptoms did not improve as much, and overall, QOL and PROs did not fully return to baseline levels after treatment, indicating the need for further research on long-term effects and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Life and Patient-Reported Outcomes Following Proton Therapy for Oropharyngeal Carcinoma: A Systematic Review. Yahya, N., Manan, HA.[2023]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6716705/

PMC - PubMed Central The IMRT technique is characterized by a highly conformal dose distribution to targets, whereas a constraint dose to organs at risk (OARs).

2. sciencedirect.com sciencedirect.com/science/article/pii/S245210942500185X

Efficacy and Toxicity of Simultaneous modulated ... After a median follow-up of 33 months, the median overall survival was 16.7 months, and the three-year overall survival rate was 44.4%. Majority ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO-24-02194

The UPGRADE-RT Multicenter Randomized Controlled Trial The primary outcome was normalcy of diet score at 1 year. The secondary outcome was recurrence in electively irradiated nodes at 2 years in the ...

4. journals.lww.com journals.lww.com/cancerjournal/fulltext/2022/18060/long_term_outcome_and_late_toxicity_of_sib_imrt_in.2.aspx

Long term outcome and late toxicity Of SIB-IMRT in... Efficacy and late toxicity of IMRT-SIB observed in our study suggest it as a suitable treatment option for patients who are not fit for chemoradiation.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11674243/

Emerging Radiotherapy Technologies for Head and Neck ... Large retrospective series have demonstrated response rates up to 70–90% [15,16]. In a large series of 166 patients who received previous ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1507136720300626

Simultaneous Integrated Boost Radiotherapy in ... SIB-IMRT is safeand can be used with concomitant chemotherapy/biotherapy in real-life daily clinical practice. SIB-IMRT alone is a valid alternative in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12316137/

Clinical Benefit and Safety of Reduced Elective Dose in ... Definitive radiotherapy (RT) for head and neck cancer (HNC) has significant long-term toxicity with elective neck irradiation (ENI) as a major ...

8. ascopubs.org ascopubs.org/doi/pdf/10.1200/JCO-24-02194

Clinical Benefit and Safety of Reduced Elective Dose in The secondary outcome was recurrence in electively irradiated LNs at 2 years. The radiation treatment plan and imaging of all regional.