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

Trial Summary

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.

What data supports the effectiveness of this treatment for head and neck cancer?

Research shows that accelerated radiotherapy, often combined with chemotherapy, is effective for treating advanced head and neck cancers. External beam radiotherapy is a recognized option to improve outcomes after surgery, suggesting its potential effectiveness in this context. ^{1 2 3 4 5}

Is radiotherapy for head and neck cancer generally safe for humans?

Radiotherapy, including proton therapy, is generally considered safe for treating head and neck cancer, but it can have side effects like osteoradionecrosis (bone damage due to radiation). Ongoing studies focus on reducing long-term side effects and improving patient quality of life. ^{6 7 8 9 10}

How does the radiotherapy treatment for head and neck cancer differ from other treatments?

This treatment uses a unique approach by offering two different methods of delivering radiotherapy: a single integrated boost and a two-phase treatment. These methods focus on precisely targeting the cancerous area, potentially improving effectiveness and reducing side effects compared to standard concurrent chemo-radiotherapy, which combines chemotherapy and radiotherapy. ^{2 11 12 13 14}

What is the purpose of this trial?

This is a single centre prospective exploratory study of effects of radiation therapy on biomarker development in patients with newly diagnosed (head and neck squamous cell carcinoma) HNSCC receiving curative therapy. This research is part 2 of the HN-BIO study.

Eligibility Criteria

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 able to get out of my bed or chair and move around.

Exclusion Criteria

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

My doctor thinks my overall health makes me unsuitable for this study.

Contra-indication for serial MRI scans

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. 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]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Cost effectiveness of cetuximab concurrent with radiotherapy for patients with locally advanced head and neck cancer in Taiwan: a decision-tree analysis. [2021]

3. France pubmed.ncbi.nlm.nih.gov

[Post-operative radiochemotherapy of the head and neck: Towards new standards?]. [2010]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

A phase I report of paclitaxel dose escalation combined with a fixed dose of carboplatin in the treatment of head and neck carcinoma. [2015]

6. China pubmed.ncbi.nlm.nih.gov

A cross-sectional analysis of registered clinical trials on the use of particle beam radiation therapy in head and neck cancers. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Hitting the Target: Developing High-quality Evidence for Proton Beam Therapy Through Randomised Controlled Trials. [2023]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Effectiveness of radiotherapy for head and neck skin cancers: a single-institution study. [2020]

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

Primary site as predictive factor of local control in advanced head and neck tumors treated by concomitant boost accelerated radiotherapy. [2022]

10. England pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of osteoradionecrosis following proton therapy in patients with head and neck cancer. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Radiotherapy in head and neck cancer management: United Kingdom National Multidisciplinary Guidelines. [2022]

12. France pubmed.ncbi.nlm.nih.gov

Management of head and neck carcinomas with synchronous or metachronous oligometastatic disease: Role of locoregional radiotherapy and metastasis-directed radiotherapy. [2023]

13. England pubmed.ncbi.nlm.nih.gov

A randomized phase II study comparing sequential versus simultaneous chemo-radiotherapy in patients with unresectable locally advanced squamous cell cancer of the head and neck. [2020]

14. Kuwait pubmed.ncbi.nlm.nih.gov

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