Radiation Therapy for Head and Neck Cancer

Overseen By Jack Phan, MD, PHD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Breastfeeding, Uncontrolled cardiac, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6-7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two types of radiation therapy to determine which is more effective for recurrent head and neck cancer. Stereotactic body radiation therapy uses precise targeting to treat tumors with fewer doses, aiming to spare healthy tissue. Intensity-modulated radiation therapy employs high-energy rays to shrink tumors. Individuals who have previously had head and neck cancer, received prior radiation, and now have cancer visible on scans might be suitable candidates. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant findings.

Do I need to stop 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?

Research has shown that the treatments in this trial are generally safe for patients with head and neck cancer.

For Intensity-Modulated Radiation Therapy (IMRT), studies indicate it targets tumors with precise high doses and is well-tolerated, with fewer long-term side effects compared to other methods.

Proton Radiation Therapy is also considered safe, typically causing fewer immediate side effects, such as skin irritation and trouble swallowing, than traditional radiation therapies.

Stereotactic Body Radiation Therapy (SBRT) is generally safe, with serious side effects occurring in less than 10% of patients. It is well-tolerated and associated with good survival rates.

Overall, earlier studies have shown positive safety results for these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these radiation therapies for head and neck cancer because they offer more precise targeting of tumors, which can potentially minimize damage to surrounding healthy tissues. Intensity-Modulated Radiation Therapy (IMRT) and Intensity-Modulated Proton Therapy (IMPT) allow for highly controlled radiation doses, which can lead to fewer side effects compared to traditional radiation methods. Meanwhile, Stereotactic Body Radiation Therapy (SBRT) delivers high doses of radiation in just a few sessions, which might result in a quicker treatment process and faster recovery times. These features make these therapies promising options for enhancing treatment efficacy and patient quality of life.

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

This trial will compare different radiation therapies for head and neck cancer. Participants in Group II will receive Intensity-Modulated Radiation Therapy (IMRT). Research shows that IMRT effectively targets tumors with precise, high doses while protecting nearby healthy tissues. Studies have indicated improved survival rates and fewer long-term side effects compared to other methods.

Participants in Group II may also receive Proton Radiation Therapy, which shows promise by reducing complications in healthy tissues while maintaining good cancer control. It has been linked to better survival rates and fewer side effects than traditional radiation therapy.

Participants in Group I will receive Stereotactic Body Radiation Therapy (SBRT), which effectively treats recurring head and neck cancers. SBRT delivers high doses of radiation accurately, destroying tumor cells while minimizing harm to healthy tissue. Studies report good survival rates and low severe toxicity. ^{1 6 7 8 9}

Who Is on the Research Team?

Jack Phan, MD,PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with head and neck cancer that has returned after treatment. They should be in a condition to undergo radiation (ECOG score 0-2), not pregnant, and have had previous radiation of at least 30 Gy. Candidates must not be suitable for surgery, have visible tumors on scans, and limited sites of recurrence.

Inclusion Criteria

I have had head and neck cancer before, received radiation, and it has come back or I have a new one.

I cannot have surgery for my cancer's return due to high risks.

My cancer has returned in 1-3 places, each smaller than 60 cc and all together under 100 cc.

Exclusion Criteria

Patients who are pregnant or breast feeding

My cancer has spread widely in my body.

I have heart problems like heart failure, chest pain, or irregular heartbeat not managed by a pacemaker.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either SBRT every other day for a total of 5 treatments or IMRT/IMPT once daily (Monday-Friday) for up to 30-35 treatments

6-7 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Follow-up at 2-3 months, every 3 months for 1 year, then every 3-4 months for up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Intensity-Modulated Radiation Therapy
• Proton Radiation
• Stereotactic Body Radiation Therapy

Trial Overview

The study compares two advanced types of radiation therapy: Stereotactic Body Radiation Therapy (SBRT) which targets tumors precisely with fewer sessions, and Intensity Modulated Radiation/Proton Therapy (IMRT/PRT) which uses high-energy rays or protons to kill tumor cells.

How Is the Trial Designed?

Group I: Group II (IMRT/IMPT) Experimental Treatment 2 Interventions

Patients undergo IMRT/IMPT once daily (Monday-Friday) for up to 30-35 treatments.

Group II: Group I (SBRT) Experimental Treatment 1 Intervention

Patients undergo SBRT every other day for a total of 5 treatments.

Intensity-Modulated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as IMRT for:

• Oropharyngeal cancer
• Head and neck cancers
• Prostate cancer
• Breast cancer
• Lung cancer

Approved in European Union as IMRT for:

• Oropharyngeal cancer
• Head and neck cancers
• Prostate cancer
• Breast cancer
• Lung cancer

Approved in Canada as IMRT for:

• Oropharyngeal cancer
• Head and neck cancers
• Prostate cancer
• Breast cancer
• Lung cancer

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Intensity-modulated radiation therapy (IMRT) allows for more precise radiation delivery in head and neck cancers, improving local control of tumors while minimizing damage to critical structures like the spine and parotid glands.

IMRT has been shown to preserve salivary function by sparing the parotid glands, although there are ongoing concerns about potential side effects, such as difficulties with swallowing and the risk of secondary cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy for head and neck cancer. Caglar, HB., Allen, AM.[2007]

Intensity modulated proton therapy (IMPT) shows significant dosimetric advantages over traditional intensity modulated radiation therapy (IMRT) for head and neck cancers, particularly in sparing nearby organs like the larynx and salivary glands.

Clinical evidence suggests that IMPT can reduce treatment-related toxicities, such as the need for feeding tubes, indicating its potential benefits in improving patient quality of life during and after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity modulated proton therapy (IMPT) - The future of IMRT for head and neck cancer. Moreno, AC., Frank, SJ., Garden, AS., et al.[2020]

In a study of 47 patients with inoperable skin cancers of the head and neck treated with intensity-modulated proton therapy (IMPT), the overall survival rate at 2 years was high at 87.2%, indicating strong efficacy of this treatment.

IMPT demonstrated a low incidence of adverse events, with no patients experiencing severe side effects (grade 3 or higher) during or shortly after treatment, suggesting it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncologic Outcomes for Head and Neck Skin Malignancies Treated with Protons. Bridhikitti, J., Viehman, JK., Harmsen, WS., et al.[2022]

Proton therapy, particularly intensity-modulated proton therapy (IMPT), offers significant dosimetric advantages over intensity-modulated radiotherapy (IMRT) for head and neck cancers, resulting in reduced doses to critical organs and lower integral doses overall.

Clinical evidence suggests that IMPT leads to fewer toxicities, such as less weight loss and a reduced need for feeding tubes, while patient survival rates are generally comparable to those receiving IMRT, with potential survival benefits noted in specific cases like base of skull or sinonasal cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Proton therapy for head and neck cancers]. Blanchard, P., Frank, SJ.[2022]

Proton radiation therapy, particularly intensity-modulated proton therapy (IMPT), offers better dose localization compared to conventional photon radiation therapy, potentially reducing damage to surrounding healthy tissues in patients with head and neck and skull base tumors.

Initial clinical experiences suggest that IMPT may lead to fewer acute and long-term toxicities, and ongoing multi-institutional trials aim to further establish its effectiveness in treating these complex tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton radiation therapy for head and neck cancer. Chan, AW., Liebsch, NJ.[2018]

Proton therapy for head and neck cancer shows promising results by delivering a lower overall radiation dose while effectively targeting the tumor, which may lead to fewer side effects compared to conventional radiotherapy.

Despite the advantages of proton therapy, conventional radiotherapy remains a strong option due to the extensive research available, suggesting that careful planning and comparison of treatment methods are essential for optimal patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of meta-analysis approach, comparing conventional radiotherapy, and proton beam therapy treating head and neck cancer. Shaikh, F., Sodhi, SK., Kale, LM., et al.[2022]

Intensity-modulated beam radiotherapy (IMRT) allows for precise targeting of head and neck tumors while minimizing radiation exposure to critical structures, resulting in significantly lower acute toxicity compared to conventional radiotherapy methods.

In a review of 28 patients treated with IMRT, the technique demonstrated effective dose optimization, allowing for reduced radiation to the parotid glands and improved treatment outcomes for various head and neck neoplasms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy: first results with this new technology on neoplasms of the head and neck. Kuppersmith, RB., Greco, SC., Teh, BS., et al.[2004]

Intensity modulated proton beam therapy (IMPT) significantly reduces the average radiation dose to tooth-bearing regions in head and neck cancer patients compared to photon-based volumetric modulated arc therapy (VMAT), indicating a safer option for preserving dental health during treatment.

In a study of 121 patients, factors such as oral cavity tumors and advanced T3-T4 tumors were identified as risk factors for receiving a cumulative radiation dose of ≥40 Gy to tooth-bearing areas, which is critical for determining the need for prophylactic dental extractions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Planned dose of intensity modulated proton beam therapy versus volumetric modulated arch therapy to tooth-bearing regions. Alberga, JM., Meijer, J., Raghoebar, GM., et al.[2023]

A meta-analysis of 7 studies with 1049 head and neck cancer patients found that simultaneous integrated boost (SIB)-IMRT and sequential boost (SEQ)-IMRT have comparable clinical outcomes in terms of overall survival, progression-free survival, and locoregional recurrence-free survival.

Both SIB-IMRT and SEQ-IMRT showed similar rates of severe acute adverse effects, suggesting that either technique can be safely used for treatment, with SIB-IMRT potentially offering more convenience due to a shorter treatment course.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of clinical outcomes between simultaneous integrated boost (SIB) versus sequential boost (SEQ) intensity modulated radiation therapy (IMRT) for head and neck cancer: A meta-analysis. Jiang, L., Zhang, Y., Yang, Z., et al.[2021]

Intensity-modulated radiation therapy (IMRT) is effective for treating head and neck cancers, as it delivers precise radiation doses to tumors while minimizing exposure to surrounding healthy tissues.

The ability of IMRT to escalate doses safely is particularly beneficial in head and neck cancer treatment, and ongoing studies are examining its long-term clinical outcomes and potential toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy. Lee, NY., Terezakis, SA.[2022]

A study of 106 patients with head and neck squamous cell carcinoma (HNSCC) showed that simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT) is effective, achieving 3-year loco-regional control rates of 78% for postoperative patients and 64% for those receiving definitive treatment.

Despite some acute and late toxicities, including dysphagia and xerostomia, SIB IMRT was found to be safe, allowing for different dose levels to be delivered within a single treatment session without increasing overall toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcome and toxicity after simultaneous integrated boost IMRT in head and neck squamous cell cancer patients. Dragan, T., Beauvois, S., Moreau, M., et al.[2020]

In a study of 20 patients with locally advanced head and neck cancers, SIB-IMRT was found to be a safe treatment option, with 65% experiencing Grade III mucositis but no cases of Grade III dermatitis.

The treatment showed promising efficacy, with a projected 2-year overall survival rate of 95%, indicating strong tumor control and the potential for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary results of SIB-IMRT in head and neck cancers: report from a regional cancer center in northern India. Chakraborty, S., Ghoshal, S., Patil, VM., et al.[2009]

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