Hypofractionated IMRT for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Dominic Moon, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Investigational agents

Disqualifiers: Distant metastasis, High risk factors, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

There is a strong radiobiological and economic rationale for hypofractionated radiation therapy in head and neck cancer. Phase 1 of the trial aims to assess the acute toxicity and tolerability of hypofractionated radiation therapy in the post-operative setting, and to determine the dose/fractionation for Phase 2. Phase 2 aims to establish non-inferiority of swallowing-related quality of life and to assess the toxicity and efficacy of hypofractionated radiation therapy compared to conventionally fractionated radiation therapy in the post-operative setting.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot be on any other investigational agents for the treatment of the cancer under study.

What data supports the effectiveness of the treatment Hypofractionated IMRT for Head and Neck Cancer?

Research shows that Volumetric Modulated Arc Therapy (VMAT), a part of the treatment, can deliver radiation more quickly and comfortably than traditional methods, with similar or better precision and protection of healthy tissues. This suggests that the treatment could be effective and efficient for head and neck cancer. ^{1 2 3 4 5}

Is hypofractionated IMRT safe for head and neck cancer patients?

Hypofractionated IMRT for head and neck cancer has shown limited toxicity, meaning it generally causes fewer harmful side effects compared to older methods. This suggests it is relatively safe for patients. ^{2 3 4 6 7}

How is hypofractionated IMRT different from other treatments for head and neck cancer?

Hypofractionated IMRT for head and neck cancer is unique because it uses fewer, larger doses of radiation compared to traditional methods, potentially reducing treatment time. Additionally, VMAT, a form of IMRT, offers faster delivery and better protection for healthy tissues, improving patient comfort and reducing side effects. ^{1 2 3 4 6}

Research Team

Dominic Moon, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This trial is for adults with stage I-IVB squamous cell carcinoma of the oral cavity or related areas, who've had surgery but still have intermediate risk factors. They must be in fair health, able to consent, and use birth control if needed. Excluded are those with distant cancer spread, prior radiation in the area, severe illnesses that affect study compliance, pregnant/nursing women, high-risk surgical outcomes needing chemo, certain immune conditions or other cancers.

Inclusion Criteria

I can take care of myself and am up and about more than half of the day.

I am 18 years old or older.

I agree to use birth control during the study.

Exclusion Criteria

My cancer is a stage I or II squamous cell carcinoma of the glottis.

My cancer has spread to distant parts of my body.

I need chemotherapy along with surgery due to high risk factors.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Hypofractionated Radiation Therapy

Determine the maximum tolerated dose and tolerability of hypofractionated radiation therapy

3 months

Phase 2: Randomized Radiation Therapy

Participants are randomized to receive either conventionally fractionated or hypofractionated radiation therapy

3-6 weeks

Follow-up

Participants are monitored for safety, toxicity, and quality of life outcomes

24 months

Treatment Details

Interventions

• Intensity-modulated Radiation Therapy (IMRT) (Other)

Trial Overview The HYPORT trial tests a shorter course of post-op radiation therapy (IMRT) for head and neck cancer patients. Phase 1 checks safety and tolerability to find the right dose; Phase 2 compares swallowing quality of life and effectiveness against standard longer-term radiation treatments.

Participant Groups

Group I: Hypofractionated radiotherapy Experimental Treatment 1 Intervention

Dose and fractionation determined by Phase I: Level 1: 44.4 Gy in 12 fractions, 4 fractions/week Level 0: 46.5 Gy in 15 fractions, 5 fractions/week Level -1: 52 Gy in 20 fractions, 5 fractions/week Level -2: 50 Gy in 20 fractions, 5 fractions/week

Group II: Conventionally fractionated radiotherapy Active Control 1 Intervention

60 Gy in 30 fractions, 5 fractions/week

Intensity-modulated Radiation Therapy (IMRT) is already approved in Canada for the following indications:

Approved in Canada as Intensity-modulated Radiation Therapy for:

• Head and neck cancers
• Breast cancer
• Prostate cancer
• Rectal cancer

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Daniel K. Podolsky

University of Texas Southwestern Medical Center

Chief Executive Officer since 2008

MD from Harvard Medical School

Robert L. Bass

University of Texas Southwestern Medical Center

Chief Medical Officer since 2019

MD from University of Texas Southwestern Medical School

Findings from Research

Volumetric Modulated Arc Therapy (VMAT) significantly reduces radiation exposure to critical organs, such as the parotid glands and oral cavity, compared to Intensity-Modulated Radiation Therapy (IMRT), with average doses decreasing from 27.2 Gy to 25.0 Gy and from 39.4 Gy to 36.7 Gy, respectively.

VMAT also offers a substantial reduction in treatment delivery time, averaging 5:54 minutes compared to 13:15 minutes for IMRT, enhancing patient comfort and potentially minimizing movement during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-institutional comparison of volumetric modulated arc therapy vs. intensity-modulated radiation therapy for head-and-neck cancer: a planning study. Holt, A., Van Gestel, D., Arends, MP., et al.[2022]

A systematic review of 13 studies found that both volumetric-modulated arc therapy (VMAT) and intensity-modulated radiotherapy (IMRT) provide comparable dosimetric results for treating head and neck cancer, indicating that either technique can be effective.

VMAT may offer advantages such as better sparing of normal tissue, reduced treatment time, and fewer monitor units, although it also carries a risk of secondary cancer due to the higher number of monitor units compared to older techniques like 3D conformal radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric justification for the use of volumetric modulated arc therapy in head and neck cancer-A systematic review of the literature. Buciuman, N., Marcu, LG.[2022]

In a study of 385 head and neck cancer patients treated with advanced radiotherapy techniques (IMRT/VMAT) over a median follow-up of 6.4 years, locoregional control rates were high, with 2- and 5-year rates of 78.2% and 74.2%, respectively, indicating effective treatment delivery.

The study found very few recurrences outside the high-dose treatment areas, suggesting that target volume definition and treatment delivery were accurate, which is crucial for improving patient outcomes in future research on dose escalation or proton therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrence Patterns After IMRT/VMAT in Head and Neck Cancer. Bollen, H., van der Veen, J., Laenen, A., et al.[2022]

Volumetric Intensity-Modulated Arc Therapy (VMAT) shows promising benefits for head and neck cancer patients by providing treatment plans that have similar conformity and better homogeneity compared to traditional Intensity-Modulated Radiotherapy (IMRT).

VMAT also allows for quicker treatment times and requires fewer monitor units (MUs), although more clinical data is needed to fully assess its side effects and overall efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is VMAT beneficial for patients undergoing radiotherapy to the head and neck? Osborn, J.[2018]

In a study of 102 patients with stage III-IV head and neck cancer treated with Volumetric Modulated Arc Therapy (VMAT) and Simultaneous Integrated Boost (SIB), the treatment demonstrated a good toxicity profile, with specific dose correlations to mucosal toxicity and salivary gland effects.

The treatment resulted in promising overall survival rates of 83% at 3 years and 73% at 5 years, along with disease-free survival rates of 71% at 3 years and 34% at 5 years, indicating effective long-term outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity profile and early clinical outcome for advanced head and neck cancer patients treated with simultaneous integrated boost and volumetric modulated arc therapy. Franzese, C., Fogliata, A., Clerici, E., et al.[2022]

In a study of 56 patients with head and neck cancers treated with hypofractionated intensity modulated radiation therapy (H-IMRT), the two-year locoregional control rate was 87%, and the median overall survival was 46 months, indicating promising efficacy.

The treatment was well tolerated, with no severe grade 4 or 5 toxicities reported, and only 79% of patients experienced acute grade 2 or 3 toxicity, suggesting that H-IMRT is a safe option for patients with head and neck cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limited Toxicity of Hypofractionated Intensity Modulated Radiation Therapy for Head and Neck Cancer. Mayo, ZS., Ilori, EO., Matia, B., et al.[2022]

Intensity-modulated radiation therapy (IMRT) shows promise in treating head and neck cancer by delivering precise radiation doses, which may reduce side effects compared to traditional methods.

While advancements in IMRT techniques and target selection are being made, there is still a lack of mature clinical data to fully establish its safety and efficacy in head and neck cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy in the management of head and neck cancer. Hong, TS., Tomé, WA., Harari, PM.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Multi-institutional comparison of volumetric modulated arc therapy vs. intensity-modulated radiation therapy for head-and-neck cancer: a planning study. [2022]

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

Dosimetric justification for the use of volumetric modulated arc therapy in head and neck cancer-A systematic review of the literature. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Recurrence Patterns After IMRT/VMAT in Head and Neck Cancer. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Is VMAT beneficial for patients undergoing radiotherapy to the head and neck? [2018]

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

Toxicity profile and early clinical outcome for advanced head and neck cancer patients treated with simultaneous integrated boost and volumetric modulated arc therapy. [2022]

6. Greece pubmed.ncbi.nlm.nih.gov

Limited Toxicity of Hypofractionated Intensity Modulated Radiation Therapy for Head and Neck Cancer. [2022]

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

Intensity-modulated radiation therapy in the management of head and neck cancer. [2019]