Reduced Intensity Radiation for Head and Neck Cancer

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Disqualifiers: Previous head/neck cancer, surgery, pregnancy, 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: 33

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether reducing radiation to non-cancerous areas of the neck can lessen side effects for people with head and neck cancer. It employs intensity modulated radiation therapy (IMRT) to precisely target cancerous areas while sparing healthy tissue. Suitable candidates for this trial include those who have undergone surgery for tumors in the mouth, throat, or voice box and require radiation treatment due to specific concerns, such as close or positive tumor margins or cancer spread to multiple lymph nodes. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to benefit from potentially effective therapy.

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.

Is there any evidence suggesting that intensity modulated radiation therapy is likely to be safe for humans?

Research has shown that intensity modulated radiation therapy (IMRT) for head and neck cancer is generally manageable for patients. Studies have found that IMRT results in fewer long-term side effects compared to older radiation methods. IMRT can more precisely target tumors while protecting healthy tissue, reducing unwanted effects.

Another study found that both IMRT and proton therapy led to fewer long-term side effects than expected. Patients reported good tumor control and fewer problems over time.

Overall, evidence suggests that IMRT is a safe option that reduces side effects for patients with head and neck cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about this trial because it explores a potentially gentler approach to treating head and neck cancer using intensity modulated radiation therapy (IMRT). Unlike traditional radiation therapies that might use a one-size-fits-all approach, IMRT allows for precise targeting of the tumor based on its specific site and stage. This method could mean fewer side effects, as it aims to reduce radiation exposure to surrounding healthy tissues. By tailoring the radiation dose more accurately, the hope is to maintain effectiveness while minimizing damage, potentially improving patients' quality of life during treatment.

What evidence suggests that reduced intensity radiation therapy might be an effective treatment for head and neck cancer?

Research has shown that intensity-modulated radiation therapy (IMRT), which participants in this trial will receive, works well for head and neck cancer. One study found that after about 28 months, 96.8% of patients who received IMRT did not experience cancer recurrence at or near the original site. This high success rate indicates that IMRT effectively controls the disease. IMRT accurately targets the tumor, helping to protect healthy tissue from unnecessary radiation. This precision can reduce side effects while still effectively treating the cancer. Therefore, strong evidence supports IMRT as a successful treatment option for head and neck cancer. ^{2 5 6 7 8}

Who Is on the Research Team?

Wade Thorstad, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain types of head and neck cancer, specifically in the oral cavity, oropharynx, larynx, or hypopharynx. They should have had surgery already and show no signs of cancer on one or both sides of their neck. The trial isn't open to those who've had previous head and neck cancers (except non-melanoma skin cancer), prior head and neck surgeries, or women who are pregnant or nursing.

Inclusion Criteria

My cancer in the mouth or throat was surgically removed and did not spread to my neck.

I need radiation therapy due to certain high-risk features of my cancer.

Patients must sign study specific, Institutional Review Board (IRB)-approved consent form

Exclusion Criteria

I have had surgery on my head or neck before.

I have had head and neck cancer before, but not skin cancer.

I am not pregnant or nursing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive intensity modulated radiation therapy (IMRT) with guidelines for volume contoured based on tumor site and stage

6-7 weeks

33 visits (in-person) for radiation fractions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including imaging studies to assess recurrence

Minimum of 5 years

Quality of Life Assessment

Quality of Life (QOL) is evaluated using the Swallowing and Dryness Questionnaire

22 months

What Are the Treatments Tested in This Trial?

Interventions

• Intensity modulated radiation therapy

Trial Overview The study is testing whether reducing radiation therapy to areas without evident cancer can lessen side effects for patients with head and neck cancer. It involves adjusting the amount of radiation away from healthy tissue after surgical removal of tumors.

How Is the Trial Designed?

Group I: Intensity modulated radiation therapy (IMRT) Experimental Treatment 1 Intervention

-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17522243/

Intensity-modulated radiation therapy for head and neck ... Intensity-modulated radiation therapy (IMRT) for head and neck tumors refers to a new approach that aims at increasing the radiation dose gradient.

2. astro.org astro.org/news-and-publications/news-and-media-center/news-releases/2025/imrt-matches-proton-therapy-in-patient-reported-outcomes-for

Intensity-modulated radiation therapy (IMRT) matches ... At a median follow-up of 28.3 months, two-year freedom from cancer returning at or near the original tumor site was 94.3% for protons and 96.8% ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814023898656

Comparing the oncologic outcomes of proton therapy and ... This study of 60,485 patients with HNSCC found that proton therapy was associated with better overall and cancer-specific survival and lower locoregional ...

4. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-023-02327-z

The cost effectiveness of intensity-modulated radiation therapy ... This study concluded that in the treatment of head and neck cancer, the 3-dimensional conformal radiation therapy method appears to be cost-effective.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2798320

Toxicity Profiles and Survival Outcomes Among Patients ... Most patients (283 [97%]) received a dose to the primary tumor of 70 Gy. Fifty-seven of the patients treated with IMPT (98%) and 215 of those ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22342095/

Patterns of care and outcomes associated with intensity ... IMRT was not associated with differences in survival: the 3-year overall survival was 50.5% for IMRT vs. 49.6% for standard RT (p = 0.47). The 3 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39007360/

Efficacy and safety of proton therapy versus intensity ... Proton therapy demonstrated superior overall survival (OS), disease-free survival (DFS), and better local control rate (LCR) compared to IMRT.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1368837518303324

Patterns of failure, treatment outcomes and late toxicities ... IMRT for head and neck cancer has significantly reduced late toxicities compared to older RT techniques. Prospective studies will focus on improving treatment ...