Reduced Radiation Doses for Throat Cancer

Recruiting at 1 trial location

Overseen By Michael Sim, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Anesthesia issues, Metastatic disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 4

83 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment involving reduced radiation doses for throat cancer?

Research suggests that reducing radiation doses can help minimize side effects like dysphagia (difficulty swallowing) and xerostomia (dry mouth) while still maintaining tumor control, as seen in studies of proton therapy for oropharyngeal cancer. Additionally, hyperfractionated radiation therapy has shown improved local control rates for advanced carcinomas of the upper aerodigestive tracts, indicating potential benefits of adjusted radiation dosing. ^{1 2 3 4 5}

Is reduced radiation therapy for throat cancer safe for humans?

Research suggests that using proton therapy, a type of reduced radiation treatment, can lower the risk of side effects like dry mouth and difficulty swallowing, while still effectively treating cancer. This approach may improve overall well-being by reducing fatigue and nausea, indicating it is generally safe for humans. ^{3 5 6 7 8}

How does the reduced radiation dose treatment for throat cancer differ from other treatments?

This treatment uses lower doses of radiation (44 or 54 doses) compared to the standard higher doses typically used for throat cancer, which can help reduce side effects like dysphagia (difficulty swallowing) and laryngeal edema (swelling of the voice box). By minimizing radiation exposure, it aims to maintain tumor control while improving the patient's quality of life. ^{1 2 9 10 11}

What is the purpose of this trial?

Oropharyngeal squamous cell carcinoma (OPSCC), commonly known as throat cancer or tonsil cancer, has seen a dramatic rise in incidence over the last twenty years. There are two types of OPSCC: human papillomavirus-positive (HPV+) and human papillomavirus-negative (HPV-). People with OPSCC, regardless of their type, typically receive standard treatment with a combination of chemotherapy, radiation therapy, and surgery. Due to the intensity of standard treatment, survivors may experience unwanted long-term side effects. The goal of this research study is to see if intensifying (stopping or scaling back) treatment still provides the same, or perhaps even better, results when compared to standard treatment.

Research Team

Michael Sim, MD

Principal Investigator

Indiana University School of Medicine, Indiana University Simon Cancer Center

Eligibility Criteria

This trial is for adults over 18 with HPV-positive throat cancer that can be removed surgically. They should have a performance status indicating they are relatively active and must not have distant spread of cancer or other cancers in the last 5 years, except certain skin and thyroid cancers. Women must not be pregnant or breastfeeding.

Inclusion Criteria

My cancer is confirmed as squamous cell carcinoma.

I have more than one primary cancer at the same time.

My cancer is in an early stage (T1 or T2).

Exclusion Criteria

I have a health condition that makes general anesthesia unsafe for me.

I have not had head or neck radiation or cancer in the last 3 years.

I am of childbearing age and have a recent negative pregnancy test.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo transoral robotic surgery (TORS) for HPV+ OPSCC

1 week

1 visit (in-person)

Adjuvant Treatment

Participants receive adjuvant radiation therapy based on risk stratification

6 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular follow-up visits including a surveillance visit 3 months after surgery

Treatment Details

Interventions

• 44 doses of radiation
• 54 doses of radiation

Trial Overview The study is testing if reducing the intensity of treatment after surgery for HPV-positive throat cancer by giving fewer radiation doses (44 instead of the standard 54) affects recovery outcomes. It aims to see if less intense treatment leads to similar or better results than current standards.

Participant Groups

Group I: Adjuvant Radiation 54 Gray Experimental Treatment 1 Intervention

If patients have 4 or fewer positive nodes with greater than 2 mm of cancer spread extending outside the lymph nodes or 5 or more positive nodes with 2 mm or less of cancer spread extending outside the lymph nodes, patients will receive 54 gray fractions (the full dose of radiation divided into smaller doses) of adjuvant radiation.

Group II: Adjuvant Radiation 44 Gray Experimental Treatment 1 Intervention

If patients have 4 or fewer positive nodes and 2 mm or less of cancer spread extending outside the lymph nodes, patients will receive 44 gray fractions (the full dose of radiation divided into smaller doses) of adjuvant radiation.

Group III: Observation Active Control 1 Intervention

If patients have negative margins and have all negative nodes or only a single positive node, patients will be placed in the observation arm and will not receive further adjuvant treatment, only postoperative follow-up visits and a surveillance visit 3 months after surgery with a CT or PET-CT.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

References

1. France pubmed.ncbi.nlm.nih.gov

[Normal tissue tolerance to external beam radiation therapy: larynx and pharynx]. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Radiation of jejunal interposition in T3-T4 upper aerodigestive tumours. [2019]

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

Radiation dose and second cancer risk in patients treated for cancer of the cervix. [2022]

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

Dose-response for local control with hyperfractionated radiation therapy in advanced carcinomas of the upper aerodigestive tracts: preliminary report of radiation therapy oncology group protocol 83-13. [2019]

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

Reduced radiation-induced toxicity by using proton therapy for the treatment of oropharyngeal cancer. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Medical effects and risks of exposure to ionising radiation. [2012]

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

Carcinogenesis--a synopsis of human experience with external exposure in medicine. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

[No convincing evidence for a causal relationship between childhood nasopharyngeal radium irradiation and head-neck tumors or hormone-related disorders later in life; a retrospective cohort study]. [2006]

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

The steepness of the dose response curve both for tumor cure and normal tissue injury. [2006]

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

Uniform FDG-PET guided GRAdient Dose prEscription to reduce late Radiation Toxicity (UPGRADE-RT): study protocol for a randomized clinical trial with dose reduction to the elective neck in head and neck squamous cell carcinoma. [2019]

11. Sweden pubmed.ncbi.nlm.nih.gov

Low dose irradiation in advanced tumours of head and neck. [2019]