Radiation Therapy for Nasopharyngeal Cancer

Overseen By Jamese Johnson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Platinum-based chemotherapy

Disqualifiers: Prior chemotherapy, Prior radiotherapy, others

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

Compensation: Varies

Number of Visits: 8

66 Participants Needed

Trial Summary

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. It's best to discuss your specific medications with the trial team to get a clear answer.

What data supports the effectiveness of the treatment Intensity-Modulated Radiation Therapy (IMRT) for nasopharyngeal cancer?

Research shows that Intensity-Modulated Radiation Therapy (IMRT) significantly improves the distribution of radiation doses and has led to positive clinical outcomes for patients with nasopharyngeal cancer, as seen in studies from institutions like the University of California-San Francisco and Memorial Sloan-Kettering. ^{1 2 3 4 5}

Is intensity-modulated radiation therapy (IMRT) safe for humans?

IMRT has been studied for nasopharyngeal cancer and is generally considered safe, but it can cause side effects. Studies show it may reduce some acute side effects compared to conventional radiation, but it can still lead to significant toxicities, especially when combined with chemotherapy, in both adults and children. ^{6 7 8 9 10}

How is intensity-modulated radiation therapy (IMRT) different from other treatments for nasopharyngeal cancer?

Intensity-modulated radiation therapy (IMRT) is unique because it uses advanced technology to precisely target cancer cells in the nasopharynx, minimizing damage to surrounding healthy tissue compared to traditional radiation methods. This precision allows for higher doses of radiation to be delivered directly to the tumor, potentially improving treatment outcomes. ^{1 3 11 12 13}

What is the purpose of this trial?

This clinical trial tests the effect of induction chemotherapy response-guided radiation (de-escalated intensity-modulated radiation therapy \[IMRT\]) compared to standard IMRT in patients with Epstein-Barr virus (EBV)-associated nasopharyngeal cancer. Intensity-modulated radiation therapy (IMRT) is an advanced form of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Radiation therapy sometimes causes unwanted symptoms or side effects, including late effects such as hearing loss and dental problems. The severity of the side effects is related to the radiation dose received and the amount of tissue that received radiation. De-escalation IMRT uses lower doses of radiation based on a good response to induction chemotherapy. Giving de-escalated IMRT may be as effective as standard doses of IMRT in treating patients with EBV-associated nasopharyngeal cancer.

Research Team

Sue S. Yom

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for individuals with nasopharyngeal cancer linked to the Epstein-Barr virus. Participants should respond well to initial chemotherapy, as their subsequent radiation therapy dose will be adjusted based on this response.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

I have completed treatment with platinum-based chemotherapy.

I have another cancer that won't affect this treatment's safety or results.

Exclusion Criteria

I do not have any severe, active illnesses like heart problems, serious lung issues, or untreated infections.

Individuals with conditions impairing ability to comply with study activities or interfere with participant safety

I have had chemotherapy for nasopharyngeal cancer, but not as initial treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Participants receive induction chemotherapy to assess response before radiation therapy

6-8 weeks

Radiation

Participants undergo either de-escalated or standard IMRT 5 days a week for up to 7 weeks

7 weeks

5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 10 years

Initial follow-up at 3 months, then every 6 months

Treatment Details

Interventions

• Intensity-Modulated Radiation Therapy (IMRT)

Trial Overview The study compares two radiation therapies in EBV-associated nasopharyngeal cancer patients: standard Intensity-Modulated Radiation Therapy (IMRT) and a lower-dose IMRT guided by how well patients respond to initial chemotherapy.

Participant Groups

Group I: Arm II (standard IMRT) Experimental Treatment 3 Interventions

Patients undergo standard IMRT QD 5 days a week for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Participants also undergo CT, MRI, PET, PET/CT, CT, and/or bone scans as well as providing blood samples throughout the trial.

Group II: Arm I (de-escalated Intensity Modulated Radiation Therapy (IMRT) Experimental Treatment 3 Interventions

Participants undergo de-escalated IMRT every day (QD) 5 days a week for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Participants also undergo CT, MRI, PET, PET/CT, CT, and/or bone scans as well as providing blood samples throughout the trial.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Findings from Research

In a study of five pediatric patients with nasopharyngeal carcinoma treated with intensity-modulated radiotherapy (IMRT) and chemotherapy, all patients experienced severe acute toxicities (grade 3-4).

Despite the use of IMRT, which is designed to reduce treatment-related complications, all patients developed significant long-term toxicities, including hypothyroidism, xerostomia, hearing loss, and dental disease, indicating that IMRT plus chemotherapy may not significantly lower long-term risks in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single institution experience with pediatric nasopharyngeal carcinoma: high incidence of toxicity associated with platinum-based chemotherapy plus IMRT. Louis, CU., Paulino, AC., Gottschalk, S., et al.[2016]

References

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

Intensity-modulated radiotherapy in the treatment of nasopharyngeal carcinoma: an update of the UCSF experience. [2022]

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

Clinical outcomes and patterns of failure after intensity-modulated radiotherapy for nasopharyngeal carcinoma. [2022]

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

Three-dimensional intensity-modulated radiotherapy in the treatment of nasopharyngeal carcinoma: the University of California-San Francisco experience. [2019]

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

Intensity-modulated radiation therapy (IMRT) for nasopharynx cancer: update of the Memorial Sloan-Kettering experience. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Retrospective analysis of effectiveness of intensity-modulated radiotherapy combined with chemotherapy or not for locoregionally advanced nasopharyngeal carcinoma]. [2019]

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

Treatment of nasopharyngeal carcinoma using intensity-modulated radiotherapy-the national cancer centre singapore experience. [2022]

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

Nasopharyngeal carcinoma in children: comparison of conventional and intensity-modulated radiotherapy. [2022]

8. China pubmed.ncbi.nlm.nih.gov

[Comparison of side effects of intensity modulated radiotherapy and conventional radiotherapy in 69 cases with nasopharyngeal carcinoma]. [2019]

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

Locoregionally advanced nasopharyngeal carcinoma in childhood and adolescence: Analysis of 95 patients treated with combined chemotherapy and intensity-modulated radiotherapy. [2022]

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

A single institution experience with pediatric nasopharyngeal carcinoma: high incidence of toxicity associated with platinum-based chemotherapy plus IMRT. [2016]

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

Treatment planning and delivery of intensity-modulated radiation therapy for primary nasopharynx cancer. [2019]

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

Effect of intensity-modulated radiotherapy versus two-dimensional conventional radiotherapy alone in nasopharyngeal carcinoma. [2022]

13. China pubmed.ncbi.nlm.nih.gov

[Intensity modulated radiation therapy for 49 patients with recurrent nasopharyngeal carcinoma]. [2006]