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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a lower dose of radiation therapy, known as de-escalated intensity-modulated radiation therapy (IMRT), is as effective as the standard dose for treating nasopharyngeal cancer linked to the Epstein-Barr virus (EBV). The aim is to determine if less radiation can reduce side effects like hearing loss and dental issues while still effectively treating the cancer. Participants with EBV-associated nasopharyngeal cancer who plan to start platinum-based chemotherapy may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both reduced-dose and standard Intensity-Modulated Radiation Therapy (IMRT) are generally well-tolerated for treating nasopharyngeal cancer. In reduced-dose IMRT, one study found high survival rates, with 93.5% of patients experiencing no cancer recurrence in the treated area over five years. This suggests effective cancer control with a lower radiation dose, potentially leading to fewer side effects due to less impact on healthy tissue.

Standard IMRT also demonstrates good safety results. Studies report satisfactory long-term survival rates, with a 5-year overall survival rate of about 91.9%. Most patients tolerate this type of radiation well, though some may experience common side effects like hearing loss or dental issues.

Both treatments aim to minimize harm to healthy tissue while effectively targeting cancer. Overall, research suggests these treatments are safe, but individual experiences with side effects can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these radiation therapy techniques for nasopharyngeal cancer because they offer potential improvements over standard treatments. Intensity-Modulated Radiation Therapy (IMRT) is known for its precision, but this trial explores two variations: a de-escalated version and the standard IMRT. The de-escalated IMRT aims to reduce the radiation dose while maintaining effectiveness, potentially minimizing side effects and improving patient quality of life. Both approaches are tailored to target the tumor more accurately, which could lead to better outcomes and fewer complications compared to traditional radiation therapy methods.

What evidence suggests that this trial's treatments could be effective for nasopharyngeal cancer?

Research has shown that Intensity-Modulated Radiation Therapy (IMRT) effectively treats nasopharyngeal cancer. Studies indicate that patients receiving IMRT have a 5-year survival rate of 77-85%. In this trial, participants will join one of two treatment arms. Arm I involves de-escalated IMRT, which uses lower radiation doses after a good response to chemotherapy and might be as effective as standard IMRT. This approach has been linked to prolonged periods without disease progression and fewer side effects. Arm II involves standard IMRT, which also demonstrates strong results, with survival rates between 84-90% in early-stage cases. Both treatments aim to control the disease while minimizing harm to healthy tissue. ^{1 3 6 7 8}

Who Is on the Research Team?

Sue S. Yom

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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

Individuals of child-bearing potential must have documentation of a negative pregnancy test

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6775602/

Safety and Effectiveness of De-escalated Radiation Dose ...

IMRT is widely used in NPCs and several studies have reported 5-year LRFS at 86-92% and 5-year OS at 77-85% in large cohorts-. Therefore, IMRT is recommended as ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1368837522004286

Long-term results of the phase II dose and volume de- ...

Intensity-modulated radiotherapy (IMRT) has improved treatment outcomes and become the standard radiotherapy technique in the past decade for nasopharyngeal ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36179488/

Long-term results of the phase II dose and volume de- ...

Conclusion: Dose and volume de-escalated IMRT was associated with high PFS and mild late neurological toxicities for IC responders. Further ...

4.

europepmc.org

europepmc.org/article/med/36179488

Long-term results of the phase II dose and volume de- ...

Conclusion. Dose and volume de-escalated IMRT was associated with high PFS and mild late neurological toxicities for IC responders. Further ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06682442

Induction Chemotherapy Response-Guided Radiation for ...

Giving de-escalated IMRT may be as effective as standard doses of IMRT in treating patients with EBV-associated nasopharyngeal cancer. PRIMARY OBJECTIVE: I.

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0360301610032505

Long-Term Outcomes of Early-Stage Nasopharyngeal ...

The present study evaluated the long-term survival outcomes and toxicity of early-stage NPC patients treated with IMRT alone.

7.

researchgate.net

researchgate.net/publication/335729135_Safety_and_Effectiveness_of_De-escalated_Radiation_Dose_in_T1-3_Nasopharyngeal_Carcinoma_A_Propensity_Matched_Analysis

Safety and Effectiveness of De-escalated Radiation Dose ...

Results: With a median follow-up time of 50 months, the 5-year loco-regional failure-free survival (LRFS) and overall survival (OS) were 93.5% ...

8.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2795527

Radiotherapy With vs Without Chemoradiotherapy and ...

Among patients with low-risk nasopharyngeal carcinoma, IMRT alone compared with concurrent chemoradiotherapy was not inferior for 3-year failure-free survival.