Reduced Radiation + Chemotherapy for Throat Cancer

Recruiting at 6 trial locations

Overseen By Nancy Lee, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Prior head/neck radiation, 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: Unknown

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether lower doses of radiation therapy, combined with standard chemotherapy, can treat HPV-positive throat cancer as effectively as the usual higher doses of radiation. The goal is to determine if reduced radiation, along with chemotherapy drugs like cisplatin, carboplatin, and 5-fluorouracil (5-FU), is effective. Individuals with HPV-positive throat cancer and noticeable tumors might be suitable candidates for this trial. The study offers a chance to potentially experience fewer side effects from radiation while still receiving effective cancer treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial information does not specify if 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 this trial's treatments are likely to be safe?

Research shows that the treatments in this study are generally safe. Studies have found 5-fluorouracil (5-FU) effective even at low doses. It is widely used and usually well-tolerated. Carboplatin treats throat cancers and is considered safe, though it can cause side effects like nausea and low blood counts. Cisplatin, another common drug for these cancers, is especially important for treating HPV-positive cases, but it can lead to hearing loss or kidney problems.

Reduced radiation therapy has been studied for HPV-positive throat cancers. Research suggests it might improve quality of life by reducing long-term side effects while remaining safe. Overall, these treatments have a strong safety record, but side effects can vary. Discuss potential risks with a doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this treatment protocol because it offers a potentially less intense approach for people with HPV-positive throat cancer. Unlike the standard treatment, which often involves high doses of radiation (around 70Gy) with chemotherapy, this protocol uses significantly reduced radiation (30Gy) for qualifying patients. This is possible through the use of advanced imaging techniques to assess tumor hypoxia, allowing for more personalized treatment. This approach aims to maintain effectiveness while potentially reducing side effects and recovery time, making it a promising option for improving patients' quality of life.

What evidence suggests that reduced radiation therapy with chemotherapy is effective for HPV-positive throat cancer?

This trial will evaluate the effectiveness of reduced radiation therapy combined with chemotherapy for treating HPV-positive throat cancer. Research has shown that lowering the radiation dose while using chemotherapy can be effective for this condition. Studies have found that using less radiation can greatly reduce treatment side effects without losing effectiveness. For instance, one study found that a lower radiation dose of 30 Gy, combined with chemotherapy, still achieved good results in patients with advanced cancer. Another study demonstrated that this method can reduce harmful effects and improve patients' quality of life. In this trial, participants will receive chemotherapy drugs like cisplatin, carboplatin, and 5-fluorouracil alongside reduced radiation therapy. This approach aims to treat the cancer successfully while making the treatment less harsh. ^{4 6 7 8 9}

Who Is on the Research Team?

Nancy Lee, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with HPV-positive throat cancer, including thyroid and oropharynx cancers. Participants must be suitable for chemotherapy combined with radiation therapy. Specific eligibility criteria are not provided, but typically include factors like age, health status, and cancer stage.

Inclusion Criteria

My throat cancer has not spread to distant parts of my body.

Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential

Subject must provide study-specific informed consent prior to study entry

Exclusion Criteria

I've been cancer-free for 3 years or had a cancer with a high cure rate.

Severe, active co-morbidity as defined

Subjects with simultaneous primary cancers outside of the oropharynx if determined by the PI/Co-PI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Participants undergo 6 weeks of standard induction chemotherapy

6 weeks

Radiation Therapy with Chemotherapy

Participants receive de-escalated radiation therapy to 30Gy concurrent with standard chemotherapy if downstaged and no hypoxia is detected, otherwise standard 70Gy with chemotherapy

8-10 treatment days

Follow-up

Participants are monitored for locoregional control and safety after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• 5-fluorouracil (5-FU)
• Carboplatin
• Cisplatin
• Reduced Radiation Therapy

Trial Overview The study tests if lower doses of radiation over a shorter period, alongside standard chemotherapy drugs (cisplatin, carboplatin, 5-FU), can effectively treat HPV-positive throat cancer compared to the standard radiation regimen.

How Is the Trial Designed?

Group I: Radiation Therapy With Chemotherapy in People With HPV-Positive Throat Cancer Experimental Treatment 3 Interventions

Subjects will first undergo 6 weeks of standard induction chemotherapy and if downstaged to T1-2 and \<N3 and also have no evidence of hypoxia will undergo a major de-escalated radiation therapy to 30Gy concurrent with standard chemotherapy. Hypoxia status is determined by the absence of hypoxia uptake on Fluorine-18-Labeled Fluoro-Misonidazole (18F-FMISO) PET/CT imaging (8-10 treatment days after start of chemoradiation), which has an FDA approved IND for use in humans . If the 18F-FMISO PET is negative for hypoxia, the patient will receive 30Gy concurrent with 2 cycles of chemotherapy. If the 18F-FMISO PET is positive for hypoxia, the patient will receive standard of care 70Gy concurrent with 3 cycles of chemotherapy.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. practicalradonc.org practicalradonc.org/article/S1879-8500(24)00139-5/fulltext

Radiation Therapy for HPV-Positive Oropharyngeal ... Clinical outcomes of head and neck cancer patients who undergo resection, but forgo adjuvant therapy ... reduced acute and late radiation ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8778604/

Evaluation of Substantial Reduction in Elective ... In this cohort study, reduced radiotherapy volume and dose of 30 Gy to the elective regions with concurrent chemotherapy in 276 patients with locally advanced ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1368837524001684

Translational risk-adapted approaches to de-escalated ... These studies have shown that de-escalated radiation for HPV-positive oropharyngeal carcinoma can significantly decrease toxicity while maintaining the ...

4. mskcc.org mskcc.org/clinical-updates/reducing-radiation-select-patients-hpv-associated-mouth-and-throat

Reducing Radiation for Select Patients with HPV- ... Based on historical data and recent trials specific to HPV-positive oropharyngeal carcinoma, we have reduced the radiation dose to elective ...

5. newsnetwork.mayoclinic.org newsnetwork.mayoclinic.org/discussion/shorter-less-intense-radiation-chemo-regimen-effective-for-hpv-linked-oropharyngeal-cancer-mayo-study-shows/

Shorter, less intense radiation-chemo regimen effective for ... Shorter, less intense radiation-chemo regimen effective for HPV-linked oropharyngeal cancer, Mayo study shows. Learn more.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7720313/

Targeting laryngeal cancer cells with 5-fluorouracil and ... The results demonstrated that 5-FU was more effective at low concentrations, whereas CRC was more effective at high concentrations. In addition, ...

7. annalsofoncology.org annalsofoncology.org/article/S0923-7534(20)33592-4/fulltext

Safety and Efficacy of Cisplatin Plus 5-Fu and Cetuximab in ... Among HPV- pts, CT + cetuximab (n = 178) improved overall survival (OS), progression-free survival (PFS) and overall response rate (ORR), compared with CT (n = ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0923753419367067

Prognostic significance of human papillomavirus in ... The median survival was 12.9 versus 6.7 months for HPV-positive versus HPV-negative patients (P = 0.014), and 11.9 versus 6.7 months for p16-positive versus p16 ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9619415/

Induction Chemotherapy in Low-Risk HPV+ Oropharyngeal ... Overall survival in the low-risk group was observed to be 93%, compared to 70.8% in the intermediate group [44]. O'Sullivan et al. later assessed 505 patients ...