43 Participants Needed

Low-Dose Chemoradiotherapy for Oropharyngeal Cancer

MP
IS
JB
Overseen ByJohn Botzler
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot be on any other anticancer therapy while participating in this trial.

What data supports the effectiveness of the treatment PTV50.4, PTV56 for oropharyngeal cancer?

Research shows that reducing the dose of chemoradiation (a combination of chemotherapy and radiation therapy) for HPV-positive oropharyngeal cancer can lead to good functional outcomes and quality of life, while still being effective. This suggests that lower doses, like those in PTV50.4 and PTV56, might be beneficial for patients.12345

Is low-dose chemoradiotherapy for oropharyngeal cancer safe?

Studies on low-dose chemoradiotherapy for HPV-positive oropharyngeal cancer show it can be safe, with some patients experiencing side effects like severe mouth sores and difficulty swallowing. However, these side effects are generally less severe compared to standard treatments, and long-term follow-up is needed to confirm safety.26789

How does the treatment PTV50.4, PTV56 for oropharyngeal cancer differ from other treatments?

This treatment involves a lower dose of chemoradiotherapy, which means using less radiation and chemotherapy than standard treatments. This approach aims to reduce long-term side effects while maintaining effectiveness, especially for patients with human papillomavirus-positive oropharyngeal cancer.123410

What is the purpose of this trial?

The purpose of this study is to establish the efficacy and toxicity of low dose chemoradiotherapy after induction chemotherapy in patients with locally advanced HPV+ oropharynx cancer and establish prognostic factors that would apply to help select patients for this treatment in the future.

Research Team

In the Office with Dr. Marshall Posner ...

Marshall R. Posner

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

Adults over 18 with HPV+ oropharyngeal cancer that's not been treated before can join. They need a biopsy for testing, no heavy alcohol use in the last 6 months, and good organ function. Pregnant women, those unwilling to use contraception, people with other cancers (except certain types), severe neuropathy or hearing loss, lung disease, recent heart attack or serious illness can't participate.

Inclusion Criteria

My cancer is HPV positive and located in the throat, nasal area, or related regions.
No active alcohol addiction (as assessed by medical caregiver and defined as at least 6 months without activity)
My liver, kidneys, and bone marrow are functioning well.
See 11 more

Exclusion Criteria

I have lost more than 25% of my weight without trying in the last 2 months.
Participation in an investigational therapeutic drug trial within 30 days of study entry
Active smoking or a cumulative pack year history of > 20 pack years, active smoking is (Defined as ≥ 1 cigarette per day) within the last 5 years
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Participants receive induction chemotherapy to establish efficacy and toxicity before chemoradiotherapy

6-8 weeks

Reduced Dose Chemoradiotherapy

Participants receive daily radiation treatment with intensity-modulated radiotherapy (IMRT) for 5 days per week

6-7 weeks

Follow-up

Participants are monitored for safety, effectiveness, and long-term toxicity after treatment

5 years

Treatment Details

Interventions

  • PTV50.4
  • PTV56
Trial Overview The trial is testing if lower doses of chemoradiotherapy after initial chemotherapy are effective and safe for advanced HPV-related throat cancer patients. It also aims to identify factors predicting who benefits from this approach.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Reduced Dose RadiationExperimental Treatment2 Interventions
All patients will receive daily radiation treatment with intensity-modulated radiotherapy (IMRT) - PTV56 and PTV50.4. Treatment will be given 5 days per week and will not routinely be delivered on Saturday, Sunday or major holidays unless a treatment is missed during the week due to technical and/or medical reasons. No more than 5 treatments should be given per week.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

Findings from Research

In a phase 2 trial involving 45 patients with HPV-positive oropharyngeal cancer, de-escalated chemoradiation therapy resulted in a low rate of gastrostomy tube placement (5%) and allowed 95% of patients to return to a normal diet after treatment, indicating improved functional outcomes.
Patients who had a normal BMI before treatment were able to recover to baseline BMI levels approximately 18 months post-therapy, suggesting that the treatment approach may help maintain nutritional status and quality of life.
Functional Outcomes After De-escalated Chemoradiation Therapy for Human Papillomavirus-Positive Oropharyngeal Cancer: Secondary Analysis of a Phase 2 Trial.Hegde, JV., Shaverdian, N., Felix, C., et al.[2019]
A de-escalation strategy of reduced adjuvant radiation and chemotherapy after surgery for HPV-positive oropharyngeal cancer resulted in low long-term toxic effects, with only 1.4% experiencing grade 2 toxic effects at 1 year and no grade 4-5 toxic effects reported.
Patients showed significant improvements in swallow function and quality of life over time, with most returning to baseline levels, indicating that this treatment approach is both effective and preserves patient well-being.
Long-Term Toxic Effects, Swallow Function, and Quality of Life on MC1273: A Phase 2 Study of Dose De-escalation for Adjuvant Chemoradiation in Human Papillomavirus-Positive Oropharyngeal Cancer.Price, K., Van Abel, KM., Moore, EJ., et al.[2022]
Patients with HPV-positive oropharyngeal cancer who underwent risk- and response-adapted de-escalated radiation therapy (RT) and chemoradiation (CRT) showed significantly better functional outcomes, including improved swallowing function and higher body mass index (BMI), compared to those receiving standard high-dose treatment.
The study found that lower treatment intensity (RT50/CRT45) was associated with less PEG-tube dependency and reduced narcotic use, highlighting the benefits of de-escalation in treatment for this patient population.
Dose and Volume De-Escalation for Human Papillomavirus-Positive Oropharyngeal Cancer is Associated with Favorable Posttreatment Functional Outcomes.Foster, CC., Seiwert, TY., MacCracken, E., et al.[2021]

References

Functional Outcomes After De-escalated Chemoradiation Therapy for Human Papillomavirus-Positive Oropharyngeal Cancer: Secondary Analysis of a Phase 2 Trial. [2019]
Long-Term Toxic Effects, Swallow Function, and Quality of Life on MC1273: A Phase 2 Study of Dose De-escalation for Adjuvant Chemoradiation in Human Papillomavirus-Positive Oropharyngeal Cancer. [2022]
Radiotherapy dose and survival outcomes in human papillomavirus positive oropharyngeal cancer. [2020]
Dose and Volume De-Escalation for Human Papillomavirus-Positive Oropharyngeal Cancer is Associated with Favorable Posttreatment Functional Outcomes. [2021]
Comparisons of dysphagia and quality of life (QOL) in comparable patients with HPV-positive oropharyngeal cancer receiving chemo-irradiation or cetuximab-irradiation. [2018]
Weight Loss and Percutaneous Endoscopic Gastrostomy Tube Placement during Chemoradiotherapy for Locally Advanced Cancer of the Oropharynx Do Not Negatively Impact Outcomes. [2022]
De-intensification of therapy in human papillomavirus associated oropharyngeal cancer: A systematic review of prospective trials. [2021]
Reduced-dose radiotherapy for human papillomavirus-associated squamous-cell carcinoma of the oropharynx: a single-arm, phase 2 study. [2022]
Regional control is preserved after dose de-escalated radiotherapy to involved lymph nodes in HPV positive oropharyngeal cancer. [2016]
Triweekly carboplatin as a potential de-intensification agent in concurrent chemoradiation for early-stage HPV-associated oropharyngeal cancer. [2020]
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