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

Trial Summary

What is the purpose of this trial?

The researchers are doing this study is to find out if lower doses (given in fewer treatments over a shorter period of time) of radiation therapy in combination with standard-of-care chemotherapy is an effective treatment for people with Human Papilloma Virus (HPV)-positive throat cancer and works as well as the standard doses of radiation therapy in combination with standard-of-care chemotherapy. The chemotherapy drugs used in combination with radiation therapy in this study include cisplatin, carboplatin, and 5-fluorouracil (5-FU).

Research Team

Nancy Lee, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+