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Alkylating agents

Reduced-Intensity Chemoradiotherapy for Oropharyngeal Cancer

Phase 2

Waitlist Available

Led By Bhishamjit Chera, MD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

T0-3, N0 to N2c, M0 squamous cell carcinoma of the oropharynx

Biopsy proven squamous cell carcinoma that is HPV and/or p16 positive

Must not have

Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; Transmural myocardial infarction within the last 6 months; Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (Note, however, coagulation parameters are not required for entry into this protocol); Pre-existing ≥ grade 2 neuropathy; Prior organ transplant; Systemic lupus; Psoriatic arthritis

Prior history of radiation therapy to the head and neck

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years after completion of crt on last enrolled patient (note: crt duration is 6 weeks).

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a lower-intensity radiation and chemotherapy regimen to treat HPV-associated head and neck cancers. The goal is to see if it is as effective as the current standard of care while causing fewer side effects.

Who is the study for?

Adults with low-risk HPV-related oropharyngeal squamous cell carcinoma, who are generally healthy and have a light smoking history. They must have good organ function, limited alcohol consumption, and be able to follow the study plan. Pregnant women and those with severe health issues like heart disease or uncontrolled infections cannot participate.

What is being tested?

The trial is testing if lower-intensity radiation for one less week combined with reduced chemotherapy doses can effectively treat HPV-related head and neck cancers compared to the standard longer treatment. It aims to see if this approach maintains high cure rates while reducing side effects.

What are the potential side effects?

Potential side effects include reactions related to lower doses of chemotherapy such as nausea, fatigue, kidney issues, blood count changes; and from radiation therapy like skin irritation in the treated area, dry mouth or difficulty swallowing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is in the oropharynx and hasn't spread far.

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My cancer is squamous cell and tests positive for HPV or p16.

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I am fully active or can carry out light work.

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My recent blood tests show enough platelets and hemoglobin.

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My kidney and liver tests are within normal limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy to my head or neck before.

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I have had head or neck cancer in the past.

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My cancer cannot be removed with surgery.

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I am currently on medication for rheumatoid arthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years after completion of crt on last enrolled patient (note: crt duration is 6 weeks).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two years after completion of crt on last enrolled patient (note: crt duration is 6 weeks).

This trial's timeline: 3 weeks for screening, Varies for treatment, and two years after completion of crt on last enrolled patient (note: crt duration is 6 weeks). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

2 Year Progression Free Survival After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)

Secondary study objectives

Human papillomavirus

2 Year Local Control (LC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)

2 Year Local-regional Control (LRC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: De-escalated Radiation and ChemotherapyExperimental Treatment3 Interventions

Patients will receive Intensity Modulated Radiotherapy Treatments (IMRT), 60 Gy at 2 Gy/fx. The acceptable weekly chemotherapy regimens are Cisplatin 30 to 40 mg/m2 (first choice), Cetuximab 250mg/m2 (second choice), Carboplatin AUC 1.5 and paclitaxel 45 mg/m2 (third choice), Carboplatin AUC 3 (fourth choice). Chemotherapy will be given intravenously weekly during IMRT, 6 total doses. Chemotherapy will not be given to patients with T0-2 N0-1 disease, ≤ 10 pack years smoking history. Decision for surgical evaluation will be based on the results of the PET/CT and clinical exam 10-16 weeks after CRT. Patients with a positive PET/CT scan will undergo surgical evaluation at the discretion of the surgeon. Patients with a negative PET/CT scan will be observed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intensity Modulated Radiotherapy (IMRT)

2011

Completed Phase 2

~300

Cisplatin (or alternative)

2016

Completed Phase 2

~200