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Alkylating agents

Chemotherapy + Reduced-Dose Radiation for Throat Cancer (ENID Trial)

Phase 2

Recruiting

Led By Gregory Biedermann, MD

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

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

Must have

Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage).

Serum creatinine < 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min

Must not have

T1-T2 N0-1 lateralized squamous cell carcinoma of the tonsil.

Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administering lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer.

Who is the study for?

This trial is for low-risk patients with HPV-positive oropharyngeal cancer who have not had prior invasive malignancies (except certain skin cancers) in the last 5 years, no previous radiotherapy overlapping the study area, and no chemotherapy for their current cancer. They must be generally healthy, non-heavy smokers or willing to quit, and women of childbearing age should use contraception.

What is being tested?

The trial tests if giving standard dose chemotherapy alongside radiation therapy directly to areas affected by HPV-positive oropharyngeal cancer—and lower doses to unaffected lymph nodes—can control the disease while reducing long-term side effects and improving life quality after treatment.

What are the potential side effects?

Potential side effects include those commonly associated with radiation therapy such as fatigue, skin reactions at the treated site, difficulty swallowing, dry mouth; and from Cisplatin injection like nausea, kidney issues, hearing problems and nerve damage.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with a specific type of throat cancer.

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My kidney function is normal, with creatinine levels below 1.5 mg/dl or clearance above 50 ml/min.

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I have had a CT scan of my neck with contrast and a chest CT scan.

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My cancer tissue tested positive for p16.

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My cancer is in stages T1-T3, N0-N2, and has not spread far.

Exclusion Criteria

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

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My cancer is in the early stages and located in my tonsil.

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My cancer originates from the mouth, nasopharynx, hypopharynx, or larynx.

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I've had surgery to remove all visible cancer from the primary site and lymph nodes.

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I do not have an active bacterial or fungal infection needing IV antibiotics.

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I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.

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I have not had radiation in the same area where my current cancer is.

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I have a neck carcinoma with an unknown primary origin.

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I haven't been hospitalized for COPD or other lung issues in the last 30 days.

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My cancer has spread to lymph nodes that are larger than 6 cm.

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I have more than one primary cancer or tumors in both sides of a body part.

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My cancer has spread to the lymph nodes near my collarbone.

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My scans show cancer has spread below my collarbone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 and 2 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 and 2 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 and 2 years post treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rate of PEG tube placement

Secondary study objectives

Dysphagia index

Hypothyroidism incidence

Patient Reported Outcomes

+3 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: Open label single-arm studyExperimental Treatment1 Intervention

All patients will receive concurrent cisplatin and radiation therapy with radiation dose de-escalation to clinically and radiologically uninvolved lymph nodes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin injection

2014

Completed Phase 3

~100

0 / 17Eligibility criteria met