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Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer

ConditionOropharynx Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFox Chase Cancer Center

About this trial

This is a prospective, phase II, stratified single arm investigation for favorable prognosis in p16+ oropharynx cancer patients with either node negative or malignant neck adenopathy with lymphoscintigraphy mapping confined to the ipsilateral neck.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed squamous cell carcinoma of the oropharynx

Nodal status (based on staging manual, AJCC (American Joint Committee on Cancer) 8th ed.): N0 (provided the tumor is within 1cm of midline) N1> 1 lymph nodes (on the same side of the neck as the primary cancer) or cN3 (cranial nerve III) with no contralateral neck adenopathy

Tumor stage T1-2 that approaches within 1 cm but does not cross midline as appreciated radiographically and/or by the treating radiation oncologist or a head and neck surgeon

CT with contrast and/or MRI with contrast performed within 56 days prior to registration that does not demonstrate bilateral neck adenopathy. In the setting of medical contraindication to both CT and MRI contrast please contact the study PI

Disqualifiers

Tumors that cross midline, regardless of T stage

N2 adenopathy (bilateral neck adenopathy)

Gross total excision of the primary site in a diagnostic procedure prior to either imaging and/or physical examination by registering physician.

p16-negative squamous cell carcinoma

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiation therapy (5 days for 7 weeks)

    Radiation

    Mon-Fri (5 days for 7 weeks), total 35 fractions over 35 treatment days of radiation therapy (RT)

  • Radiation therapy (5 days for 6 weeks)

    Radiation

    Mon-Fri (5 days for 6 weeks), total 35 fractions over 30 treatment days of RT (two doses 6 hours apart except for the last 6th Friday of the 6 weeks )

  • Cisplatin

    Drug

    Cisplatin, 40mg/m2 (weekly for 7 weeks)

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: Cohort A (>N1 or single node > 3cm )Experimental treatment 2 interventions
Group B: Cohort B (N0 or N1 <3cm)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients that develop cancer on the contra-lateral side of the neck within 12 months of completion of radiation treatment

To evaluate the development of cancer on the contra-lateral side of the neck within 12 months of completion of radiation treatment.

Time frame
1 year

Secondary outcomes

1

Level of xerostomia

To evaluate whether the omission of elective radiation to the contralateral neck decrease patient reported xerostomia at 6, 12, and 24 months to a mean score of 47.2 (from an expected 57.2) as measured by the European Organization for Research and Treatment of Cancer (EORTC) QLQ H\&N35

Time frame
2 years
2

Mean swallowing change (modified barium swallowing test)

To evaluate the functional swallowing change of patients treated with unilateral neck radiation as measured by a modified barium swallow for the period of one year after the end of radiotherapy. The investigators will use summary statistics such as changes in means and changes in proportions to evaluate the functional swallowing change of patients treated with unilateral neck radiation as measured by a modified barium swallow test.

Time frame
2 years
3

Mean swallowing change (patient reported)

To evaluate patient reported swallowing of patients treated with unilateral neck radiation as measured by the EORTC QLQ H\&N 35 for the period of two years after the end of radiotherapy. The investigators will use summary statistics to characterize changes in means of reported swallowing for patients treated with unilateral neck radiation as measured by the EORTC QLQ H\&N 35. The investigators will use sign-rank tests to investigate if the changes are equal to zero.

Time frame
2 years
4

Rate of contralateral neck progression

To evaluate the development of cancer on the contra-lateral side of the neck within 24 months of completion of radiation treatment. The investigators will use cumulative incidence curves and Fine and Gray proportional hazards regressions to characterize the rate of contralateral neck progression for the period of 2 years after the completion of radiation. In this analysis, death will be considered a competing risk.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fox Chase Cancer Center

Lead sponsor

Cardinal Health

Collaborator

Source ClinicalTrials.gov
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