Health TrialsbyHealthPanel

De-escalation of Adjuvant Radiation for Low-Risk HPV Oropharyngeal Cancers

ConditionOropharynx Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeorgetown University

About this trial

The goal of this clinical trial is to learn whether for intermediate-risk patients who have undergone Transoral Robotic Surgery for HPV/p16(+) oropharyngeal cancer and have minimal smoking history, whether these patients can be treated with a lower-than standard dose, with omission of the primary site in the oropharynx. The main questions it aims to answer are:

Does radiotherapy site and dose-de-escalation lead to similar outcomes compared to historical data on tumor control in patients who are treated with standard radiation doses and treatment fields?

Participants will:

Undergo treatment with a lower than standard radiation dose (50Gy in 25 fractions, with either Intensity Modulated Radiation Therapy (IMRT) or proton beam therapy) and to a smaller than standard radiation field (to the neck only, excluding the original site of tumor in the oropharynx)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients must be ≥ 18 years of age on the day of signing informed consent.

Patients must have a diagnosis of p16+ and/or HPV+ squamous cell carcinoma of the oropharynx (including base of tongue, glossotonsilar sulcus, tonsil, soft palate, vallecula, and/or posterior oropharyngeal wall).

pathologic stage T1-2 N1 M0 (AJCC 8th ed.) stage I or T3 N0-1 M0 stage II (AJCC 8th ed.) SCCA of the oropharynx, with ≤ 5 distinct nodes involved with tumor, ≤ 2mm ECE (extracapsular extension), ≥ 2mm surgical margins at primary site.

Karnofsky Performance Status (KPS) ≥ 60 within 8 weeks prior to registration.

Disqualifiers

Perineural invasion at primary site

Lymphovascular space invasion at primary site

Level 4 nodal involvement (even if resected)

Retropharyngeal nodal involvement (even if resected)

Trial design

Design model

Single group

Treatments tested in this trial

  • Radiation Therapy

    Radiation

    De-escalation of Adjuvant Radiotherapy

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Radiation dose: 50GyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

2 year progression free survival, as determined by standard of care physical examination and standard of care surveillance imaging.

Time frame
2 year

Secondary outcomes

1

Quality of Life (QOL)

Quality of Life will be measured by validated questionnaires relating to Patient Related Outcomes (EORTC QLQ-C30 (version 3). Completed at baseline (at radiotherapy consult), and then approximately at 1-2 weeks, 3 months, 6, 12, 18 and 24 months after completion of RT. A high scale score represents a higher response level.

Time frame
2 year
2

Local Control Rate

Local Control as determined by standard of care physical examination and standard of care surveillance imaging.

Time frame
2 year
3

Regional Control Rate

Regional Control as determined by standard of care physical examination and standard of care surveillance imaging

Time frame
2 year
4

Distant Metastasis-Free Survival (DMFS)

Distant Metastasis-Free Survival as determined by standard of care physical examination and standard of care surveillance imaging.

Time frame
2 year

Other outcomes

Sponsors and contacts

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

Georgetown University

Lead sponsor

MedStar Georgetown University Hospital

Collaborator

Source ClinicalTrials.gov
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