Clinical trial NCT03729518: TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck
Official title: A Phase II Study of Volume and Dose De-Intensification Following Transoral Robotic Surgery (TORS) and Neck Dissection for p16+ Oropharyngeal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Oropharyngeal Cancer
Squamous Cell Carcinoma
Human Papilloma Virus
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm Phase II study of adjuvant radiation for locally advanced p16+ oropharyngeal squamous cell carcinoma. The main purpose of this research is to determine the likelihood of cancer growing back in the throat or in the neck two years after completion of radiation if lower doses of radiation are used to a smaller area of the head and neck region than is currently used in standard of care.

Detailed description: This is a single arm Phase II study of adjuvant radiation for locally-advanced p16+ oropharyngeal squamous cell carcinoma. Patients with pT0-T3, N0-N2b, M0 disease (per AJCC 7th ed) with \<5 positive lymph nodes, will be eligible. Patients will have undergone TORS primary site resection and ipsilateral neck dissection. Patients will undergo radiation dose reduction and target volume reduction.

Eligibility criteria: Inclusion Criteria:

* Patients \>= 18 years old
* Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, p16-positive on immunohistochemistry
* Pathologic T0 (unknown primary), T1, T2, or T3 disease (per AJCC 7th Ed)
* Pathologic N0, N1, N2a, or N2b disease (per AJCC 7th Ed), with \< 5 positive lymph nodes
* ECOG Performance Status 0-1

Exclusion Criteria:

* Prior radiation therapy to the head and neck
* Presence of T4 disease
* Presence of N2c or N3 neck disease (per AJCC 7th Ed)
* \>= 5 lymph nodes
* Presence of distant metastatic disease

Primary outcomes:
measure: 2-year locoregional control
timeFrame: 2 years
Secondary outcomes:
measure: Treatment-related toxicity
timeFrame: 2 years
measure: 2-year progression-free survival
timeFrame: 3 years
measure: Differences in toxicity between Intensity-modulated radiation therapy (IMRT) and Intensity Modulated Proton Therapy (IMPT)
timeFrame: 1 year
measure: Number of participants with change in circulating human papillomavirus(HPV) DNA over the course of treatment
timeFrame: 2 years
measure: Metastasis-free survival
timeFrame: 3 years
measure: Patient reported quality of life outcomes
timeFrame: 2.5 years
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
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