TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck
NCT ID: NCT03729518
Last Updated: 2025-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
150 participants
INTERVENTIONAL
2018-10-11
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
All patients will have the volume treated and radiation dose delivered to the regional lymphatics decreased according to the characteristics of the primary site and involved lymph nodes. The high risk neck will receive 50 Gy instead of 60 Gy, and the treated volume of the contralateral low risk neck will be reduced and receive only 45 Gy.
Radiation Therapy (IMRT or IMPT)
* Treatment of the primary tumor bed will be omitted in appropriate patients, as per the initial TORS de-intensification protocol. In those patients requiring treatment of the primary site, reduced dose (50 Gy) will be delivered.
* Receipt of concurrent chemotherapy per current guidelines. Chemotherapy may be omitted in patients with focal or microscopic ENE (defined as ≤ 1 mm ENE), at the discretion of the treating Medical Oncologist.
* Blood samples will be obtained at time of enrollment, and at two time points during RT, to quantify circulating HPV DNA and perform immune profiling.
Interventions
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Radiation Therapy (IMRT or IMPT)
* Treatment of the primary tumor bed will be omitted in appropriate patients, as per the initial TORS de-intensification protocol. In those patients requiring treatment of the primary site, reduced dose (50 Gy) will be delivered.
* Receipt of concurrent chemotherapy per current guidelines. Chemotherapy may be omitted in patients with focal or microscopic ENE (defined as ≤ 1 mm ENE), at the discretion of the treating Medical Oncologist.
* Blood samples will be obtained at time of enrollment, and at two time points during RT, to quantify circulating HPV DNA and perform immune profiling.
Eligibility Criteria
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Inclusion Criteria
* 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
* Presence of T4 disease
* Presence of N2c or N3 neck disease (per AJCC 7th Ed)
* \>= 5 lymph nodes
* Presence of distant metastatic disease
18 Years
ALL
No
Sponsors
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Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Weinstein GS, Quon H, O'Malley BW Jr, Kim GG, Cohen MA. Selective neck dissection and deintensified postoperative radiation and chemotherapy for oropharyngeal cancer: a subset analysis of the University of Pennsylvania transoral robotic surgery trial. Laryngoscope. 2010 Sep;120(9):1749-55. doi: 10.1002/lary.21021.
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Other Identifiers
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UPCC 15318
Identifier Type: -
Identifier Source: org_study_id
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