TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Cancer, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/4/2018 |
| Start Date: | October 11, 2018 |
| End Date: | October 11, 2024 |
| Contact: | J. Nicholas Lukens, MD |
| Email: | PennCancerTrials@emergingmed.com |
| Phone: | 855-216-0098 |
A Phase II Study of Volume and Dose De-Intensification Following Transoral Robotic Surgery (TORS) and Neck Dissection for p16+ Oropharyngeal Squamous Cell Carcinoma
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.
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.
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.
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.
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
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