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TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck

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ClinicalTrials.gov Identifier: NCT03729518
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Oropharyngeal Cancer Squamous Cell Carcinoma Human Papilloma Virus Radiation: Radiation Therapy (IMRT or IMPT) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 11, 2018
Estimated Primary Completion Date : October 11, 2022
Estimated Study Completion Date : October 11, 2024

Arm Intervention/treatment
Experimental: 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: 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.




Primary Outcome Measures :
  1. 2-year locoregional control [ Time Frame: 2 years ]
    Number of patients with 2-year locoregional control, defined as control at the primary site and in the neck, in patients undergoing de-intensified radiation to the primary site and regional lymphatics after Transoral Robotic Surgery (TORS) and neck dissection for p16+ oropharyngeal squamous cell carcinoma (OPSCC)


Secondary Outcome Measures :
  1. Treatment-related toxicity [ Time Frame: 2 years ]
    Number of participants with treatment-related toxicity as gauged by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. the CTCAE v.5 utilizes a five point scale to report Adverse Events (AEs), defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of medical treatment or procedure that may or may not be considered related to the medical treatment or procedure (cancer.gov)

  2. 2-year progression-free survival [ Time Frame: 3 years ]
    Number of participants with 2-year progression-free survival, defined as the length of time during and after treatment that a patient lives with the disease but it does not get worse (nih.gov)

  3. Differences in toxicity between Intensity-modulated radiation therapy (IMRT) and Intensity Modulated Proton Therapy (IMPT) [ Time Frame: 1 year ]
    Differences in toxicity outcomes in patients treated with IMRT versus proton therapy

  4. Number of participants with change in circulating human papillomavirus(HPV) DNA over the course of treatment [ Time Frame: 2 years ]
    Number of patients with a change in circulating HPV cells during the course of treatment, determined using a next generation sequencing (NGS) assay developed to detect HPV DNA in HPV+ oropharyngeal squamous cell carcinoma patients.

  5. Metastasis-free survival [ Time Frame: 3 years ]
    Number of participants with metastasis-free survival

  6. Patient reported quality of life outcomes [ Time Frame: 2.5 years ]
    Patient reported quality of life (QOL) outcomes using MD Anderson Symptom Inventory (MDASI) Head and Neck survey between patients treated with IMRT and IMPT. The MDASI-HN assesses the severity of symptoms in the last 24 hours using a 0-10 scale, with 0 being "not present" and 10 being "as bad as you can imagine". The interference of symptoms in the last 24 hours is assessed using a 0-10 scale, with 0 being "did not interfere" and 10 being "interfered completely". The mean of symptom severity and interference can be used to represent overall symptom distress and can be analyzed for changes over treatment and during follow-up.

  7. Overall survival [ Time Frame: 5 years ]
    Number of patients with overall survival, as defined by the length of time from the date of diagnosis or start of treatment for a disease that patients diagnosed with the disease are still alive (cancer.gov)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729518


Contacts
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Contact: J. Nicholas Lukens, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania

Publications:
ClinicalTrials.gov. Post-operative Adjuvant Treatment for HPV-positive Tumours (PATHOS).
J. Gershowitz AD, J.N. Lukens, S.D. Swisher-McClure, G.A. Geiger Jr., A. Lin. Pathologic Risk Factors Associated With Contralateral Neck Disease in Patients with Tonsil Cancer: Implications on Patient Selection for Unilateral Neck Radiation Therapy. International Journal of Radiation Oncology Biology Physics. 2017;99(2):S234.
H.B. Musunuru PY, H.C. Ko, T. Kennedy, P.M. Harari, M.E. Witek. Can Elective Neck Radiation Treatment Volumes be Safely Reduced to Diminish Toxicity Profiles for Oropharynx Cancer Patients? International journal of radiation oncology, biology, physics. 2017;99(2 Supplement):E361.
J.C. Rwigema JAL, H.P. van der Laan, J.N. Lukens, S.D. Swisher-McClure, A. Lin. Proton Therapy Improves Toxicity for Oropharyngeal Cancer: An Outcomes and Predictive Model-based Approach. International journal of radiation oncology, biology, physics. 2017;99(2 Supplement):S135-S6.
P. Ahn SS, O. Zhou, J.N. Lukens, A. Lin. A Comparative Quality of Life Cohort of Oropharyngeal Squamous Cell (OPSCC) Patients Treated With Volumetric Modulated Radiation Therapy (VMAT) Versus Proton Pencil Beam Scanning (PBS). International journal of radiation oncology, biology, physics. 2016;93(3 Supp):S71.
Society AC. Cancer Facts and Figures 2011. 2011.

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03729518    
Other Study ID Numbers: 831188-15318
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Papilloma
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases