De-intensification of Radiation & Chemotherapy in Low-Risk Human Papillomavirus-related Oropharyngeal Squamous Cell Ca
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ClinicalTrials.gov Identifier: NCT01530997 |
Recruitment Status :
Active, not recruiting
First Posted : February 10, 2012
Results First Posted : August 9, 2017
Last Update Posted : March 9, 2020
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Carcinoma, Squamous Cell Head and Neck Neoplasms Oropharyngeal Neoplasms |
Interventions |
Radiation: Intensity Modulated Radiotherapy (IMRT) Drug: Cisplatin Procedure: Limited surgical evaluation |
Enrollment | 45 |
Recruitment Details | Enrolling institutions included University of North Carolina Hospitals (Chapel Hill, NC), University of Florida Hospitals (Gainesville, FL), and Rex Hospital (Raleigh, NC). |
Pre-assignment Details | Sixty-nine patients were eligible for enrollment, of whom 45 were accrued. One patient had a cerebrovascular accident during de-intensified CRT and was taken off the study. After the completion of CRT, 1 patient refused the planned surgical evaluation, leaving 43 patients who were fully evaluable. |
Arm/Group Title | Single Intervention |
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Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively. |
Period Title: Overall Study | |
Started | 45 |
Completed | 43 |
Not Completed | 2 |
Reason Not Completed | |
Physician Decision | 1 |
Withdrawal by Subject | 1 |
Arm/Group Title | De-escalated Radiation and Chemotherapy | |
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Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively. |
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Overall Number of Baseline Participants | 44 | |
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Sixty-nine patients were eligible for enrollment, of whom 45 were accrued. One patient had a cerebrovascular accident during de-intensified CRT and was taken off the study leaving 44 patients included in the baseline characteristics.
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Age, Continuous
Mean (Full Range) Unit of measure: Years |
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Number Analyzed | 44 participants | |
61
(44 to 76)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 44 participants | |
Female |
39 88.6%
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Male |
5 11.4%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 44 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
4 9.1%
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White |
40 90.9%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 44 participants |
44 | ||
Marital Status
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 44 participants | |
Married |
34 77.3%
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Unmarried |
10 22.7%
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Tobacco Use
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 44 participants | |
Never Smoker |
36 81.8%
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<=10 Pack Years |
6 13.6%
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> 10 Pack Years |
2 4.5%
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Primary Tumor Location
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 44 participants | |
Tonsil |
16 36.4%
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Base of Tongue |
26 59.1%
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Unknown Primary |
2 4.5%
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T Stage
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 44 participants | |
T0 |
2 4.5%
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T1 |
13 29.5%
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T2 |
22 50.0%
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T3 |
7 15.9%
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[1]
Measure Description: The Classification of Malignant Tumours (TNM) system is the most widely used cancer staging system. The T refers to the size and extent of the main tumor. N refers to the regional lymph nodes. N0 means there is no cancer in nearby lymph nodes. The larger the number following N means the more lymph nodes that contain cancer.
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N Stage
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 44 participants | |
N0 |
4 9.1%
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N1 |
10 22.7%
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N2a |
2 4.5%
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N2b |
21 47.7%
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N2c |
7 15.9%
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[1]
Measure Description: The Classification of Malignant Tumours (TNM) system is the most widely used cancer staging system. The T refers to the size and extent of the main tumor. N refers to the regional lymph nodes. N0 means there is no cancer in nearby lymph nodes. The larger the number following N means the more lymph nodes that contain cancer.
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HPV/p16 Status
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 44 participants | |
HPV+/p16+ |
28 63.6%
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HPV-/p16+ |
16 36.4%
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[1]
Measure Description: Human papilloma virus (HPV) is a common virus that can cause cancer. p16 is a tumor suppression gene that acts as a cyclin-dependent kinase inhibitor. HPV-related cancers with p16 overexpression (p16+) have a better prognosis than those not related to HPV due to an increased sensitivity to radiotherapy.
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Name/Title: | Robin V. Johnson |
Organization: | UNC Lineberger Comprehensive Cancer Center |
Phone: | 919-966-1125 |
EMail: | Robin_V_Johnson@med.unc.edu |
Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT01530997 |
Other Study ID Numbers: |
LCCC 1120 |
First Submitted: | January 20, 2012 |
First Posted: | February 10, 2012 |
Results First Submitted: | March 30, 2017 |
Results First Posted: | August 9, 2017 |
Last Update Posted: | March 9, 2020 |