Trial Outcomes & Findings for De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC: Follow-up Study (NCT NCT02281955)
NCT ID: NCT02281955
Last Updated: 2025-01-07
Results Overview
Progression Free Survival (PFS) was defined as the time from the beginning of treatment to cancer progression or death. The outcome measure will be reported as the proportion of patients with PFS at 2 years post-treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
115 participants
Primary outcome timeframe
Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks)
Results posted on
2025-01-07
Participant Flow
Enrolling institutions included University of North Carolina Hospitals (Chapel Hill, NC), University of Florida Hospitals (Gainesville, FL), Rex Hospital (Raleigh, NC), High Point Regional Health (High Point, NC), and Pardee Memorial Hospital (Hendersonville, NC).
115 patients were accrued. One patient voluntarily withdrew prior to treatment. One patient died during treatment secondary to neutropenic sepsis.
Participant milestones
| Measure |
De-escalated Radiation and Chemotherapy
All patients were treated with Intensity Modulated Radiotherapy (IMRT). The total dose to the high-risk regions was 60 Gy at 2 Gy per fraction, 30 fractions, 5 days a week, for 6 weeks. Fifty-four gray was delivered to anatomic regions at risk of subclinical disease as indicated. Unilateral radiotherapy was permitted in patients with well-lateralized tonsil primaries. Cisplatin 30 mg/m2 once per week was the mandated first-choice chemotherapy; however, alternative regimens once per week were permissible. Chemotherapy was given intravenously once per week, preferably on Mondays. Six weekly doses were given concurrently with radiation. Dose modifications were allowed as needed per the treating medical oncologist's discretion. If a patient could not tolerate cisplatin for more than 1 week, he or she was switched to an alternative regimen. Chemotherapy was not given to patients with T0-2 N0-1 disease (AJCC 7th edition).
|
|---|---|
|
Overall Study
STARTED
|
114
|
|
Overall Study
COMPLETED
|
113
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
De-escalated Radiation and Chemotherapy
All patients were treated with Intensity Modulated Radiotherapy (IMRT). The total dose to the high-risk regions was 60 Gy at 2 Gy per fraction, 30 fractions, 5 days a week, for 6 weeks. Fifty-four gray was delivered to anatomic regions at risk of subclinical disease as indicated. Unilateral radiotherapy was permitted in patients with well-lateralized tonsil primaries. Cisplatin 30 mg/m2 once per week was the mandated first-choice chemotherapy; however, alternative regimens once per week were permissible. Chemotherapy was given intravenously once per week, preferably on Mondays. Six weekly doses were given concurrently with radiation. Dose modifications were allowed as needed per the treating medical oncologist's discretion. If a patient could not tolerate cisplatin for more than 1 week, he or she was switched to an alternative regimen. Chemotherapy was not given to patients with T0-2 N0-1 disease (AJCC 7th edition).
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC: Follow-up Study
Baseline characteristics by cohort
| Measure |
De-escalated Radiation and Chemotherapy
n=114 Participants
All patients were treated with Intensity Modulated Radiotherapy (IMRT). The total dose to the high-risk regions was 60 Gy at 2 Gy per fraction, 30 fractions, 5 days a week, for 6 weeks. Fifty-four gray was delivered to anatomic regions at risk of subclinical disease as indicated. Unilateral radiotherapy was permitted in patients with well-lateralized tonsil primaries. Cisplatin 30 mg/m2 once per week was the mandated first-choice chemotherapy; however, alternative regimens once per week were permissible. Chemotherapy was given intravenously once per week, preferably on Mondays. Six weekly doses were given concurrently with radiation. Dose modifications were allowed as needed per the treating medical oncologist's discretion. If a patient could not tolerate cisplatin for more than 1 week, he or she was switched to an alternative regimen. Chemotherapy was not given to patients with T0-2 N0-1 disease (AJCC 7th edition).
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
104 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
114 participants
n=5 Participants
|
|
Marital Status
Married
|
90 Participants
n=5 Participants
|
|
Marital Status
Unmarried
|
23 Participants
n=5 Participants
|
|
Marital Status
Unknown
|
1 Participants
n=5 Participants
|
|
Tobacco Use
Never smoked
|
54 Participants
n=5 Participants
|
|
Tobacco Use
<= 10 pack-years
|
38 Participants
n=5 Participants
|
|
Tobacco Use
> 10 pack-years
|
22 Participants
n=5 Participants
|
|
Primary Tumor Location
Tonsil
|
52 Participants
n=5 Participants
|
|
Primary Tumor Location
Base of tongue
|
57 Participants
n=5 Participants
|
|
Primary Tumor Location
Unknown primary
|
5 Participants
n=5 Participants
|
|
T Stage
T0
|
5 Participants
n=5 Participants
|
|
T Stage
T1
|
35 Participants
n=5 Participants
|
|
T Stage
T2
|
61 Participants
n=5 Participants
|
|
T Stage
T3
|
13 Participants
n=5 Participants
|
|
N Stage (AJCC 7th edition)
N0
|
18 Participants
n=5 Participants
|
|
N Stage (AJCC 7th edition)
N1
|
16 Participants
n=5 Participants
|
|
N Stage (AJCC 7th edition)
N2a
|
5 Participants
n=5 Participants
|
|
N Stage (AJCC 7th edition)
N2b
|
57 Participants
n=5 Participants
|
|
N Stage (AJCC 7th edition)
N2c
|
18 Participants
n=5 Participants
|
|
N Stage (AJCC 8th edition)
N0
|
18 Participants
n=5 Participants
|
|
N Stage (AJCC 8th edition)
N1
|
78 Participants
n=5 Participants
|
|
N Stage (AJCC 8th edition)
N2
|
18 Participants
n=5 Participants
|
|
HPV/p16 Status
HPV+/p16+
|
46 Participants
n=5 Participants
|
|
HPV/p16 Status
HPV-/p16+
|
12 Participants
n=5 Participants
|
|
HPV/p16 Status
HPV unknown/p16+
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks)Progression Free Survival (PFS) was defined as the time from the beginning of treatment to cancer progression or death. The outcome measure will be reported as the proportion of patients with PFS at 2 years post-treatment.
Outcome measures
| Measure |
De-escalated Radiation and Chemotherapy
n=112 Participants
All patients were treated with Intensity Modulated Radiotherapy (IMRT). The total dose to the high-risk regions was 60 Gy at 2 Gy per fraction, 30 fractions, 5 days a week, for 6 weeks. Fifty-four gray was delivered to anatomic regions at risk of subclinical disease as indicated. Unilateral radiotherapy was permitted in patients with well-lateralized tonsil primaries. Cisplatin 30 mg/m2 once per week was the mandated first-choice chemotherapy; however, alternative regimens once per week were permissible. Chemotherapy was given intravenously once per week, preferably on Mondays. Six weekly doses were given concurrently with radiation. Dose modifications were allowed as needed per the treating medical oncologist's discretion. If a patient could not tolerate cisplatin for more than 1 week, he or she was switched to an alternative regimen. Chemotherapy was not given to patients with T0-2 N0-1 disease (AJCC 7th edition).
|
|---|---|
|
2 Year Progression Free Survival After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)
|
99 Participants
|
SECONDARY outcome
Timeframe: Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks).The outcome measure will be reported as the proportion of patients with LC at 2 years post-treatment.
Outcome measures
| Measure |
De-escalated Radiation and Chemotherapy
n=111 Participants
All patients were treated with Intensity Modulated Radiotherapy (IMRT). The total dose to the high-risk regions was 60 Gy at 2 Gy per fraction, 30 fractions, 5 days a week, for 6 weeks. Fifty-four gray was delivered to anatomic regions at risk of subclinical disease as indicated. Unilateral radiotherapy was permitted in patients with well-lateralized tonsil primaries. Cisplatin 30 mg/m2 once per week was the mandated first-choice chemotherapy; however, alternative regimens once per week were permissible. Chemotherapy was given intravenously once per week, preferably on Mondays. Six weekly doses were given concurrently with radiation. Dose modifications were allowed as needed per the treating medical oncologist's discretion. If a patient could not tolerate cisplatin for more than 1 week, he or she was switched to an alternative regimen. Chemotherapy was not given to patients with T0-2 N0-1 disease (AJCC 7th edition).
|
|---|---|
|
2 Year Local Control (LC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)
|
107 Participants
|
SECONDARY outcome
Timeframe: Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks).The outcome measure will be reported as the proportion of patients with RC at 2 years post-treatment.
Outcome measures
| Measure |
De-escalated Radiation and Chemotherapy
n=112 Participants
All patients were treated with Intensity Modulated Radiotherapy (IMRT). The total dose to the high-risk regions was 60 Gy at 2 Gy per fraction, 30 fractions, 5 days a week, for 6 weeks. Fifty-four gray was delivered to anatomic regions at risk of subclinical disease as indicated. Unilateral radiotherapy was permitted in patients with well-lateralized tonsil primaries. Cisplatin 30 mg/m2 once per week was the mandated first-choice chemotherapy; however, alternative regimens once per week were permissible. Chemotherapy was given intravenously once per week, preferably on Mondays. Six weekly doses were given concurrently with radiation. Dose modifications were allowed as needed per the treating medical oncologist's discretion. If a patient could not tolerate cisplatin for more than 1 week, he or she was switched to an alternative regimen. Chemotherapy was not given to patients with T0-2 N0-1 disease (AJCC 7th edition).
|
|---|---|
|
2 Year Regional Control (RC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)
|
110 Participants
|
SECONDARY outcome
Timeframe: Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks).The outcome measure will be reported as the proportion of patients with LRC at 2 years post-treatment.
Outcome measures
| Measure |
De-escalated Radiation and Chemotherapy
n=111 Participants
All patients were treated with Intensity Modulated Radiotherapy (IMRT). The total dose to the high-risk regions was 60 Gy at 2 Gy per fraction, 30 fractions, 5 days a week, for 6 weeks. Fifty-four gray was delivered to anatomic regions at risk of subclinical disease as indicated. Unilateral radiotherapy was permitted in patients with well-lateralized tonsil primaries. Cisplatin 30 mg/m2 once per week was the mandated first-choice chemotherapy; however, alternative regimens once per week were permissible. Chemotherapy was given intravenously once per week, preferably on Mondays. Six weekly doses were given concurrently with radiation. Dose modifications were allowed as needed per the treating medical oncologist's discretion. If a patient could not tolerate cisplatin for more than 1 week, he or she was switched to an alternative regimen. Chemotherapy was not given to patients with T0-2 N0-1 disease (AJCC 7th edition).
|
|---|---|
|
2 Year Local-regional Control (LRC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)
|
105 Participants
|
SECONDARY outcome
Timeframe: Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks).The outcome measure will be reported as the proportion of patients with DMFS at 2 years post-treatment.
Outcome measures
| Measure |
De-escalated Radiation and Chemotherapy
n=112 Participants
All patients were treated with Intensity Modulated Radiotherapy (IMRT). The total dose to the high-risk regions was 60 Gy at 2 Gy per fraction, 30 fractions, 5 days a week, for 6 weeks. Fifty-four gray was delivered to anatomic regions at risk of subclinical disease as indicated. Unilateral radiotherapy was permitted in patients with well-lateralized tonsil primaries. Cisplatin 30 mg/m2 once per week was the mandated first-choice chemotherapy; however, alternative regimens once per week were permissible. Chemotherapy was given intravenously once per week, preferably on Mondays. Six weekly doses were given concurrently with radiation. Dose modifications were allowed as needed per the treating medical oncologist's discretion. If a patient could not tolerate cisplatin for more than 1 week, he or she was switched to an alternative regimen. Chemotherapy was not given to patients with T0-2 N0-1 disease (AJCC 7th edition).
|
|---|---|
|
2 Year Distant Metastasis Free Survival (DMFS) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)
|
103 Participants
|
SECONDARY outcome
Timeframe: Two years after completion of CRT on last enrolled patient (Note: CRT duration is 6 weeks).Population: Note that the count provided here represents actuarial data and thus does not match the all-cause mortality count in the Adverse Events module.
The outcome measure will be reported as the proportion of patients who are still alive (overall survival) at 2 years post-treatment.
Outcome measures
| Measure |
De-escalated Radiation and Chemotherapy
n=114 Participants
All patients were treated with Intensity Modulated Radiotherapy (IMRT). The total dose to the high-risk regions was 60 Gy at 2 Gy per fraction, 30 fractions, 5 days a week, for 6 weeks. Fifty-four gray was delivered to anatomic regions at risk of subclinical disease as indicated. Unilateral radiotherapy was permitted in patients with well-lateralized tonsil primaries. Cisplatin 30 mg/m2 once per week was the mandated first-choice chemotherapy; however, alternative regimens once per week were permissible. Chemotherapy was given intravenously once per week, preferably on Mondays. Six weekly doses were given concurrently with radiation. Dose modifications were allowed as needed per the treating medical oncologist's discretion. If a patient could not tolerate cisplatin for more than 1 week, he or she was switched to an alternative regimen. Chemotherapy was not given to patients with T0-2 N0-1 disease (AJCC 7th edition).
|
|---|---|
|
2 Year Overall Survival (OS) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)
|
106 Participants
|
Adverse Events
De-escalated Radiation and Chemotherapy
Serious events: 0 serious events
Other events: 59 other events
Deaths: 5 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
De-escalated Radiation and Chemotherapy
n=114 participants at risk
All patients were treated with Intensity Modulated Radiotherapy (IMRT). The total dose to the high-risk regions was 60 Gy at 2 Gy per fraction, 30 fractions, 5 days a week, for 6 weeks. Fifty-four gray was delivered to anatomic regions at risk of subclinical disease as indicated. Unilateral radiotherapy was permitted in patients with well-lateralized tonsil primaries. Cisplatin 30 mg/m2 once per week was the mandated first-choice chemotherapy; however, alternative regimens once per week were permissible. Chemotherapy was given intravenously once per week, preferably on Mondays. Six weekly doses were given concurrently with radiation. Dose modifications were allowed as needed per the treating medical oncologist's discretion. If a patient could not tolerate cisplatin for more than 1 week, he or she was switched to an alternative regimen. Chemotherapy was not given to patients with T0-2 N0-1 disease (AJCC 7th edition).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.88%
1/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.88%
1/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Metabolism and nutrition disorders
Anorexia
|
22.8%
26/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Psychiatric disorders
Anxiety
|
2.6%
3/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.88%
1/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.4%
5/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Psychiatric disorders
Depression
|
0.88%
1/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
2.6%
3/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Gastrointestinal disorders
Dry mouth
|
2.6%
3/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Gastrointestinal disorders
Dysphagia
|
21.9%
25/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Gastrointestinal disorders
Esophagitis
|
0.88%
1/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
General disorders
Fatigue
|
4.4%
5/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.88%
1/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
General disorders
Fever
|
0.88%
1/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
0.88%
1/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.88%
1/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.88%
1/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.8%
2/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.8%
2/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Vascular disorders
Hypotension
|
0.88%
1/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Gastrointestinal disorders
Mucositis oral
|
18.4%
21/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
24.6%
28/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.88%
1/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Gastrointestinal disorders
Nausea
|
9.6%
11/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
General disorders
Neck edema
|
0.88%
1/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Infections and infestations
Sepsis
|
1.8%
2/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
General disorders
Pain
|
13.2%
15/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Gastrointestinal disorders
Oral pain
|
0.88%
1/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.8%
2/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Nervous system disorders
Syncope
|
0.88%
1/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders - Other, specify
|
0.88%
1/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
2/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
4/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
|
Investigations
Weight loss
|
2.6%
3/114 • 2 years post-treatment
Only Grade 3 and higher events were collected across all sites and are reported here.
|
Additional Information
Dr. Colette Shen
University of North Carolina at Chapel Hill
Phone: 984-974-0400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place