Trial Outcomes & Findings for De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer (NCT NCT03952585)

Last Updated: 2025-10-31

Results Overview

Progression is defined as local-regional progression or recurrence, distant metastasis, death due to any reason, salvage surgery of primary with tumor present/unknown, salvage neck dissection with tumor present/unknown, \> 20 weeks from end of radiation therapy. Progression-free survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis. The primary phase IIR endpoint is tested using a confidence interval (CI) approach with each experimental arm compared to the standard arm (Arm 1).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2/PHASE3

Target enrollment

384 participants

Primary outcome timeframe

From randomization to first progression or last follow-up. Maximum follow-up at the time of analysis was 4.6 years. The 1- and 2-year estimates are reported.

Results posted on

2025-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Standard RT + Cisplatin) Patients undergo standard dose RT as 70 Gy IMRT or IGRT over 6 fractions per week and receive 100 mg/m\^2/day cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.	Arm II (Reduced RT+ Cisplatin) Patients undergo reduced dose RT as 60 Gy IMRT or IGRT QD over 5 fractions per week and receive 100 mg/m\^2/day cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.	Arm III (Reduced RT + Nivolumab) Beginning 1 week prior to radiation, patients receive 240 mg fixed dose nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks (14 days) for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo reduced dose RT as 60 Gy IMRT or IGRT over 6 fractions per week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.
Overall Study STARTED	136	116	132
Overall Study Adverse Event Populaton	123	112	123
Overall Study COMPLETED	136	116	132
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Standard RT + Cisplatin) n=136 Participants Patients undergo standard dose RT as 70 Gy IMRT or IGRT over 6 fractions per week and receive 100 mg/m\^2/day cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.	Arm II (Reduced RT+ Cisplatin) n=116 Participants Patients undergo reduced dose RT as 60 Gy IMRT or IGRT QD over 5 fractions per week and receive 100 mg/m\^2/day cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.	Arm III (Reduced RT + Nivolumab) n=132 Participants Beginning 1 week prior to radiation, patients receive 240 mg fixed dose nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks (14 days) for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo reduced dose RT as 60 Gy IMRT or IGRT over 6 fractions per week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.	Total n=384 Participants Total of all reporting groups
Stage group, clinical (AJCC 8) III (T0-3, N3, M0)	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Age, Continuous	60 years n=5 Participants	61 years n=7 Participants	60.5 years n=5 Participants	60 years n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants	36 Participants n=4 Participants
Sex: Female, Male Male	124 Participants n=5 Participants	105 Participants n=7 Participants	119 Participants n=5 Participants	348 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	20 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	124 Participants n=5 Participants	104 Participants n=7 Participants	120 Participants n=5 Participants	348 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) White	118 Participants n=5 Participants	102 Participants n=7 Participants	116 Participants n=5 Participants	336 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	19 Participants n=4 Participants
Zubrod performance status 0	118 Participants n=5 Participants	102 Participants n=7 Participants	117 Participants n=5 Participants	337 Participants n=4 Participants
Zubrod performance status 1	18 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants	47 Participants n=4 Participants
Smoking history Never	108 Participants n=5 Participants	93 Participants n=7 Participants	104 Participants n=5 Participants	305 Participants n=4 Participants
Smoking history Former	28 Participants n=5 Participants	22 Participants n=7 Participants	28 Participants n=5 Participants	78 Participants n=4 Participants
Smoking history Current	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Pack-years 0	109 Participants n=5 Participants	93 Participants n=7 Participants	104 Participants n=5 Participants	306 Participants n=4 Participants
Pack-years >0 to ≤10	27 Participants n=5 Participants	23 Participants n=7 Participants	28 Participants n=5 Participants	78 Participants n=4 Participants
Primary tumor site Oropharynx NOS	16 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	38 Participants n=4 Participants
Primary tumor site Tonsillar fossa, tonsil	68 Participants n=5 Participants	55 Participants n=7 Participants	65 Participants n=5 Participants	188 Participants n=4 Participants
Primary tumor site Base of tongue	51 Participants n=5 Participants	46 Participants n=7 Participants	54 Participants n=5 Participants	151 Participants n=4 Participants
Primary tumor site Pharyngeal oropharynx	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
p16-positive status	136 Participants n=5 Participants	116 Participants n=7 Participants	132 Participants n=5 Participants	384 Participants n=4 Participants
T stage, clinical (AJCC 8) T0	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
T stage, clinical (AJCC 8) T1	50 Participants n=5 Participants	39 Participants n=7 Participants	51 Participants n=5 Participants	140 Participants n=4 Participants
T stage, clinical (AJCC 8) T2	68 Participants n=5 Participants	57 Participants n=7 Participants	61 Participants n=5 Participants	186 Participants n=4 Participants
T stage, clinical (AJCC 8) T3	17 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	57 Participants n=4 Participants
N stage, clinical (AJCC 8) N0	5 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants
N stage, clinical (AJCC 8) N1	131 Participants n=5 Participants	112 Participants n=7 Participants	126 Participants n=5 Participants	369 Participants n=4 Participants
N stage, clinical (AJCC 8) N2	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
N stage, clinical (AJCC 8) N3	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
M stage M0, clinical (AJCC 8)	136 Participants n=5 Participants	116 Participants n=7 Participants	132 Participants n=5 Participants	384 Participants n=4 Participants
Stage group, clinical (AJCC 8) I (T0-2,N0-1,M0)	119 Participants n=5 Participants	96 Participants n=7 Participants	111 Participants n=5 Participants	326 Participants n=4 Participants
Stage group, clinical (AJCC 8) II (T0-2,N2,M0 or T3,N0-2,M0)	17 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	57 Participants n=4 Participants

PRIMARY outcome

Timeframe: From randomization to first progression or last follow-up. Maximum follow-up at the time of analysis was 4.6 years. The 1- and 2-year estimates are reported.

Population: Randomized phase II participants

Outcome measures

Outcome measures
Measure	Arm I (Standard RT + Cisplatin) n=136 Participants Patients undergo standard dose RT as 70 Gy IMRT or IGRT over 6 fractions per week and receive 100 mg/m\^2/day cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.	Arm II (Reduced RT+ Cisplatin) n=116 Participants Patients undergo reduced dose RT as 60 Gy IMRT or IGRT QD over 5 fractions per week and receive 100 mg/m\^2/day cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.	Arm III (Reduced RT + Nivolumab) n=132 Participants Beginning 1 week prior to radiation, patients receive 240 mg fixed dose nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks (14 days) for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo reduced dose RT as 60 Gy IMRT or IGRT over 6 fractions per week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.
Progression-free Survival (PFS) (Phase II) (Percentage of Participants Alive Without Progression) 1 year	99.1 percentage of participants Interval 97.3 to 100.0	96.4 percentage of participants Interval 93.0 to 99.9	96.6 percentage of participants Interval 93.4 to 99.9
Progression-free Survival (PFS) (Phase II) (Percentage of Participants Alive Without Progression) 2 years	98.1 percentage of participants Interval 95.4 to 100.0	88.6 percentage of participants Interval 82.4 to 94.7	90.3 percentage of participants Interval 84.5 to 96.1

PRIMARY outcome

Timeframe: From randomization to first progression or last follow-up. Maximum follow-up was 4.6 years.

Population: Randomized phase III participants. (Phase III component did not and will not open.)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline to two years

Population: Randomized phase III participants. (Phase III component did not and will not open.)

The M. D. Anderson Dysphagia Inventory (MDADI) assesses how patients view their swallowing ability as a result of treatment and how this affects their QOL. It consists of a global quality of life question and a functional, emotional, and physical subscale. The global QOL question ranges from 1 to 5 and multiplied by 20 to obtain a score with a range of 0 to 100. Higher scores indicate better functioning.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization to first failure, competing event, or last known follow-up, whichever occurs first. Maximum follow-up at the time of analysis was 4.6 years. The 1- and 2-year estimates are reported.

Population: Randomized participants

Locoregional failure is defined as local-regional progression or recurrence, death due to study cancer or unknown causes, salvage neck dissection with tumor present/unknown. Locoregional failure rates are estimated the cumulative incidence method, treating distant metastasis and death due to any reason other than study cancer or unknown as competing risks, and otherwise censoring participants alive at time of analysis. Each experimental arm is compared to the standard arm (Arm I).

Outcome measures

Outcome measures
Measure	Arm I (Standard RT + Cisplatin) n=136 Participants Patients undergo standard dose RT as 70 Gy IMRT or IGRT over 6 fractions per week and receive 100 mg/m\^2/day cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.	Arm II (Reduced RT+ Cisplatin) n=116 Participants Patients undergo reduced dose RT as 60 Gy IMRT or IGRT QD over 5 fractions per week and receive 100 mg/m\^2/day cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.	Arm III (Reduced RT + Nivolumab) n=132 Participants Beginning 1 week prior to radiation, patients receive 240 mg fixed dose nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks (14 days) for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo reduced dose RT as 60 Gy IMRT or IGRT over 6 fractions per week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.
Locoregional Failure (Percentage of Participants With Locoregional Failure) 1 year	0.0 percentage of participants Cannot be calculated for zero.	2.7 percentage of participants Interval 0.7 to 7.0	1.7 percentage of participants Interval 0.3 to 5.4
Locoregional Failure (Percentage of Participants With Locoregional Failure) 2 years	0.0 percentage of participants Cannot be calculated for zero.	6.5 percentage of participants Interval 2.8 to 12.2	5.0 percentage of participants Interval 1.8 to 10.6

SECONDARY outcome

Population: Randomized participants

Distant failure is defined as the occurrence of distant metastasis. Distant failure rates are estimated the cumulative incidence method, treating local-regional progression or recurrence, death due to any reason, salvage neck dissection with tumor present/unknown as competing risks, and otherwise censoring participants alive at time of analysis. Each experimental arm is compared to the standard arm (Arm I).

Outcome measures

Outcome measures
Measure	Arm I (Standard RT + Cisplatin) n=136 Participants Patients undergo standard dose RT as 70 Gy IMRT or IGRT over 6 fractions per week and receive 100 mg/m\^2/day cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.	Arm II (Reduced RT+ Cisplatin) n=116 Participants Patients undergo reduced dose RT as 60 Gy IMRT or IGRT QD over 5 fractions per week and receive 100 mg/m\^2/day cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.	Arm III (Reduced RT + Nivolumab) n=132 Participants Beginning 1 week prior to radiation, patients receive 240 mg fixed dose nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks (14 days) for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo reduced dose RT as 60 Gy IMRT or IGRT over 6 fractions per week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.
Distant Failure (Percentage of Participants With Distant Failure) Year 1	0.9 percentage of participants Interval 0.1 to 4.5	0.0 percentage of participants Cannot be calculated for zero.	0.8 percentage of participants Interval 0.1 to 4.2
Distant Failure (Percentage of Participants With Distant Failure) Year 2	1.9 percentage of participants Interval 0.4 to 6.2	4.1 percentage of participants Interval 1.3 to 9.4	2.9 percentage of participants Interval 0.8 to 7.8

SECONDARY outcome

Timeframe: From randomization to death from any cause or last follow-up. Maximum follow-up at the time of analysis was 4.6 years. The 1- and 2-year estimates are reported.

Population: Randomized participants

Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.

Outcome measures

Outcome measures
Measure	Arm I (Standard RT + Cisplatin) n=136 Participants Patients undergo standard dose RT as 70 Gy IMRT or IGRT over 6 fractions per week and receive 100 mg/m\^2/day cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.	Arm II (Reduced RT+ Cisplatin) n=116 Participants Patients undergo reduced dose RT as 60 Gy IMRT or IGRT QD over 5 fractions per week and receive 100 mg/m\^2/day cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.	Arm III (Reduced RT + Nivolumab) n=132 Participants Beginning 1 week prior to radiation, patients receive 240 mg fixed dose nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks (14 days) for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo reduced dose RT as 60 Gy IMRT or IGRT over 6 fractions per week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.
Overall Survival (Percentage of Participants Alive) 1 year	100 Percent of participants Cannot be calculated for 100.	99.1 Percent of participants Interval 97.4 to 100.0	99.2 Percent of participants Interval 97.5 to 100.0
Overall Survival (Percentage of Participants Alive) 2 year	99.0 Percent of participants Interval 97.0 to 100.0	98.0 Percent of participants Interval 95.2 to 100.0	96.1 Percent of participants Interval 92.3 to 99.9

SECONDARY outcome

Timeframe: From randomization to last known follow-up. Maximum follow-up at the time of analysis was 4.6 years.

Population: Randomized and started protocol treatment.

Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

Outcome measures

Outcome measures
Measure	Arm I (Standard RT + Cisplatin) n=123 Participants Patients undergo standard dose RT as 70 Gy IMRT or IGRT over 6 fractions per week and receive 100 mg/m\^2/day cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.	Arm II (Reduced RT+ Cisplatin) n=112 Participants Patients undergo reduced dose RT as 60 Gy IMRT or IGRT QD over 5 fractions per week and receive 100 mg/m\^2/day cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.	Arm III (Reduced RT + Nivolumab) n=123 Participants Beginning 1 week prior to radiation, patients receive 240 mg fixed dose nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks (14 days) for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo reduced dose RT as 60 Gy IMRT or IGRT over 6 fractions per week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.
Number of Participants by Highest Grade Adverse Event Reported Grade 4	15 Participants	15 Participants	8 Participants
Number of Participants by Highest Grade Adverse Event Reported Grade 1	3 Participants	4 Participants	4 Participants
Number of Participants by Highest Grade Adverse Event Reported Grade 2	37 Participants	27 Participants	38 Participants
Number of Participants by Highest Grade Adverse Event Reported Grade 3	68 Participants	66 Participants	72 Participants

SECONDARY outcome

Timeframe: Baseline up to 24 months from end of radiation therapy (RT)

Measured as Hearing Handicap Inventory for Adults-Screening (HHIA-S).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 24 months from end of RT

Measured by the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ)30.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Will be associated with PFS.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 1 and 2 years

The negative predictive value of FDG-PET/CT for locoregional control will be estimated using binomial proportions and confidence intervals based on normal approximation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 1 and 2 years

The negative predictive value of FDG-PET/CT PFS will be estimated using binomial proportions and confidence intervals based on normal approximation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Measured using Patient-Reported Outcomes (PRO)-CTCAE. For each symptom, counts and frequencies will be provided for the worst score experienced by the patient by treatment arm. The proportion of patients with scores \>= 1 and \>= 3 will be compared between groups using a Chi-square test, or Fisher's exact test if cell frequencies are \< 5, using a significance level of 0.05. Analysis of changes in patient reported outcomes over time will analyzed by fitting generalized estimating equations (GEE) models using a logit link (dichotomizing the symptom scores as 0 vs. \> 1 and 0-2 vs. 3-4) with time of assessment, treatment arm, and treatment-by-time interaction terms in the model.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 24 months from end of RT

Measured by EuroQol-5 Dimensional- 5 Level (EQ-5D-5L).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 years

Measured by a Modified Barium Swallow (MBS) test. The proportion of aspiration for each arm will be estimated assuming a binomial distribution and between arm comparison will be performed using a Fisher's exact test.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At 12-14 weeks post-RT

Locoregional control rates will be compared between negative and positive/undetermined patients. Cox proportional hazards models will be used to determine whether there are differences between these two groups, while adjusting for treatment arm and other covariates (cause-specific Cox models for locoregional failure).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At 12-14 weeks post-RT

PFS rates will be compared between negative and positive/undetermined patients. Cox proportional hazards models will be used to determine whether there are differences between these two groups, while adjusting for treatment arm and other covariates (cause-specific Cox models for locoregional failure).

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Standard RT + Cisplatin)

Serious events: 49 serious events

Other events: 123 other events

Deaths: 1 deaths

Arm II (Reduced RT+ Cisplatin)

Serious events: 32 serious events

Other events: 111 other events

Deaths: 6 deaths

Arm III (Reduced RT + Nivolumab)

Serious events: 34 serious events

Other events: 122 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Wendy Seiferheld

NRG Oncology

Phone: 215-574-3208

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60