Trial Outcomes & Findings for De-Escalation Therapy for Human Papillomavirus Negative Disease (NCT NCT03944915)
NCT ID: NCT03944915
Last Updated: 2025-05-11
Results Overview
DRR is 50% or greater response to induction therapy based on RECIST criteria. The objective is to intensify induction chemotherapy with the addition of an immune checkpoint inhibitor aimed at increasing the proportion of patients achieving a deep tumor response in order to subsequently allow risk-adapted definitive chemoradiotherapy in advanced stage HPV negative head and neck squamous cell cancer patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
2 years
Results posted on
2025-05-11
Participant Flow
Participant milestones
| Measure |
Standard Chemotherapy
Induction Therapy
Carboplatin: Carboplatin will be given through IV infusions for 30-60 minutes on day 1 of each cycle. Each cycle will last 21 days. There will be 3 cycles.
Paclitaxel: During Induction Therapy Paclitaxel (100 mg) will be given through IV infusions on days 1, 8 and 15 of each 21 day cycle. There will be 3 cycles.
During Radiotherapy, paclitaxel will be given after a dose of radiation by IV infusion for 60 minutes after day 1 of radiotherapy.
Nivolumab: Nivolumab will be given through IV infusions at 360 mg on day 1 every 21 days for 3 cycles.
|
De-escalated Chemotherapy
Radiation therapy with chemotherapy
Paclitaxel: During Induction Therapy Paclitaxel (100 mg) will be given through IV infusions on days 1, 8 and 15 of each 21 day cycle. There will be 3 cycles.
During Radiotherapy, paclitaxel will be given after a dose of radiation by IV infusion for 60 minutes after day 1 of radiotherapy.
Radiation: Patients will receive 4.5-5 cycles of radiation depending on response. Those with a positive response will receive radiation for 4.5 cycles with a total radiation dose of 66 Gy. Patients with a moderate or no response will receive 5 cycles with a total radiation dose of 70-75 Gy. 2 times a day for days 1-5 followed by a rest period for days 6-13
Hydroxyurea Pill: One dose of hydroxyurea pill by mouth at start of 5-FU infusion during radiotherapy cycle
5-fluorouracil: 5-FU will be given by IV infusion continuously for 5 days during radiotherapy cycles
Filgrastim Injection: Filgrastim shot will be given if patient has certain side effects during radiotherapy cycle on days 6-12.
Cisplatin: Radiotherapy may also be given with a different chemotherapy agent called cisplatin. This is the traditional standard of care chemotherapy regimen. In this case, the radiotherapy will be given once daily for 5 days per week. Cisplatin will be administered via IV once every 21 days for 2 or 3 cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
19
|
|
Overall Study
COMPLETED
|
16
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
De-Escalation Therapy for Human Papillomavirus Negative Disease
Baseline characteristics by cohort
| Measure |
Standard Chemotherapy
n=16 Participants
Standard chemoradiotherapy with paclitaxel, 5-FU, hydroxyurea and hyperfractionated, accelerated radiotherapy to 75 Gy encompassing GTV of primary and nodal disease as well as elective prophylactic nodal irradiation. OR Standard chemoradiotherapy with cisplatin and radiotherapy to 70 Gy encompassing GTV of primary and nodal disease as well as elective prophylactic nodal irradiation
|
De-escalated Chemotherapy
n=19 Participants
De-escalated chemoradiotherapy with paclitaxel, 5-FU, hydroxyurea and hyperfractionated, accelerated radiotherapy to 66 Gy encompassing GTV of primary and nodal disease without elective prophylactic nodal irradiation. OR De-escalated chemoradiotherapy with cisplatin and radiotherapy to 66 Gy encompassing GTV of primary and nodal disease without elective prophylactic nodal irradiation.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Continuous
|
57.0 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
19 participants
n=7 Participants
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsDRR is 50% or greater response to induction therapy based on RECIST criteria. The objective is to intensify induction chemotherapy with the addition of an immune checkpoint inhibitor aimed at increasing the proportion of patients achieving a deep tumor response in order to subsequently allow risk-adapted definitive chemoradiotherapy in advanced stage HPV negative head and neck squamous cell cancer patients.
Outcome measures
| Measure |
Standard Chemotherapy
n=16 Participants
Standard chemoradiotherapy with paclitaxel, 5-FU, hydroxyurea and hyperfractionated, accelerated radiotherapy to 75 Gy encompassing GTV of primary and nodal disease as well as elective prophylactic nodal irradiation. OR Standard chemoradiotherapy with cisplatin and radiotherapy to 70 Gy encompassing GTV of primary and nodal disease as well as elective prophylactic nodal irradiation
|
De-escalated Chemotherapy
n=19 Participants
De-escalated chemoradiotherapy with paclitaxel, 5-FU, hydroxyurea and hyperfractionated, accelerated radiotherapy to 66 Gy encompassing GTV of primary and nodal disease without elective prophylactic nodal irradiation. OR De-escalated chemoradiotherapy with cisplatin and radiotherapy to 66 Gy encompassing GTV of primary and nodal disease without elective prophylactic nodal irradiation.
|
|---|---|---|
|
Deep Response Rate (DRR)
|
16 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 26 monthsProgression free survival at 24 months after completing chemoradiation. PFS will be defined as the time from registration to the date of the first documented disease progression, clinical progression, or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Standard Chemotherapy
n=16 Participants
Standard chemoradiotherapy with paclitaxel, 5-FU, hydroxyurea and hyperfractionated, accelerated radiotherapy to 75 Gy encompassing GTV of primary and nodal disease as well as elective prophylactic nodal irradiation. OR Standard chemoradiotherapy with cisplatin and radiotherapy to 70 Gy encompassing GTV of primary and nodal disease as well as elective prophylactic nodal irradiation
|
De-escalated Chemotherapy
n=19 Participants
De-escalated chemoradiotherapy with paclitaxel, 5-FU, hydroxyurea and hyperfractionated, accelerated radiotherapy to 66 Gy encompassing GTV of primary and nodal disease without elective prophylactic nodal irradiation. OR De-escalated chemoradiotherapy with cisplatin and radiotherapy to 66 Gy encompassing GTV of primary and nodal disease without elective prophylactic nodal irradiation.
|
|---|---|---|
|
Progression Free Survival Rate (PFS)
|
69 percentage of patients in each arm
Interval 40.0 to 86.0
|
69 percentage of patients in each arm
Interval 39.0 to 87.0
|
SECONDARY outcome
Timeframe: 26 monthsOverall survival will be defined as the time between the date of registration and the date of death.
Outcome measures
| Measure |
Standard Chemotherapy
n=16 Participants
Standard chemoradiotherapy with paclitaxel, 5-FU, hydroxyurea and hyperfractionated, accelerated radiotherapy to 75 Gy encompassing GTV of primary and nodal disease as well as elective prophylactic nodal irradiation. OR Standard chemoradiotherapy with cisplatin and radiotherapy to 70 Gy encompassing GTV of primary and nodal disease as well as elective prophylactic nodal irradiation
|
De-escalated Chemotherapy
n=19 Participants
De-escalated chemoradiotherapy with paclitaxel, 5-FU, hydroxyurea and hyperfractionated, accelerated radiotherapy to 66 Gy encompassing GTV of primary and nodal disease without elective prophylactic nodal irradiation. OR De-escalated chemoradiotherapy with cisplatin and radiotherapy to 66 Gy encompassing GTV of primary and nodal disease without elective prophylactic nodal irradiation.
|
|---|---|---|
|
Overall Survival Rate (OS)
|
79 percentage of patients in each arm
Interval 47.0 to 93.0
|
74 percentage of patients in each arm
Interval 41.0 to 90.0
|
SECONDARY outcome
Timeframe: 26 monthsAssess disease control in all patients receiving induction chemoimmunotherapy and compare disease control between radiation arms.
Outcome measures
| Measure |
Standard Chemotherapy
n=16 Participants
Standard chemoradiotherapy with paclitaxel, 5-FU, hydroxyurea and hyperfractionated, accelerated radiotherapy to 75 Gy encompassing GTV of primary and nodal disease as well as elective prophylactic nodal irradiation. OR Standard chemoradiotherapy with cisplatin and radiotherapy to 70 Gy encompassing GTV of primary and nodal disease as well as elective prophylactic nodal irradiation
|
De-escalated Chemotherapy
n=19 Participants
De-escalated chemoradiotherapy with paclitaxel, 5-FU, hydroxyurea and hyperfractionated, accelerated radiotherapy to 66 Gy encompassing GTV of primary and nodal disease without elective prophylactic nodal irradiation. OR De-escalated chemoradiotherapy with cisplatin and radiotherapy to 66 Gy encompassing GTV of primary and nodal disease without elective prophylactic nodal irradiation.
|
|---|---|---|
|
Locoregional Control After Completing Chemoradiation
|
93 percentage of patients in each arm
Interval 61.0 to 99.0
|
89 percentage of patients in each arm
Interval 63.0 to 97.0
|
SECONDARY outcome
Timeframe: 26 monthsDistant control will be defined as the percent of patients with disease progression below the clavicles. Comparison between the two radiation arms will be made.
Outcome measures
| Measure |
Standard Chemotherapy
n=16 Participants
Standard chemoradiotherapy with paclitaxel, 5-FU, hydroxyurea and hyperfractionated, accelerated radiotherapy to 75 Gy encompassing GTV of primary and nodal disease as well as elective prophylactic nodal irradiation. OR Standard chemoradiotherapy with cisplatin and radiotherapy to 70 Gy encompassing GTV of primary and nodal disease as well as elective prophylactic nodal irradiation
|
De-escalated Chemotherapy
n=19 Participants
De-escalated chemoradiotherapy with paclitaxel, 5-FU, hydroxyurea and hyperfractionated, accelerated radiotherapy to 66 Gy encompassing GTV of primary and nodal disease without elective prophylactic nodal irradiation. OR De-escalated chemoradiotherapy with cisplatin and radiotherapy to 66 Gy encompassing GTV of primary and nodal disease without elective prophylactic nodal irradiation.
|
|---|---|---|
|
Distant Control After Completing Chemoradiation
|
90 percentage of patients in each arm
Interval 47.0 to 99.0
|
94 percentage of patients in each arm
Interval 63.0 to 99.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearAssess long term and late toxicities in all patients receiving induction therapy and risk-adapted chemoradiotherapy after deep response to induction therapy. Acute and late toxicities will be defined using the National Cancer Institute Common Terminology Criteria for Adverse Events. Comparisons will be made using Fisher's exact test. Acute and late toxicity during treatment and at 1 month, 3 months and 1 year post chemoradiation
Outcome measures
| Measure |
Standard Chemotherapy
n=16 Participants
Standard chemoradiotherapy with paclitaxel, 5-FU, hydroxyurea and hyperfractionated, accelerated radiotherapy to 75 Gy encompassing GTV of primary and nodal disease as well as elective prophylactic nodal irradiation. OR Standard chemoradiotherapy with cisplatin and radiotherapy to 70 Gy encompassing GTV of primary and nodal disease as well as elective prophylactic nodal irradiation
|
De-escalated Chemotherapy
n=19 Participants
De-escalated chemoradiotherapy with paclitaxel, 5-FU, hydroxyurea and hyperfractionated, accelerated radiotherapy to 66 Gy encompassing GTV of primary and nodal disease without elective prophylactic nodal irradiation. OR De-escalated chemoradiotherapy with cisplatin and radiotherapy to 66 Gy encompassing GTV of primary and nodal disease without elective prophylactic nodal irradiation.
|
|---|---|---|
|
Acute and Late Toxicity During Treatment
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearEnteral tube dependency will be defined as continued necessity of any nutrition through enteral tube to maintain weight. The rate of enteral tube dependency will be described within the safety population and among each radiation treatment. Comparisons will be made using Fisher's exact test.
Outcome measures
| Measure |
Standard Chemotherapy
n=16 Participants
Standard chemoradiotherapy with paclitaxel, 5-FU, hydroxyurea and hyperfractionated, accelerated radiotherapy to 75 Gy encompassing GTV of primary and nodal disease as well as elective prophylactic nodal irradiation. OR Standard chemoradiotherapy with cisplatin and radiotherapy to 70 Gy encompassing GTV of primary and nodal disease as well as elective prophylactic nodal irradiation
|
De-escalated Chemotherapy
n=19 Participants
De-escalated chemoradiotherapy with paclitaxel, 5-FU, hydroxyurea and hyperfractionated, accelerated radiotherapy to 66 Gy encompassing GTV of primary and nodal disease without elective prophylactic nodal irradiation. OR De-escalated chemoradiotherapy with cisplatin and radiotherapy to 66 Gy encompassing GTV of primary and nodal disease without elective prophylactic nodal irradiation.
|
|---|---|---|
|
Enteral Tube Dependency
|
3 participants
|
3 participants
|
Adverse Events
Standard Chemotherapy
Serious events: 0 serious events
Other events: 15 other events
Deaths: 3 deaths
De-escalated Chemotherapy
Serious events: 0 serious events
Other events: 15 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Chemotherapy
n=16 participants at risk
Standard chemoradiotherapy with paclitaxel, 5-FU, hydroxyurea and hyperfractionated, accelerated radiotherapy to 75 Gy encompassing GTV of primary and nodal disease as well as elective prophylactic nodal irradiation. OR Standard chemoradiotherapy with cisplatin and radiotherapy to 70 Gy encompassing GTV of primary and nodal disease as well as elective prophylactic nodal irradiation
|
De-escalated Chemotherapy
n=19 participants at risk
De-escalated chemoradiotherapy with paclitaxel, 5-FU, hydroxyurea and hyperfractionated, accelerated radiotherapy to 66 Gy encompassing GTV of primary and nodal disease without elective prophylactic nodal irradiation. OR De-escalated chemoradiotherapy with cisplatin and radiotherapy to 66 Gy encompassing GTV of primary and nodal disease without elective prophylactic nodal irradiation.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.2%
1/16 • Number of events 2 • 26 months
|
0.00%
0/19 • 26 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/16 • 26 months
|
10.5%
2/19 • Number of events 2 • 26 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
43.8%
7/16 • Number of events 11 • 26 months
|
21.1%
4/19 • Number of events 6 • 26 months
|
|
Vascular disorders
Hot flashes
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Vascular disorders
Hypertension
|
12.5%
2/16 • Number of events 10 • 26 months
|
5.3%
1/19 • Number of events 2 • 26 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • 26 months
|
15.8%
3/19 • Number of events 3 • 26 months
|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
2/16 • Number of events 2 • 26 months
|
31.6%
6/19 • Number of events 12 • 26 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Cardiac disorders
Atrial Fibrillation
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Cardiac disorders
Sinus tachycardia
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • 26 months
|
5.3%
1/19 • Number of events 2 • 26 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
18.8%
3/16 • Number of events 6 • 26 months
|
15.8%
3/19 • Number of events 3 • 26 months
|
|
Ear and labyrinth disorders
Tinnitus
|
43.8%
7/16 • Number of events 7 • 26 months
|
36.8%
7/19 • Number of events 8 • 26 months
|
|
Ear and labyrinth disorders
Vertigo
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Endocrine disorders
Hypothyroidism
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Eye disorders
Blurred vision
|
6.2%
1/16 • Number of events 1 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Eye disorders
Eye disorders - Other, specify
|
12.5%
2/16 • Number of events 2 • 26 months
|
0.00%
0/19 • 26 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
2/16 • Number of events 2 • 26 months
|
10.5%
2/19 • Number of events 2 • 26 months
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/16 • 26 months
|
10.5%
2/19 • Number of events 2 • 26 months
|
|
Gastrointestinal disorders
Constipation
|
50.0%
8/16 • Number of events 8 • 26 months
|
36.8%
7/19 • Number of events 8 • 26 months
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
4/16 • Number of events 5 • 26 months
|
26.3%
5/19 • Number of events 5 • 26 months
|
|
Gastrointestinal disorders
Dry mouth
|
62.5%
10/16 • Number of events 11 • 26 months
|
36.8%
7/19 • Number of events 9 • 26 months
|
|
Gastrointestinal disorders
Dysphagia
|
31.2%
5/16 • Number of events 6 • 26 months
|
26.3%
5/19 • Number of events 6 • 26 months
|
|
Gastrointestinal disorders
Esophagitis
|
18.8%
3/16 • Number of events 4 • 26 months
|
10.5%
2/19 • Number of events 2 • 26 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Gastrointestinal disorders
Mucositis oral
|
93.8%
15/16 • Number of events 36 • 26 months
|
73.7%
14/19 • Number of events 34 • 26 months
|
|
Gastrointestinal disorders
Nausea
|
43.8%
7/16 • Number of events 9 • 26 months
|
31.6%
6/19 • Number of events 8 • 26 months
|
|
Gastrointestinal disorders
Oral pain
|
6.2%
1/16 • Number of events 1 • 26 months
|
15.8%
3/19 • Number of events 3 • 26 months
|
|
Gastrointestinal disorders
Vomiting
|
43.8%
7/16 • Number of events 8 • 26 months
|
10.5%
2/19 • Number of events 4 • 26 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
56.2%
9/16 • Number of events 15 • 26 months
|
57.9%
11/19 • Number of events 25 • 26 months
|
|
General disorders
Chills
|
6.2%
1/16 • Number of events 1 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
General disorders
Edema limbs
|
18.8%
3/16 • Number of events 5 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
General disorders
Fatigue
|
18.8%
3/16 • Number of events 3 • 26 months
|
31.6%
6/19 • Number of events 7 • 26 months
|
|
General disorders
Gait disturbance
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
General disorders
Hypothermia
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
General disorders
Injection site reaction
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
General disorders
Malaise
|
0.00%
0/16 • 26 months
|
10.5%
2/19 • Number of events 2 • 26 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
6.2%
1/16 • Number of events 1 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Immune system disorders
Immune system disorders - Other, specify
|
12.5%
2/16 • Number of events 2 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Infections and infestations
Paronychia
|
6.2%
1/16 • Number of events 2 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
12.5%
2/16 • Number of events 2 • 26 months
|
0.00%
0/19 • 26 months
|
|
Injury, poisoning and procedural complications
Bruising
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
87.5%
14/16 • Number of events 33 • 26 months
|
68.4%
13/19 • Number of events 25 • 26 months
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Number of events 2 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
1/16 • Number of events 7 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Investigations
Alkaline phosphatase increased
|
6.2%
1/16 • Number of events 5 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
1/16 • Number of events 2 • 26 months
|
0.00%
0/19 • 26 months
|
|
Investigations
Creatinine increased
|
18.8%
3/16 • Number of events 3 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Investigations
Neutrophil count decreased
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 2 • 26 months
|
|
Investigations
Weight loss
|
25.0%
4/16 • Number of events 4 • 26 months
|
15.8%
3/19 • Number of events 3 • 26 months
|
|
Investigations
White blood cell decreased
|
0.00%
0/16 • 26 months
|
10.5%
2/19 • Number of events 3 • 26 months
|
|
Metabolism and nutrition disorders
Anorexia
|
31.2%
5/16 • Number of events 7 • 26 months
|
36.8%
7/19 • Number of events 7 • 26 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
18.8%
3/16 • Number of events 3 • 26 months
|
0.00%
0/19 • 26 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
37.5%
6/16 • Number of events 9 • 26 months
|
21.1%
4/19 • Number of events 4 • 26 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
31.2%
5/16 • Number of events 7 • 26 months
|
5.3%
1/19 • Number of events 2 • 26 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.8%
3/16 • Number of events 6 • 26 months
|
10.5%
2/19 • Number of events 3 • 26 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.5%
2/16 • Number of events 2 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Metabolism and nutrition disorders
Obesity
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • 26 months
|
10.5%
2/19 • Number of events 2 • 26 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/16 • 26 months
|
10.5%
2/19 • Number of events 2 • 26 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
6.2%
1/16 • Number of events 1 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Nervous system disorders
Aphonia
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 2 • 26 months
|
|
Nervous system disorders
Dizziness
|
12.5%
2/16 • Number of events 2 • 26 months
|
10.5%
2/19 • Number of events 2 • 26 months
|
|
Nervous system disorders
Dysarthria
|
6.2%
1/16 • Number of events 1 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Nervous system disorders
Dysgeusia
|
62.5%
10/16 • Number of events 13 • 26 months
|
42.1%
8/19 • Number of events 11 • 26 months
|
|
Nervous system disorders
Dysphasia
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Nervous system disorders
Lethargy
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
37.5%
6/16 • Number of events 8 • 26 months
|
21.1%
4/19 • Number of events 6 • 26 months
|
|
Nervous system disorders
Presyncope
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Nervous system disorders
Stroke
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 2 • 26 months
|
|
Nervous system disorders
Tremor
|
6.2%
1/16 • Number of events 1 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Psychiatric disorders
Agitation
|
12.5%
2/16 • Number of events 2 • 26 months
|
0.00%
0/19 • 26 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Psychiatric disorders
Confusion
|
12.5%
2/16 • Number of events 5 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Psychiatric disorders
Delirium
|
6.2%
1/16 • Number of events 2 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
1/16 • Number of events 1 • 26 months
|
21.1%
4/19 • Number of events 5 • 26 months
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Renal and urinary disorders
Urinary incontinence
|
6.2%
1/16 • Number of events 2 • 26 months
|
0.00%
0/19 • 26 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
6.2%
1/16 • Number of events 1 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Number of events 2 • 26 months
|
15.8%
3/19 • Number of events 4 • 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
2/16 • Number of events 2 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16 • Number of events 1 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
6.2%
1/16 • Number of events 1 • 26 months
|
15.8%
3/19 • Number of events 3 • 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
18.8%
3/16 • Number of events 3 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.5%
2/16 • Number of events 2 • 26 months
|
10.5%
2/19 • Number of events 2 • 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
43.8%
7/16 • Number of events 9 • 26 months
|
42.1%
8/19 • Number of events 9 • 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.2%
1/16 • Number of events 1 • 26 months
|
0.00%
0/19 • 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
37.5%
6/16 • Number of events 10 • 26 months
|
21.1%
4/19 • Number of events 4 • 26 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/16 • 26 months
|
5.3%
1/19 • Number of events 1 • 26 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
18.8%
3/16 • Number of events 5 • 26 months
|
10.5%
2/19 • Number of events 2 • 26 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place