Trial Outcomes & Findings for Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer (NCT NCT00798655)
NCT ID: NCT00798655
Last Updated: 2017-10-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Up to 90 months for cohort; individual patients up to 24 months after study treatment
Results posted on
2017-10-03
Participant Flow
Study included patients with pathologic stage III or IVA squamous cell carcinoma of the oral cavity, larynx, hypopharynx, or human-papillomavirus (HPV) -negative oropharynx, without gross residual tumor, featuring high-risk factors (margins \<1mm, extracapsular extension, perineural or angiolymphatic invasion, or ≥2 positive lymph nodes).
Participant milestones
| Measure |
Radiation Therapy+Cisplatin+Panitumumab
Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m\^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Radiation Therapy+Cisplatin+Panitumumab
Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m\^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
|
|---|---|
|
Overall Study
Did not receive at least one dose of pan
|
2
|
Baseline Characteristics
Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Radiation Therapy+Cisplatin+Panitumumab
n=44 Participants
Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m\^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 90 months for cohort; individual patients up to 24 months after study treatmentPopulation: Patients who received 60-66 Gy over 6-7 weeks) concurrent with cisplatin 30 mg/m\^2 and at least once dose of panitumumab 2.5 mg/kg.
Outcome measures
| Measure |
Radiation Therapy+Cisplatin+Panitumumab
n=44 Participants
Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m\^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
|
|---|---|
|
Probability of Progression-free Survival (PFS) at 2 Years
|
70 percentage of participants
Interval 58.0 to 85.0
|
SECONDARY outcome
Timeframe: Up to 90 months for cohort; individual patients up to 24 monthsPopulation: Patients who received 60-66 Gy over 6-7 weeks) concurrent with cisplatin 30 mg/m\^2 and at least once dose of panitumumab 2.5 mg/kg.
Outcome measures
| Measure |
Radiation Therapy+Cisplatin+Panitumumab
n=44 Participants
Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m\^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
|
|---|---|
|
Probability of 2-year Overall Survival
|
72 percentage of participants
Interval 60.0 to 87.0
|
Adverse Events
Radiation Therapy+Cisplatin+Panitumumab
Serious events: 18 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radiation Therapy+Cisplatin+Panitumumab
n=46 participants at risk
Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m\^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
2.2%
1/46
|
|
Gastrointestinal disorders
Anorexia
|
2.2%
1/46
|
|
Gastrointestinal disorders
Dehydration
|
2.2%
1/46
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
1/46
|
|
Nervous system disorders
Dizziness
|
2.2%
1/46
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
2.2%
1/46
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
2.2%
1/46
|
|
Infections and infestations
Febrile neutropenia
|
2.2%
1/46
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.2%
1/46
|
|
Cardiac disorders
Hypotension
|
2.2%
1/46
|
|
Infections and infestations
Infection - Other (Specify, __)
|
2.2%
1/46
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Trachea
|
2.2%
1/46
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.5%
3/46
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam), Oral cavity
|
4.3%
2/46
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/46
|
|
General disorders
Pain, Chest/thorax NOS
|
2.2%
1/46
|
|
General disorders
Pain, Pain NOS
|
2.2%
1/46
|
|
Nervous system disorders
Psychosis (hallucinations/delusions)
|
2.2%
1/46
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/46
|
|
General disorders
Weight loss
|
2.2%
1/46
|
Other adverse events
| Measure |
Radiation Therapy+Cisplatin+Panitumumab
n=46 participants at risk
Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m\^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
|
|---|---|
|
Ear and labyrinth disorders
Auditory/Ear - Other (Specify, __)
|
6.5%
3/46
|
|
Ear and labyrinth disorders
Tinnitus
|
6.5%
3/46
|
|
Blood and lymphatic system disorders
Platelets
|
6.5%
3/46
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
6.5%
3/46
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.5%
3/46
|
|
Blood and lymphatic system disorders
Hemoglobin
|
6.5%
3/46
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
6.5%
3/46
|
|
Cardiac disorders
Hypotension
|
6.5%
3/46
|
|
Cardiac disorders
Hypertension
|
6.5%
3/46
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
6.5%
3/46
|
|
General disorders
Rigors/chills
|
6.5%
3/46
|
|
General disorders
Insomnia
|
8.7%
4/46
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
8.7%
4/46
|
|
General disorders
Weight loss
|
8.7%
4/46
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
8.7%
4/46
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
8.7%
4/46
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
8.7%
4/46
|
|
Skin and subcutaneous tissue disorders
Wound complication, non-infectious
|
8.7%
4/46
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
8.7%
4/46
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
8.7%
4/46
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
10.9%
5/46
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.9%
5/46
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation, Chemoradiation
|
10.9%
5/46
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation, Radiation
|
10.9%
5/46
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
10.9%
5/46
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
13.0%
6/46
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __)
|
13.0%
6/46
|
|
Gastrointestinal disorders
Dehydration
|
13.0%
6/46
|
|
Gastrointestinal disorders
Diarrhea
|
13.0%
6/46
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
15.2%
7/46
|
|
Gastrointestinal disorders
Salivary gland changes/saliva
|
15.2%
7/46
|
|
Gastrointestinal disorders
Anorexia
|
15.2%
7/46
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
15.2%
7/46
|
|
Gastrointestinal disorders
Vomiting
|
15.2%
7/46
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
15.2%
7/46
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic), Oral cavity
|
17.4%
8/46
|
|
Gastrointestinal disorders
Constipation
|
17.4%
8/46
|
|
Gastrointestinal disorders
Nausea
|
17.4%
8/46
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
17.4%
8/46
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam), Oral cavity
|
17.4%
8/46
|
|
Infections and infestations
Infection - Other (Specify, __)
|
19.6%
9/46
|
|
Blood and lymphatic system disorders
Lymphatics - Other (Specify, __)
|
19.6%
9/46
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
21.7%
10/46
|
|
Metabolism and nutrition disorders
Creatinine
|
21.7%
10/46
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
21.7%
10/46
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
21.7%
10/46
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
23.9%
11/46
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
23.9%
11/46
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
23.9%
11/46
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
26.1%
12/46
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (Specify, __)
|
28.3%
13/46
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
30.4%
14/46
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
30.4%
14/46
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
32.6%
15/46
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
32.6%
15/46
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
32.6%
15/46
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
32.6%
15/46
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
34.8%
16/46
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
39.1%
18/46
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
41.3%
19/46
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
47.8%
22/46
|
|
Nervous system disorders
Mood alteration, Depression
|
47.8%
22/46
|
|
Nervous system disorders
Dizziness
|
50.0%
23/46
|
|
Nervous system disorders
Neurology - Other (Specify, __)
|
52.2%
24/46
|
|
Nervous system disorders
Mood alteration, Anxiety
|
52.2%
24/46
|
|
General disorders
Pain, Esophagus
|
58.7%
27/46
|
|
General disorders
Pain, Pain NOS
|
58.7%
27/46
|
|
General disorders
Pain, Neck
|
63.0%
29/46
|
|
General disorders
Pain, Throat/pharynx/larynx
|
63.0%
29/46
|
|
General disorders
Pain, Oral cavity
|
65.2%
30/46
|
|
General disorders
Pain - Other (Specify, __)
|
65.2%
30/46
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
67.4%
31/46
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
67.4%
31/46
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
76.1%
35/46
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
76.1%
35/46
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place